WWW - Kfda.go - KR: Registration Number 11-1470000-001902-01

Registration Number 11-1470000-001902-01
2011 KFDA Report
2011 KFDA Report
Korea
www.kfda.go.kr
Food
Drug
Administration
187 Osongsaengmyeong2(i)-ro, Gangoe-myeon, Cheongwon-gun, Chungcheongbuk-do, Korea 363-951 Tel : +82-1577-1255
Registration Number 11-1470000-001902-01
2011 KFDA Report
2011 KFDA Report

Year 2011 is an exceptionally memorable year for the Korea Food and Drug Administration. It marks the first year since the KFDA relocated to its current home of Osong in Chungbuk province. With the completion of the relocation project, the KFDA set several initiatives to celebrate the new era at the new location. The vision of the administration is Global Top 5 by 2020. It conveys the administrations determination to achieve the highest level of public health out of the world and to become one of the top five regulatory agencies by securing the safety of food and drug. The KFDA will do its best to achieve its goal of To actualize above vision, the KFDA proposed six priority tasks. 1. Enhancing preventive risk management system 2. Tightening safety management, from raw materials to final product 3. Supporting competitive new growth engine industries 4. Reforming regulations to promote autonomy and fairness 5. Invigorating communication to spread safety recognition 6. Strengthening cooperative system to establish a basis for safety December 2011 The KFDA has also initiated 3 year projects on establishing safety infrastructures at the standards of advanced countries, supporting new growth engine industries and preparing effective response systems. It will support the field of advanced biopharmaceuticals and medical devices with combined technologies, to facilitate efficient product commercialization with our expertise. becoming one of the top 5 agencies in the field of food and drug. It will also continue to carry out its function as a regulatory agency for food, drug, cosmetics and medical device, to protect and secure the health of the nation. In 2010, the KFDA revised 80 different regulatory measures and received the honor of being awarded as the best government organization in regulatory reform. It successfully established a foundation in Osong for its future development as biotechnology cluster of 21st century. All of our achievements are available in this report.
Yun-Hong Noh
the Commissioner of the Korea Food and Drug Administration
Korea Food & Drug Administration
Regulatory Reform to Enhance the Public Assurance, 22 01 Industry Activity and the Nation's Status
CONTENTS
Introduction
22 22 25
1. Regulatory Reform Directions of 2010 2. Details of Regulatory Reform 3. Regulatory Reform Assessment
Successful Relocation of Osong Health Technology 26 02 Administration Complex

26 26 27 1. Outline 2. Relocation Task Conditions 3. New Era of the KFDA at Osong
28 03 International Trade and Cooperation in Food and Drug 14 15 16 18 01 The Top 6 Priority Tasks 02 Missions 03 History 04 Vision / Mission / Aim
28 28 31 1. Outline 2. International Trade 3. International Cooperation
Reinforcement of Cooperation with 33 04

33 36 37
Consumer Organization and Civil Affairs Administration Service
1. Establishment of Cooperative Network with Consumer Organizations 2. Civil Service KiFDA System 3. Telephone and Online Counseling
40 05 Policy Statistics to Manage Productions

40 40 44 1. Outline 2. Policy Statistics 3. Clinical Statistic
KOREA FOOD & DRUG ADMINISTRATION
48 06 Korea Internet Food and Drug Administration (KiFDA)

48 49 50 50 1. Background and Goal 2. Performance 3. Prospect Plan 4. Expected Effectiveness
51 07 Promotion of R&D - Supporting the Safety of the Public

51 55 55 57 57 58 1. Expansion of R&D Budget for Scientific Safety Management of Food and Drug 2. Establishment of Long Term Direction of R&D Projects 3. Expansion of Research and Development Institute to Combine Projects 4. Providing Service to Assist Researchers 5. Awarding Researcher to Promote Active Participation of Researchers 6. Performance Management to Promote the Usefulness of Investment for Research and Development Project
Chapter 01 Scope of Policy Support

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Food and Drug Risk Prevention and Dissemination of 62 01 Safety Information

63 63 65 1. Establishment of Risk Management System to Prevent Safety Incidents 2. Establishment of Food Control System through Anticipative Prevention 3. Risk Communication to Disseminate the Importance of Food and Drug Safety
Chapter 03 Food
Integrated Control System of Risk Information and 70 02 Reinforcement of Analysis Capability
72 03 Introduction of an Advanced Operation System in Foods

and Drugs Test and Inspection Organizations
72 1. Introduction of an Advanced Operation System in Foods and Drugs Test and Inspection Organizations
Preventive and Scientific Management Infrastructure of Food Hazards 76 01

76 81 1. Activation of Food Safety Management - Hazard Analysis Critical Control Point System (HACCP) 2. Real-Time Prevention System for Food Poisoning
91 02 Securing Health by Food and Nutrition Management

91 96 99 1. Management of Nutrition with Potential Risks: Sugar, Sodium and Trans Fat 2. Improvement of Nutritional Evaluation System for the Nations Nutrition Management 3. Improvement of Safety Management for Childrens Food
Preparing the Organic and Systematic Safety Management from Raw 105 03 Material to Consumption
105 110 113 114 116 1. Safety Management Activity for Food Distribution 2. Establishment of Safety Management System for Imported Food 3. Improvement of Safety Management for Alcohol 4. Establishment and Operation of Food Safety Information Center 5. Improvement of the Food Labeling System for Realization of Sovereignty of Customers
119 04 Establishment and Operation of Food Safety Information Center
Chapter 02 Risk Prevention
119 136
1. Safety Management of Health Functional Food 2. Improvement of Safety Management for Genetically Modified Food and Novel Food
Reorganizing Standards and Specification for Food, Food Additives, 142 05 Equipment, Container and Packaging
142 145 147 148 149 1. Management Food Standards and Specification 2. Systematical Management of Food Substance 3. Management of Food Additives Regulation 4. Management of Regulation and Specification for Utensils, Container and Packaging 5. Management of Standards and Specification for Disinfectant of Equipments
Conditions and Prospects of Biopharmaceutical Products 194 01 Administration
Chapter 04 Pharmaceutical Products
194 199 202
1. The Domestic-Global Trend of High Tech Biomedicine 2. Domestic and Foreign Trend of Vaccine Industry 3. Prospects of Biopharmaceutical Products
203 02 System Management of Biopharmaceutical Quality Assurance

203 204 204 1. Outline 2. Improvement in Management System of Pharmaceuticals Subject to National Testing 3. Establishment of the Safety Management System for Plasma Derivatives and Pharmaceuticals Derived from Human Placenta 4. Establishment of a Definition for Biological Products
Current Status and Progress in Pharmaceutical Product Safety 152 01 Management

152 156 158 1. Changes in Pharmaceutical Environment 2. Past Projects and Assessments 3. Directions in Pharmaceutical Safety Management
205
Fostering the Biopharmaceutical Products and Building the 206 03 Foundation of Support System
206 206 208 1. Outline 2. Innovation of the Customer-Focused Evaluation 3. Management of the Public-Private Communication Channel; Biopharmaceutical Industry Development Strategy Planning Group (Dynamic BIO)
160 02 Promoting Appropriate and Safe Use of Pharmaceuticals

160 161 162 164 166 167 1. Active Reporting of Adverse Effects and Scientific Assessment of Pharmaceutical Safety Information 2. Provision of Information on Appropriate Usage of Pharmaceutical Products 3. Establish Children-Friendly Environment for Drug Consumption 4. Activation of Network to Prohibit Distributions of Illicit and Defective Drugs 5. Reinforcement in Pharmaceutical Re-assessment and Review Management Systems 6. Establishment of Management System to Prevent Narcotic Drug Abuse
209 04 Safety Management of Human Tissue

209 211 213 1. Outline 2. Human Tissue System Reorganization 3. Enhancement of Follow-Up Control, Including Quality Control of Tissue Banks
Reinforcement of Safety Management Infrastructure for Medicine 214 05 and Herbal Medicine
214 218 1. Building the Safety Management System for Korean Herbal Medicine 2. Approval and Evaluation of Herbal Medicines
170 03 Assistance in Commercialization of Pharmaceuticals

170 172 1. Deregulation and System Improvement to Reinforce Global Competitiveness 2. Enhancement of Efficient, Transparent and Responsible Drug Approval and Evaluation
Establishment of Management System for Cosmetics and Sanitary 228 06 Aid

228 230 231 233 237 241 1. Current Conditions and Prospects of Cosmetics and Quasidrugs 2. Establishment of Foundations for Safe and Appropriate Use of Cosmetics and Quasi-drugs 3. Improvement of Industrial Competitiveness by Managing Safety in Production 4. Reinforcement of Safety Management for Distributed Cosmetics and Quasi-drugs 5. Increase in Transparency and Predictability of Evaluation 6. Reinforcement of International Cooperation for Cosmetics
Establishment of Foundation for Supply of Safe and Effective 178 04 Pharmaceuticals

178 182 1. Introduction and Application of Good Manufacturing Practice of Advanced Standards 2. International Harmonization to Achieve Advances in Pharmaceutical Safety Standards
186 05 International Cooperation in Pharmaceutical Sector

186 187 1. Pharmaceutical Products and Globalization 2. Current Status in International Trade and Cooperation
Chapter 05 Risk Prevention Area
246 01 The Condition and Direction of Medical Devices Safety Control

246 246 252 1. Policy Environment 2. The Actual Condition and Prospect of Medical Devices Industry 3. The Direction of Medical Devices Safety Management
Chapter 07 Food and Drug Safety Assessment
282 01 Building Advanced Foundation for Scientific Risk Assessment

282 282 284 286 287 1. Overview 2. Principles of Performing Risk Assessment 3. Performances of 2010 4. Action Plans for 2011 5. Expected Result
254 02 Improvement of Medical Devices Pre-Management System

254 256 257 260 261 263 1. Overview and Current Condition of Medical Devices Approval and Evaluation System 2. Current Condition of Medical Devices Approval and Evaluation System 3. Technical Document Review for Medical Devices 4. Safety and Efficacy Evaluation of Medical Devices 5. The Medical Devices, Which Were Approved through Safetyefficacy Evaluation in 2010, Are Listed below. 6. Provision of Technological Information and Method of Safe Use of Medical Devices for The Public
Enhancement of Status as an International Institute for Test 288 02 Analysis and Research
288 288 289 289 290 1. Overview 2. Development of Document Management System for Quality Assurance of Test Analysis 3. Production and Provision of Reference Standard 4. Enhancement and Development of Test 5. Construction of an Advanced Core Laboratory
International and Scientific Approaches to Medical Device Standards 265 03 and Specification
265 265 266 1. Overview 2. Current Status in Medical Devices Standards and Specifications 3. Future Directions
Providing Scientific Basis for Advanced License Screen 291 03 System and Safety Management
291 296 299 299 301 303 1. Study on the Safety Management of Pharmaceuticals 2. Research on the Safety Management of Biological Drugs 3. Study on the Safety Management of Herbal Medicines 4. Study on the Safety Management for Cosmetics and Quasidrugs 5. Study on the Safety Management of Medical Devices 6. Customized Support from Initial R&D Design to Final Drug Approval
267 04 Establishment of Medical Devices Quality Management System

267 268 1. Defining GMP System for Medical Devices 2. Improving GMP Operating System and Its International Standardization
272 05 Strengthened Post-Management of Medical Devices

272 273 1. Overview 2. Establishing a Reasonable Post-Management System Focusing on Safety
Improvement of Status of the Institute as an International 306 04

306 307 308 309 311 312 314 1. National Toxicology Program in Korea (KNTP) 2. Establishment of Toxicity Information Database 3. Study on the Basis of Toxicity from Nano-materials 4. Study on the Basis of Evaluation Technique for Toxicity 5. Study on the Prognosis of Safety on Drugs 6. Study on Pharmacogenomic Information and Evaluation Guidelines of Clinical Trials 7. Management and Study on Test Animal Resource
Safety Evaluation Institution through the Enhancement of Safety Evaluation Technique
Chapter 06 Medical Device Area
Upgrading National Prestige through Enhancing 316 05 International Cooperation

316 317 317 318 319 1. APEC Harmonization Center 2. International Cooperation on Alternative Animal Tests 3. Operation of WHO GLO Training Center in the Field of Biological Medicine 4. Operation of WHO Collaborating Centre for Biological Standardization 5. International Cooperation with EDQM
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Introduction
365, Happier Korea

01 The Top 6 Priority Tasks 02 Missions 03 History 04 Vision / Mission / Aim
365, Happier Korea

KFDA is protecting the safety and healthy life of people.
The Top 6 Priority Tasks

1. Enhancement of precautionary risk management system
Establishment of a '3-year plan on the enhancement of food and pharmaceutical safety' Establishment and improvement of safety standards for new risk factors to protect the public health
Missions
We will protect and improve the public health by securing the safety of food, pharmaceuticals, medical devices and etc. and promoting competitiveness of healthcare industries
Korea Food and Drug Administration (KFDA) (Headquarter)
Strategic organization based on development of safety control policies and control tower Performance of top 5 roles in reinforcing political and strategies Development of policies Establishment of standards Pre-market approval Post-market inspection Management of product quality system Evaluation department conducts establishment of standards, approval and review
2. Tightened safety control from raw materials to consumption

Reinforcement of the food safety control system in site Reinforcement of the quality and safety control of pharmaceuticals and etc. Establishment of the advanced safety control system for medical devices Establishment of the advanced safety control system from raw materials to consumption for cosmetics
3. Support for competitive new growth engine industries

Support for the reinforcement of international competitiveness of biopharmaceuticals Support for the development of high value-added medical devices Expansion of support system to enhance competitiveness of pharmaceuticals Promotion on product development of natural material pharmaceuticals and health functional food
4. Reform of the regulations on food and medicine promoting voluntariness and fairness
Leading zero-based reform for regulations to enhance industrial autonomy Reasonable revisions or adjustment of standards for punishment and penalty to reinforce autonomy and responsibility of industries
National Institute of Food and Drug Safety Evaluation (NiFDA ) A think-tank for scientific safety control
Research and development, risk assessment, test analysis, development of test methods and approval and evaluation methods, and etc. Establishment of the scientific and technical support system to conduct KFDA's policy and political affairs of the nation
5. Vitalization of communication to spread sympathy of safety

Systematization of risk communication and diversification of communication channel Expansion of a provision for information based on everyday life for each object
6. Strengthening cooperative system to establish safety basis

Expansion of a cooperation in establishing safety infrastructure for food and pharmaceuticals Raising international reliability of test or laboratory institutions Leading the global network for food and pharmaceuticals and enhancing mutual cooperation
Regional KFDA Reinforcement of abilities as a regional specialized institution and complete differentiation from local government
Conduct HACCP and GMP inspection and etc. Cooperation with local government for sanitary inspection and etc.
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History
August 2011

Headquarters, 1 Government, 5 Bureaus, 49 Sections, 1 Team, 1,460 Employees The National Tax Service transferred Liquor Safety Management responsibilities of to the KFDA. Adverse Effect inspection Team of the Nation Institute od Food and Drug Safety Evaluation was abolished and became Pharmaceutical Safety Information Team under Pharmaceutical Safety Bureau of the KFDA. Evaluation Science Division of the NIFDS changes their name to Pharmaceutical Standardization Research and Testing Division. The KFDA relocated to Osong Health Technology Administration Complex, Osong, ChungBuk during November. The KFDA Headquarters was previously comprised of 1 Officer, 5 Bureaus(5 Departments), 65 Divisions, but the composition was changed to 1 Officer, 5Bureaus(1 Officer and 4 Departments), 48 Divisions. Criminal Investigations Office, and Foreign Inspection Division were established National Institute of Toxicological Research was transformed into National Institute of Food and Drug Safety Evaluation(3 Departments, 18 Divisions > 3 Departments, 29 Divisions). I nnovation Planning Officer, and Laboratory Test Management Team were abolished, and creation and innovation Officer, and Laboratory Audit Team were newly formed instead. Headquarters were changed to bureaus, and the Team-based System became Division-based. The responsibility of treating and caring narcotic addicts was transferred to the ministry for Health, welfare and Family Affairs. pokesperson system was introduced for the advanced system for the press coverage, KFDA S also reinforced its staff and newly created 5 teams. Bureau for Risk Management, information Management Team, Customer Support Team, Novel Food Team, Clinical Management Team, Herbal Medicine Management Team, Cosmetics Evaluation Team, Biologics Management Team, Herbal Medicine Evaluation Team, Medical Devices Quality Management Team were founded. he organization of 2 Offices, 2 Bureaus, and 6 departments was restructured into 6 T Headquarters, and 4 Departments. Team-based system was introduced to all Divisions. and Bioproduct Technical Support Division.
2010

2009
2008
2007 2006
June
2005
The organization was restructured with the creation of Medical Devices Management Division, 2004
2003 2002
KFDA newly established Health Functional Food New Division, Health Functional Food Standardization Division, and Biologics Standardization Division along with the increase in staff. The National Center of Toxicological Research was reorganized to National institute of Toxicological Research Food and Drug Adminstration)
The Korea Food and Drug Safety Headquarter was raised to the status of adminstration(Korea February 1998
April
1996
Korea Food and drug Safety Headquarter and six Regional Offices were established. Four departments of the National Institute of Health were reorganized to six Safety Evaluation departments. The National Institute of public Health Safety Research was reorganized to National Center of Toxicological Research
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Vision / Mission / Aim
Promising Future 2020 for a safer/healthier life for the people

Vision Mission
To secure the highest level of public health by ensuring the safety of food, drugs, medical devices and cosmetics Prevention, action, support for the enhancement and protection of national healthcare, and securing of food and drug safety
Global Top 5 by 2020

Core values
Knowledge Foresight Desire & Innovation Association
Abundant expert knowledge View for the future Passion for the best Cooperation by through communication
Purpose
We protect
Sufficient Protection Smart Support Speedy Response
through the prevention, response and support for food and pharmaceutical safety.
national health
Sufficient prevention through elimination of risk factors in advance and enhancement of vulnerability
Smart support and cooperation for the establishment of the best food and pharmaceutical safety basis
Speedy response and appropriate risk management to reduce and recover accidents regarding food and pharmaceutical safety
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Chapter 01
Scope of Policy Support

01 Regulatory Reform to Enhance the Public Assurance, Industry Activity and the Nation's Status 02 Successful Relocation of Osong Health Technology Administration Complex 03 International Trade and Cooperation in Food and Drug 04 Reinforcement of Cooperation with Consumer Organization and Civil Affairs Administration Service 05 Policy Statistics to Manage Productions 06 Korea Internet Food and Drug Administration (KiFDA) 07 Promotion of R&D - Supporting the Safety of the Public
1. Regulatory Reform to Enhance the Public Assurance, Industry Activity and the Nation's Status 2. Successful Relocation of Osong Health Technology Administration Complex 3. International Trade and Cooperation in Food and Drug 4. Reinforcement of Cooperation with Consumer Organization and Civil Affairs Administration Service 5. Policy Statistics to Manage Productions 6. Korea Internet Food and Drug Administration (KiFDA) 7. Promotion of R&D - Supporting the Safety of the Public
CHapTEr 01
Scope of PoLicy sUpport
Once the amendment of the policy is complete, it is expected to promote the development of ready-to-eat food items while opening up ~5,600 jobs in instant food manufacturing and processing industry.
01
1) Outline
Regulatory Reform to Enhance the Public Assurance, Industry Activity and the Nation's Status
2) Supporting Globalization of Pharmaceutical Industry

The U.S. pharmaceutical market established the environment of encouraging the use of generic drugs in 2009 by health service reformation. Pharmaceutical companies of India and Israel are already expanding their market shares in the U.S. market. Therefore, domestic companies were demanded to enter the oversea markets including the U.S. It is essential for Korean pharmaceutical products to be applied with pre GMP assessment. However, Korea lacked information on GMP regulations for advanced medicine, GMP assessment experiences and domestic experts, impeding the introduction of domestic pharmaceuticals in foreign markets. Hence, the KFDA prepared Inspection Simulation Program for Companies desiring to Export Pharmaceuticals to Foreign Markets as a part of Method to Reinforce the Competitiveness of Pharmaceutical Industry, in order to solve the problems of pharmaceutical industries and promote the development of leading companies (March, 2010). Through this simulation with experienced experts, the companies were able to prepare themselves for real inspections.
1. Regulatory Reform Directions of 2010
In 2010, the KFDA planned regulatory reform projects with the private sector, as a private-government sector joint project, with the aim to assure the public, invigorate the industries and enhance the Nation's status. New projects were discovered through open meetings (Open Maru), the public opinions and policy forums, whereby the public and the industries raised their opinions. Also, 102 existing policies were chosen as regulatory reform projects, discovered by basic reviews.
2. Details of Regulatory Reform

1) I mprovement of Entry Regulation for Ready-to-Eat Food Manufacturing and Processing
Ready-to-eat food is usually cooked and sold in department stores or large malls. However, businesses were experiencing difficulties in the development of different food types as only 72 items were allowed in the regulations. Therefore, KFDA expanded 72 types to 105 in 2008, in response to sanitation improvement of manufacturers and processors, and promoted abolition of entry regulations for all kinds of food except bottled and canned food.
The KFDA also exempted the submission of GMP assessment data per item for pharmaceuticals of exporting purposes during their approval requests and allowed companies to follow the GMP regulation of the foreign country importing Korean products. As a result, about 30 Korean companies are exploring or in the progress of exporting their products to advanced countries like the U.S. and Europe. The combined export output is expected to be around 155,200 million won (raw materials: 25,000 million won, complete product: 130,200 million won).
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3) S upport for Prompt Commercialization (Approval and Evaluation) of Biopharmaceuticals such as Vaccines
There already existed a prompt approval system for preventive vaccine of infectious disease or pandemics. However, it required appropriate modifications to address the need raised by experiencing swine flu endemics. Biopharmaceuticals require advanced technology and a high-level of know-how for the establishment of production plants and commercialization (approval and evaluation). However, there are not enough experts and professional consulting organizations available to provide supports accordingly. Therefore, Article 36 of Regulation on Item Approval and Evaluation of Biopharmaceutical Products was segmented by epidemic phases, to specify data submission range, time and method, in an effort to systemize the standards of epidemic vaccines. The KFDA also functioned as the relevant companies partner or consultant to support efficient commercialization of biopharmaceuticals from initial development to approvals. Consequently, the scientific response system was prepared, and time wasted by companies was minimized through pre-consultation on new vaccine development or building/relocation of manufacturing plants.
As a result, the release period of newly developed medical devices were sped up to a maximum of 43 days, and cost of obtaining approvals was reduced.
Satisfaction research showed that 86.7% were satisfied with the amended regulation (October, 2010, conducted by the KFDA).
3. Regulatory Reform Assessment

Prime Minister's Office is annually evaluating the result and details of regulatory reform conducted by government agencies, to induce autonomic and active regulatory reform environment. The office evaluates such efforts in the position of consumers relevant to the policy, focusing on quality rather than quantity. The KFDA discovered 102 regulations (93%) out of registered regulations (110) to reform. In the process of discovering, the KFDA communicated with the public for active collection of opinions. The KFDA also reinforced the advertisement of regulatory reform by distributing the press release materials and briefing policy information. The administration utilized the internet media such as Blog and PCRM and conducted advertisements through the site visiting and meetings. As a result, 80 regulations (78.5%) were improved in 2010, and customer satisfaction increased from 68.2% in 2008 to 76.5% in 2010. The KFDA also received the honor of being awarded as an Excellent Department for regulatory reform for three years in a row.
4) E xpansion of Autonomic Management for Minor Change in Medical Devices

So far, the companies had to obtain KFDAs approval for minor modification made in medical devices, such as a change in design or color. Some companies distributed their products without receiving approvals even after changes were made, selling products that displayed differences when compared to their approved products. Therefore, the KFDA minimized the procedure so that companies can submit data once a year. The data described minor modifications that did not compromise the products safety (i.e. Changes in color or new placement of handles). This was done by studying regulations of advanced countries and collecting information from the industry. This increased the number of modification reporting from 8 product types in 2008 to 32 types in 2010.
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National standards were moved by specific refrigerant and freeze containers, keeping the highest (higher than 8) and lowest (lower than 2) temperature by automatic temperature recording devices. High risk pathogens were loaded after being packed into deep freezers and were tracked with GPS during its transportation.
02
1. Outline
Successful Relocation of Osong Health Technology Administration Complex
Transportable cages (sterilizing material) were used to move laboratory animals, while maintaining suitable temperatures and ventilating the vehicle. In case of frozen gametes, proper containers to maintain their frozen status were used. For items such as national standards and laboratory animals, the National Emergency Management, the National Police Agency and the Korea Highway Corporation gave assistance in safe relocation of precious cargoes. In November 2010, KTX Osong station and a new express bus route from Seoul to Osong opened to improve the residency condition. Also, shuttle buses were provided for commuters who have their residences around Osong. Finally, 91 official apartments were sold, and 21 were rented out to employees. Also, employees who purchased housings Chungbuk Province received tax exemptions.
The KFDA successfully completed its relocation project that began in November 2010 by March 2011, establishing a foot step to develop as an advanced bio industry cluster suitable for 21st century. The relocation project aimed to minimize the issues raised by the inability to work and secure facilities for convenient lifestyle through safe and efficient move of office and laboratory equipments.
2. Relocation Task Conditions

The relocation of the KFDA was based on the comprehensive plan that produced 20 task in 10 fields. This took in the consideration of the characteristics of items possessed by the administration and divided them accordingly to their specifications: office and laboratory equipments (general equipments), sensitive laboratory equipments, laboratory animals, national standards, narcotics and radioactive substances. For the pleasant working environment of the new administration complex, new furnitures and laboratory tables were installed, and laboratory facilities for food and drug were expanded. The relocation of general equipments was completed through the stages of packing, moving and reorganizing. Sensitive laboratory equipment moved by companies that specialize in laboratory equipment move, and used special vehicles. The validations of these equipments were conducted to set accurate test results.
3. New Era of the KFDA at Osong

With its relocation to Osong, the KFDA established a vision to secure the highest level of public health by ensuring food and drug safety. For that, it established three missions: to prevent and rapid response to food and drug related risks, and to establish a communication network with relevant partners. The KFDA will strive the best to protect the health of the Korean public. In the age of Osong, KFDA will make a greater effort to provide safety and health life for the nation on the foundation of advanced facilities, establishing the 3 key goals of perfect prevention, prompt response and optimal support and detailed strategies.
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2) FTA
Korea already agreed to the FTA with Chile, Singapore, EFTA, ASEAN, India, EU and Peru. Recently, Korea-India CEPA went through official negotiations (12 times), inter-
03
1. Outline
International Trade and Cooperation in Food and Drug
sessional negotiations (3 times) and vice-minister level talks (2 times) since 2006, and all of the issues reached the settlement on the 12th negotiation in September, 2008 and subsequently took an effect on January 1, 2010. EU is the second biggest trading partner for Korea after China. Korea-EU FTA is expected to be the catalyst for economic development, right after Korea-U.S. FTA, and it took an effect on July 1, 2011. Korea-Peru FTA is not expected to be highly effective for trade, but it took an effect on August, 2011 for bilateral resource cooperation and to provide an opportunity for Korean industry to enter Central and South American market. Out of all the FTA agreements, Korea-U.S. FTA in 2006 received the most concerns. Both Korea and the U.S. went through 8 negotiations after the first one in June 2006, and it reached the settlement on April 2, 2007. More negotiations were held until in February 10, 2011, where additional agreements were signed. The major content of the additional agreement that is closely related to the role of the KFDA is the extension of the transitional period from one and half year to three years, given for the mandatory implementation of the pharmaceutical approval and patent system. Korea-U.S. FTA ratified agreement is currently being reviewed by the National Assembly. Korea-U.S. FTA mainly covers the intellectual property rights of pharmaceutical
In the rapidly changing environment, food and drug safety management became one of most significant fields of government management that is directly related to the health of the nation. With the increase of import and export of food and medicine in the era of globalization, it is becoming essential that some degree of trade cooperation with international organizations and foreign governments must exist. Trade cooperation with international counterparts are being made in two principal types; WTO (World Trade Organization) as multinational cooperation and FTA (Free Trade Agreement) as bilateral cooperation.
2. International Trade
1) WTO
The KFDA directly and indirectly participates in the Agreement on the Application of Sanitary and Phytosanitary (SPS) and Technical Barriers to Trade (TBT) of the WTO, actively responding to pending issues related to Korean safety policy on food and drug, and negotiating with members if required to protect the health of the Korean public. The KFDA also notifies newly established or amended regulations and policy related to SPS and TBT to members through the WTO secretariat (34 cases in 2010). It is also providing responses to inquiries made by members while working as the inquiry point to analyze SPS/TBT notifications. These are subsequently delivered to the related organizations and private associations.
products, especially, in approval-patent scheme. If Korea permits the use of patent information by the generic medicine manufacturer, the KFDA is to notify the patent holder of such request if the patent period is still active. Also, the KFDA will prohibit sales of generics that did not gain the patent holders permission (while patent period is still active). The infringement of a patent is currently determined after the sales of generic medicine. However, once this scheme is implemented, the infringement is determined during the generic medicine approval procedure. When the Korea-U.S. FTA takes an effect, the Korean government will establish the method and procedure to maximize the balance of profit made between the patent holder and the generic company. Also, a cooperative foundation was prepared for cross recognition of Good Manufacturing Practice (GMP) and Good Laboratory Practice (Glop, and intergovernmental medicine - medical devices committee to discuss
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relevant issues and collaborative, as the result of the FTA. Korean government, in the short term, prepared the implementation method to minimize the possible damage on domestic companies. In the long run, the KFDA plans to promote the policy to enhance the international competitiveness of Korean pharmaceutical industries (Columbus project etc.). Currently, Korea is in the progress of negotiating FTA with 12 countries, including Australia and New Zealand, and in the progress of joint research on FTA with 23 countries, including China and Japan. Korea-China FTA is expected to create a relatively large ripple effect compered to current FTAs in progress. China has the largest amount of food and drug imports and exports as Koreas first trade partner and recently showed continuous economic growth. Korea opened the industry-government-academia for joint research with China in March 2007, and both trade ministers signed the MOU to close the joint research during May 2010. Also, both countries held the first pre-intergovernmental consultation in September 2010. As the Korea-China FTA negotiation approaches, the KFDA is discovering and analyzing the medical issues and preparing relevant strategies.
3. International Cooperation
Continuous exchange and cooperation with all the countries of the world and international organizations is particularly prominent in the fields of foods, drugs, cosmetics and medical devices. The KFDA is putting an effort on the protection and enhancement of the nations health by reinforcing the cooperative partnership with international organizations like the WTO and leading trade partners such as China, U.S. and EU. The KFDA is also promoting video-conferences with Health Sciences Authority (HSA) of Singapore, where both countries signed the MOU in June 2010, and promoted the establishment of conciliation with the countries in South Asia, such as Indonesia and Malaysia. Up until now, the KFDA signed the cooperation with State Food and Drug Administration (SFDA) of China for food, drug, cosmetic and medical equipment, General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) of China on food safety cooperation, Department of Health of Vietnam and Chile, Singapore HSA, the WHO for International Program on Chemical Safety Cooperation Agreement, Western Pacific Regional Office (WPRO) of the WHO, and Food Standards Australia and New Zealand (FSANZ). The Commissioner of the KFDA visited AQSIQ and SFDA in China in May 2011. At the meeting with AQSIA, both organizations reached an agreement to share organic information based on Japanese Nuclear Plant Incident of Fukusima that threats the safety of food. In the meeting with SFDA, the delegations reached an agreement to improve of cooperation for biosimilars and cosmetics, as well as the expansion of cooperation for medical devices and health functional food, establishing the foundation for Korean companies to enter the Chinese market. For the current condition of cooperation by countries, a total of 66 cooperation agreement were signed by August 2011. Out of the total, 51 (77%) contracts were with domestic organization, and 15 (23%) with foreign organizations.
3) Bilateral Trade Cooperation

While various trade issues are handled through with multinational mechanism of the WTO system, the necessity of bilateral cooperation also emerged as international trade increases. The U.S., China, EU and Japan take principal positions as Koreas trade partner in the field of food, drug, cosmetic and medical devices. Following the trend of international trade, the Korean government is discussing and responding to issues through Korea-U.S. Quarterly Trade Meeting (May 9, 2010), Korea-China Working-Level Trade Talks (July 2010), Korea-China Food Safety Cooperation Committee (October 2010), Korea-China Joint Economic Committee (December 2010), Korea-EU Joint Economic Committee (March 2010), Korea-Rusia Joint Economic Science Committee (August 2010) and Korea-Taiwan Joint Economic Committee (January 2011) and etc.
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Table 1-3-1 Current Cooperation Agreement Status

Overseas Dom -estic WHO WP -RO Ger -ma -ny 1 Ame -rica Ame Over Sin -rica Viet Aust -seas Total /EU/ Chile China -ga -nam -ralia sub -pore Ja total -pan 1 1 3 1 1 1 15 (23%) 66
1. R egulatory Reform to Enhance the Public Assurance, Industry Activity and the Nation's Status 2. S uccessful Relocation of Osong Health Technology Administration Complex 3. I nternational Trade and Cooperation in Food and Drug 4. Reinforcement of Cooperation with Consumer Organization and Civil Affairs Administration Service 5. Policy Statistics to Manage Productions 6. Korea Internet Food and Drug Administration (KiFDA) 7. Promotion of R&D - Supporting the Safety of the Public
EU
51 (77%)
04
Reinforcement of Cooperation with Consumer Organization and Civil Affairs Administration Service
The KFDA has dispatched 2 food and drug safety officers to Beijing and Qingdao of China and 1 officer to Washington D.C of U.S., as an effort to resolve the problems of entering China and U.S. market of foods, drugs, cosmetics and medical devices through the site support. Also, 4 officers were dispatched to the WHO and the CODEX Alimentarius to improve cooperation and raise Koreas status in international communities in regards to food and drug safety. The KFDA is also actively conducting the international collaborations by attending international meetings and conducting on-site inspections of foreign manufacturers and companies. In 2010, there were a total of 327 overseas trips recorded, and 5% of these trips required pre-authorization. Table 1-3-2 Overseas Work Trip Status
Preliminary examination is unnecessary Year Inter -national meeting 33 (10%) Cooper -ation meeting 40 (12%) on-site inspec -tion 159 (49%) Preliminary examination is necessary Training 22 (7%) Total Inspection, reward field trip, system, visit, data encourage acquisition -ment 17 (5%) 0 (0%) 327
1. Establishment of Cooperative Network with Consumer Organizations

1) MOU with Korea National Council of Consumer Organization and Korea Consumer Agency
With the consumers awareness on qualities with food consumption and purchases increasing, it is fair to state that consumer organizations influenced such changes in life style of consumers. Recently, consumer organizations are leading the protection of safety, right and interest of customers on foods and drugs as well as environment, medical services and youth issues. They are also expanding their boundaries as a spokesman and guard of the public. Its role is becoming wider as a check against government policies, advisors and partners for policy formation process. March 30, 2007, the KFDA signed the MOU with 10 consumer organizations, including the Korea National Council of Consumer Organization, for cooperation, based on Safety of Food and Drug. Major contents were on the cooperation of research and study, education and advertisement, information sharing to ensure the safety of food and drug.
Academic meeting 56 (17%)
2010
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Figure 1-4-1 Consumer Organizations Meeting (February 5, 2010)
Table 1-4-2 Current MOU Statistics

Name The agreement between KFDA and Korea national council of consumer organization on the establishment of a mutual task cooperation The agreement between KFDA and Korea consumer agency on the establishment of a mutual task cooperation Phone Fax 7744090 32731544 7749724 7524225 7365514 22799341 3253389 5783779 7986564 7748889 7017323 Date Ogranization Main content The cooperation on the investigationresearch field to enhance the safety of food and drugs, the cooperation on the public relations including trainings and campaigns, and the cooperation on the critical information sharing connected directly with the national health The elimination of spoiled-hazardous food and securing of drug safety, hosting of working-level quarterly meetings .
07. 3.30
10 Consumer groups including Korea national council of consumer organization
09. 6. 1
Korea consumer agency
Table 1-4-1 Current Condition of Consumer Organizations

Name of group The korea national council of consumer organization The green consumer solidarity The Korea YWCA alliance The Korea housewives club alliance The consumer citizen meeting The Korea central housewives class association The Korea consumer life institute The Korea consumer training institute The Korea consumer agency The Korea YMCA federation The head office of korea womens society Representative Address
Kim Jae Ok
701, Seoul YWCA hall, 1-1, Myeongdong1774-4050 ga, Joong-gu, Seoul 32737117 7749702~7 7524227~9 739-5530 22653627~8 325-3300
2) Reinforcement of Cooperation by Organizing Meetings with Consumer Organizations

After the conclusion of MOU with consumer organizations on June 15, 2007, the KFDA established a MOU consultative committee with consumer organizations (10 persons) and directors from each division of the KFDA, by holding an annual conference to discuss key issues. It also held a working-level consultation in both February and November, 2010 to improve the monitoring function, consumers rights to information and discuss regulatory reforms. The KFDA also periodically opened the meeting with the chairs of consumer organizations to improve communication and cooperation. Major details are specified below. Early 2010 (February 5): Appropriate regulation for Research & Development assessment that takes in consideration of properties of each consumer organizations, the elimination of false advertising and illegal sales, and the preparation of measures for Osong relocation project. Late 2010 (November 17): Pre-consultation of information release and plan for the expansion of nutrition labeling system and pre-cooked food. Research and study ran 13 projects (727 million won), including Proposal for Food Safety Policy based on Consumer Complaint and Attitude Survey, also planning to expand the safety researches on food, drug, medical devices and radiation.
Lee Deok Seung Kang Gyo Ja Kim Cheon Joo Kim Jae Ok Lee Yoon Ja
5-393, Hyochang-dong, Yongsan-gu, Seoul 1-2, Myeongdong1-ga, Joong-gu, Seoul 6th floor, Sangdong-building, 1-2, Namchang-dong, Joong-gu, Seoul 603, Pearson-building, 89-27, Sinmoonro2-ga, Jongro-gu, Seoul 19-3, Choonmuro5-ga, Joong-gu, Seoul
Kim Yeon Hwa
Hapjeong-dong, Mapo-gu, Seoul 301, Samhwa-building, Yangjae-dong, Seocho-gu, Seoul
Jeon Seong Ja Jeong Gwang Mo Nam Boo Weon Kim Gyeong In
579-0603
272-1, Hannam-dong, Yongsan-gu, Seoul 795-1042 1st floor, YMCA building, 117, Sogongdong, Joong-gu, Seoul 445-9, Hapjeong-dong, Mapo-gu, Seoul 754-7891 7017321~2
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Table 1-4-3 Current Condition of R&D in Consumer Organizations

(Unit: Case, Million won)
3) Civil Service and Professional Skill Consultation

All of the visits, fax and mailing for inquiries or applications for food, drug and medical devices approvals are reported to KiFDA system, which sends the document to the relevant division after the digital documentation. KiFDA system covers the supplementation, result input, search and delayed request. It has shown to be more effective than handling paper work and gratifies the curiosity of people by notifying progress through text messages. The system also
Class Cases Expenses
2007 12 595
2008 13 835
2009 12 654
2010 13 727
2. Civil Service KiFDA System

1) Outline
By the establishment of Food and Drug Services System, information service of the nation is improving with the availability of online services for approvals, applications and verifications. Recently, advances in life style are demanding higher quality services. Therefore, General Civil Service Office began to focus on the provision of prompt responses and high quality service.
directly provides the information requested through telephone inquiries. Lastly, it also established the honorary consultant system formed with retired officials by December, 2010 to provide expert advices. Table 1-4-4 Civil Services Statistics (2009 2010)
The new statistics list of 2011 2009 2010 National license 3,244 3,510 Standard and test method 8,599 6,648 Approval and registration 349,425 388,958 General civil affairs 16,763 23,097
(Unit: case)
Total 378,031 422,213
2) I nnovation of KiFDA System and Civil Service

KiFDA was selected as the 31st project of Food and Drug General Civil Service Office in October 2003, to promote Internet Strategic Planning. Therefore, the innovation of Civil Service started to take an effect, and the system was fully established by September 2006. Also, the office test-operated the KiFDA system for 3 months since September to identify and amend problems, and launched the system on January 1, 2007, and subsequently improving customer satisfaction.
3. Telephone and Online Counseling

1) Outline
The KFDAs Customer Center is where the KFDA representatives meet with the public face-to-face and engage in consultations through the telephone and internet. The number inquiries are annually growing, handling most of civil service work at the center. By this mean of seperation, other divisions of the KFDA can focus on their responsibilities in foods, drugs, cosmetics and medical devices. Consultants of the KFDA Customer Center are comprised as a permanent position, and provides the expert advices or information on legislation and notification that is difficult to be understood by the public. The center annually publishes the FAQ collection booklet. The importance of General Consultation Center is highlighted during a food or drug
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accident, such as the past melamine, talc and radiation incidents. It takes all the anger of the nation, delivers the apology of the KFDA and provides information of a response measure and future policy. The centers role will continue to grow as the bridge between the KFDA and nation. However, the satisfaction of connecting the KFDAs divisions with the public is all up to the operation of the consultation center. Figure 1-4-2 Homepage of General Consulation Center (http://call.kfda.go.kr)
3) Record of Civil Service

Service records slightly decreased after the introduction of identity verification in 2006, but it is also expected to increase by the continuous advertisement and improvement of capability and quality of consultation and supplementation of homepage FAQ. Record of General Counseling Center in 2010 is of following. Table 1-4-5 Record of General Counseling Center (2006 -2010)
Telephone consultation Class Sub total Food Medi -cine cosme -tics Medi -cal devi -ces Oth -ers* 8,267 Sub total Cyber consultation Food Medi -cine cosme -tics 3,617 4,152 6,710 8,304 7,683 Medi -cal devi -ces 1,503 1,614 1,766 1,649 1,730 Oth -ers* 316 206 218 478 467 Total
(Unit: case)
2006
95,788 43,136 26,094 18,291
16,626 11,190
112,414 134,365 162,329 194,410 192,908
2007 115,506 46,349 31,502 20,006 17,649 18,859 12,887 2008 136,856 68,756 36,432 23,062 2009 165,751 82,644 44,222 28,916 8,606 9,969 25,473 16,779 28,659 18,228
2010 167,190 87,938 40,284 27,958 11,010 25,718 15,838
*Others: inquiries for information of staff, department, phone number, location and how to use online service
2) Service Requests and Processes

The consultation system introduced the CTI (computer telephony integration) system and divided the department to each field of food (including health functional food), drug (including quasi-drugs, cosmetics and herbal medicine), medical equipment and other. Telephone services provide information through the call number: 1577-1255. The service hour is from 9am to 6pm, and closes on the weekend and holidays. For the questions that are difficult to be resolved by a consultant, Return Call system that calls back to the inquirer after discussion with the related department is in operation. In some cases, relevant departments may directly engage in the consultation. Online service operates same as telephone service but for 7 days, through the KFDA homepage - National Square - Online Consultation/FAQ.
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The number of food collection and tests, rejection rates, food poisonings reports and patient numbers are provided through E-Index Korea. Figure 1-5-1 Policy Statistics Publication for 2010
05
1. Outline
Policy Statistics to Manage Productions
According to the increased importance of the policy and clinical statistics, the International Trade and Statistics Office was installed on April 30, 2009, to handle all of statistics of the administration. It is largely divided policy and clinical statistics. Policy statistics provide the scientific foundation for the establishment, enforcement and evaluation of safety policy by verification, quality test and statistical analysis of food, drug and medical devices. Clinical statistics support the expansion of information sharing, pre-consultation for approval requests and professional statistical techniques, in order to vitalize the industry. The International Trade and Statistic Office also amended the Regulation for Statistics Performance in the KFDA (established regulation of KFDA #166, February 1, 2010) for systemic statistical workflow. This amendment established the Principle for Statistical Data Providing and Method (Article 15 and 16), obligated the consultation with Officer of Planning and Coordination when the statistics data is needed for a project (Article 11), defined education planning, statistics quality test plans, methods and procedures according to the higher legislation (Article 6 and 7), and established and operated statistic databases and service systems (Article 17 and 18).
2. Policy Statistics
After implementation of Policy Management System based on Statistics (enforcement ordinance of statistical Act 33, Presidential decree 20826, June 20, 2008), statistics are being actively used to establish and evaluate policies. To provide statistical information of the KFDAs performance and affairs for food, drug, health functional food, biopharmaceuticals, cosmetics and medical devices, the Office annually publishes Food and Drug Statistics Report. In 2010, the 12th report, composed with 206 items, was published. Statistics Collection of Industry and Sourcebook of Major Statisctics were also published in the same year. Information on national statistics, such as food and food additives output, imported food condition, collection and test result, are provided through the Korean Statistical Information Service (KOSIS).
Figure 1-5-2 Food-Drug Statistical Potal Site
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Figure 1-5-3 Self-Diagnostics of Statistics Quality
Field
The name of new statistics The current status on test animal production-import-sale The amount of used animal for health care-medical affairs The amount of discarded test animal in test animal facility The amount of discarded test animal in test animal supporter The record on risk information collection The record on annual professional/general drug production The local degree of complete drug self support The local degree of raw material drug self support The current status on complete drug corporations divided by scale The current status on raw material drug corporations divided by scale The current status on corporation divided by employment scale The current status on drug export corporation divided by countries The current status on drug import corporation divided by countries The current status on manufacturing-export-import of antibiotic drugs The information on proper usage of drugs The current status of locally developed new drug and improved new drug The current status on annual DMF notification The current status on biological equality test approval The current status on suitability assessment of biological equality test organization The number of anticancer drug test plan approval The current status on pharmaceutical affair monitoring agent The current status on safety information collection and process The current status on annual local drug monitoring center designation The current status on narcotics ingredients The record of biological drug manufacturing-import The top 10 manufacturing amount of cosmetics and quasi drugs The current status on clinical test approval for each items The local degree of medical device self support The current status on medical device GMP corporations divided by grade The current status on regional medical device GMP corporations The current status on medical device monitoring agent The current status on medical device honorary monitoring agent The current status on medical device civil affair process The current status on medical device technical document review-screening
Drugs (26)
Drugs (26)
The office established the foundation of food and drug statistics to promote the establishment of the KFDA Statistics Portal and development of Self-Diagnostics of Statistics Quality. It also analyzed the trend of related organizations and industry, reflected on survey requests, developed the policy statistics contents, discovered useful new policy statistics and adjusted and improved existing policy statistics to release 38 types of new statistics in 2011 Statistics Report. Meanwhile, statistics portal site will be established and launched by the late 2011. The check list was also developed to manage the quality of policy statistic, in terms of accuracy, relationships, accessibility, interpretation and consistency. In 2011, 21 types of statistics quality are to be managed by self-diagnostics and trust of policy statistics is expected to increase by resolving the improvement issues. For the major statistics, quality management conducted on an annual basis. Table 1-5-1 List of New Statistics for 2011
Field The name of new statistics The number of health functional food corporation The division of health functional food industry among the local industries Food (4) The monitoring on violation of health functional food manufacturers The monitoring on violation of health functional food distributors Medical device (8) Drugs (26)
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The office is supporting policy statistic analysis through consultations and surveys to improve the civil complaint made on the relocation project, and provided analysis data to policy establishment and evaluation in 2010. It also hosted a workshop and educational seminar with an expert to reinforce the capability of statistics management and production. The office is putting efforts to provide quality education for policy statistic the KFDA from 2011. Figure 1-5-4 Policy Statistic Education Workshop and Educational Resource
Figure 1-5-5 N umber of Clinical Statistics Application from 2009 to Early 2011
(Case) 140 120 100 80 60 40
2011 2010
20 0
Health functional food Biopharmaceuticals Crude Drugs Safety Medical Devices 2009 Pharmaceutical (Cate Products -gories)
The office is also publishing clinical statistics guidebook and holding the workshop to established the foundation for clinical statistics. One of the guidebooks published in 2010 is Data Management for Clinical Trials. This guidebook provides information in Clinical Data Management System, Case Record Form, Data Management Plan, DataBase Structure, Data Validation Specification, DataBase Quality Check, Archiving, DM Audit and etc. In 2011, Casebook of Clinical Test and Statistics for Medical Devices was published, based on the evaluation results from the clinic trials protocol and
3. Clinical Statistic
Clinical statistics of the International Trade and Statistic Officer is the statistical information that are used for clinical tests and collected information of food, drug and medical devices for their safety and efficacy. Every year, the number of test applications increase following the development of new test methods. A total of 242 cases of pre-consultation for approvals and professional statistical techniques were supported by the Office in 2010, which is 332% increase compared to the previous year. It shows the growing importance of clinical statistics. It is composed of 2 food cases, 1 biopharmaceuticals, 76 pharmaceuticals, 11 crude drugs, 119 medical devices and 32 on research protocol of safety information. The office support documents review of civil service as well as conducts research on the actual condition of clinical trials.
reports from 2010, in order to prevent often-made mistakes. This casebook covers 119 cases of 67 product items. The guide book for Statistical Consideration of Bridging Study and Casebook of Clinical Trials and Statistics for Medicine will be published in late 2011. The office held statistics workshop twice in 2010 to share and diffuse clinical statistics knowledge, and 140 persons including drug manufacturers, hospitals, clinical test centers and academia attended the workshop. The workshop of August covered the statistical considerations of clinical trials and the one on November covered Statistics of Clinical Trials for Medical Devices with the U.S. regulatory agency. The office is planning to hold a workshop for clinical statistics in late 2011, as well.
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Table 1-5-2 Application for Clinical Statistics in 2009 to Early 2011

Year Field Health functional food Biological drugs Drugs Herbal medicine Medical device
Investi -gation plan on safety infor -mation collection
Figure 1-5-7 2 010 Clinical Statistics Workshop

The part total
09 total 4 5 4 3 30 plan 2 5 1 3 21 result total report 2 3 9 2 1 76 11 119
10 plan 1 57 11 97 result total report 2 19 22 30 2 80
11 first half plan 22 53
result total report 8 2 27 6 6 110 16 229
plan 2 6 80 14 171
result report 4 30 2 58
Thus, the KFDA is doing its best to promote the importance of clinical statistics and share the knowledge by publishing guidebooks and holding the annual workshops, in order to establish the necessity and foundation of statistics for clinical trials and clinical statistics.
10
33
31
32
32
75
72
Annual total
56
41
15
242
197
45
144
107
37
442
345
97
Figure 1-5-6 2010-2011 Guidebooks for Clinical Statistics
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2. Performance
In 2003, the KFDA promoted the projects based on Information Strategic Planning (ISP) for KiFDA'. It covers 4 subjects: general service for food and drug, administration
06
Korea Internet Food and Drug Administration (KiFDA)
portal, information sharing, and safety information service for food and agricultural, marine, livestock products. The KFDA also established ITA/ISP in 2008, in order to promote effective informatization. Table 1-6-1 KiFDA Establishment Process
1. Background and Goal

As hazards in food and drug increase, single channel service was demanded by the public for the provision of relevant information. Therefore, the KFDA established a comprehensive information service channel in 2008, known as KiFDA. Based on KiFDA, the KFDA is planning to improve the convenience of online civil services, effectiveness of the administration, response capacity and information sharing with other organization. Figure 1-6-1 Objectives of IT Services
Name of business
Content The information system on food safety control
Year 04~05 05~06 06 07~08
Note 1st stage 2nd stage 3rd stage 4th stage
The establishment of food-drug general information service (KiFDA)
The information system on drug safety control The information system on medical device safety control Food safety portal
The establishment of KFDA information technology architecture (ITA) and informatization strategy plan (ISP) The establishment of fooddrug test-investigation national network (food area) for the sharing of test-investigation information The establishment of fooddrug test-investigation national network (drug area) for the sharing of test-investigation information The relocation of information system to Osong and establishment of informationcommunication network business
The establishment of information technology architecture (ITA) The definition of medium and long term informatization master plan and informatization strategic subject The food safety information network
08
Mission
Prevention, response and support for national health and safety of food and drug
09
Vision
1 Strategic Target
Preventive Risk Management System
Securing the highest level of national health by food and drug safety
2
Safety Management from Raw Material to Sales of Final Product
Supporting the Development of Competitive industry
Food and Drug Regulatory Reform to Promote Autonomy and Fairness
5
Vitalization of Communication for Safety
6
Reinforcement of Cooperation System
The drug safety information network
10
IT Vision
IT Strategic Target
Establishment of IT-KFDA for safety management of food and drug based on national trust
The relocation of information system to Osong The establishment of computing office and separation of network The enhancement of user convenient feature The reinforcement of document security and security management
10
Improvement of customer-focused administrative duties
Establishment of safety information channel for the public
Reinforcement of safety management capacity
Advancement of IT foundations
Improvement of IT capacity
2010 The advancement of KiFDA
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3. Prospect Plan
The KFDA is planning to establish the customer-focusedservice application system and improve and advance Food and Drug Safety Information Service. Figure 1-6-2 Prospect System Plans
IT Vision System
1. R egulatory Reform to Enhance the Public Assurance, Industry Activity and the Nation's Status 2. S uccessful Relocation of Osong Health Technology Administration Complex 3. I nternational Trade and Cooperation in Food and Drug 4. Reinforcement of Cooperation with Consumer Organization and Civil Affairs Administration Service 5. Policy Statistics to Manage Productions 6. Korea Internet Food and Drug Administration (KiFDA) 7. Promotion of R&D - Supporting the Safety of the Public
Establishment of advanced IT-KFDA for food and drug safety management
07
Modification of information organizing system
Advancement strategy of ITA Management system for IT investment performance Modification of information organizing system
Promotion of R&D - Supporting the Safety of the Public
IT Vision
Improvement of customer centered administrative system

Establishment of permission system basedon knowledge Establishment of easy and quick application system for civil service
Establishment Reinforcement of safety of safety information management channel

Establishment of advanced safety management system for food and drug
Advancement of IT base
Reinforcement of safety management
Recently, attention to well-being, introduction of the aging society and low birth rate is arising, and as a response, the public are striving for increased income and improved life style. The directions of governmental research and development (R&D) projects are to provide technical assistance of digital and network, promote convergence technology, such as Biotchnology (BT), Information Technology (IT), Nanotechnology (NT) and Environmental Technology (ET), and improve of the nations quality of life. The U.S. invested 21% (32,100 million dollar) to healthcare after national defense (56.9%), out of R&D budget of 2009. China and Japan are also concentrating on BT. However, Korean R&D budget for the KFDA is 0.4% (54,300 million won) out of total (13 trillion won).
IT Strategic target
Establishment Establishment of development of strategy plan plan for safety for KFDA information development portal
Establishment of development system for data quality
Advancement of IT infrastructure
Establishment of ITA advancement system
Knowledge management system for licensing support
Retrieval system for licensing support
Support system for screening and judgement
Expert POOL system
General complaint management system
Customer Relationship Management System
Introduction of KiFDA ll
Advancement of food and drug safety portal
Establishment of medicine safety portal
Establishment of medical equipment safety portal
Information sharing
Integrated control system for food and drug
Integrated database of imported food test
Management of food tracking
Safety management system for gene recombined food
Integrated information system for test analysis
Medicine statistics system
Integrated management system of human tissue
Distribution management system of narcotics
Medical equipment statistics system
Data quality management system
Establishment of data organizing system
Improvement of system availability
Improvement of system security
Improvement of network and PC security
IT actual project
4. Expected Effectiveness
It substantially improved the convenience of the service application, productivity and competitiveness of industry. Expected effectiveness are like the following: First, food safety system and effectiveness of Research Institute of Public Health & Environment and other food sanitation test organizations were improved by providing information of medicine and safety. Second, effectiveness of administrative service was enhanced by providing information to related department and officials. Third, safety management for medical equipment was improved through releasing evaluation result, tracking management of companys safety. Fourth, accuracy, speed, and transparency of administration were enhanced by the establishment of civil affairs administration portal. Fifth, customer centered food and drug safety culture was established by customizing the portal which provides the required information.
The KFDA is conducting researches on scientific safety management of food, drug and medical device to secure the safe and healthy life of the nation. The administration is also promoting product approvals to support prompt commercialization of BT, IT and NT products.
1. Expansion of R&D Budget for Scientific Safety Management of Food and Drug
In response to the rapid growth of food and drug safety management through the development in scientific technology, the KFDA is expanding its R&D scale to establish a new policy and scientific basis. It is showing annual growth of 4.7% since 2006. Main directions for R&D budget compilation are the following. First, improve
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productivity by promoting R&D projects. Second, introduce a flexible response system to reflect the policy in demand. Third, improve the cohesiveness of research to establish an operating base for large-scale project. Table 1-7-1 Financial Management of Major R&D Project in the Past 5 Years
(Unit: 100 million won, %)
Table 1-7-1 Changes Made in R&D Projects

Business system of 2009 (7 detail business, 27 small scale business) Safety control on food - Food safety control - Nutrition functional food safety control - National antibiotic resistance safety control - Childrens food safety control - Food risk analysis - Establishment of national monitoring system - Food safety control accroding to climate change Business system of 2010 (7 detail business, 32 small scale business) Safety control on food - Research on food safety control - Food poisoning safety control - Nutrition functional food safety control - National antibiotic resistance safety control - Childrens food safety control - Food safety control research according to climate change
Class Total Safety control on food Safety control on drug Safety control on biological drug
1)
2006 452.0 102.5. 62.8 37.5 35.1 184.1 28.0 2.0 -
2007 491.2 121.5 123.0 48.5 37.1 131.7 10.0 17.5 1.9 -
2008 519.0 139.3 122.5 49.1 37.2 131.3 20.0 17.6 2.0 -
2009 517.8 173.4 103.3 35.1 30.1 146.3 12.6 2.0 15.0
2010 543.1 175.1 155.1 37.8 103.0 49.5 7.6 15.0
Annual increase rate of average 4.7 14.3 25.4 100.0 1.9 13.5 net increase 100.0 39.6 -
Food-drug safety research-development
Safety control on medical device Basic research on safety control Basic research on toxicity of nano material2) Scientific approach of risk material safety control Research on international cooperation3) Research on political basis The management of researchdevelopment business
1) Consolidated to medicine safety management since 2010 2) Consolidated to Safety management research since 2009 3) Closed in 2009
Safety control on drug Safety control on drug - Research on drug safety control - Research on drug safety control -R esearch on cosmetics-quasi drugs safety - Research on cosmetics-quasi drugs safety control control - Research on active monitoring of risk case of - Herbal medicine safety control drug - Research on scientific herbal medicine - Research on international harmonization of assessment technique approval evaluation regulation - Research on advanced drug evaluation The best lab standard model development and - Research on active monitoring for side effect of - system establishment research drug - The research on biological drug safety control - The research on the assessment of vaccine usefulness - The research on high tech drug safety control - The research agency on evaluation of stem cell - The research on human body tissue transplantation material safety control - The research on the cooperation with international organization - The research on herbal medicine safety control - The research on herbal medicine assessment technique - The research on enhancement of herbal medicine evaluation system Biological drug safety control - The establishment of national standard form on biotechnological drug - The research on biological drug safety control - The research on biotechnological drug safety control - The research on the assessment base of high tech BT drug - The research on the assessment of vaccine usefulness - The research on the world health organization cooperation center Medical device-radiation safety control - Medical device safety control - Radiation safety control Integrated in (safety control on drug)
According to the structural reorganization of April 2009, R&D budget, which was divided by each subject, was consolidated as a unit project for maximized result and effective management. Also, Systematic Approach to Safety Management of Toxic Substance was distinctively organized for integrated management of toxic substances in the food and drug.
Medical device safety control - Medical device safety control - Radiation safety control - The research on U-health medical device assessment technique development
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Business system of 2009 (7 detail business, 27 small scale business) The research on safety control basis - The research on toxic material control - The research on human body effect of risk material - The research on high tech application basis - The research on nano material toxic basis
Business system of 2010 (7 detail business, 32 small scale business) The research on safety control basis - The research on toxic material control - The research on expectation assessment of drug safety - The research on the establishment of Korean clinical test-assessment basis - The research on high tech analysis technique basis - The research on nano material toxic basis - The research on the development of green toxicity assessment technique The scientific approach on risk material safety control - The research on confirmation of risk material exposure - The research on hazardous effect of risk material - The scientific approach of risk material hazard analysis
2. Establishment of Long Term Direction of R&D Projects

1) Operating KFDA R&D Planning Group
To establish the long term directions for R&D projects that are consumer and result focused, the KFDA established R&D Planning Group composed with various experts from academia and industry. The KFDA directed the group to set long term directions, organizing system and detailed projects for R&D. To correspond with the KFDAs R&D direction, existing organizing system of 32 detailed projects and 77 specific projects was reorganized to 7 detailed projects and 58 specific projects. 291 project proposals were prepared by the R&D planning group for 2011. The KFDA also confirmed the condition of KFDA Research and Development TRM that was established in 2008 and re-set the long term direction to Year 2017, based on the reorganized projects of 2011.
New detail business
The research on international cooperation Integrated partially in (safety control on drug) - The research on the international harmonization strategy of safety control system - The research on international cooperation with international organization The research-development of policy The research-development business management The research on political basis The research-development business management
3. Expansion of Research and Development Institute to Combine Projects

The KFDA promoted research based on the large scale operation to lessen the burden of initiating and reinforcing the research cohesiveness, improve project results, provide a wider responsibility for external researchers, and secure the continuity and autonomy.
Figure 1-7-1 Distribution R&D Budget in 2010
Policy Researches 756 million won (1.4%) Scientific Safety Management of Hazardous Substance 4,945 million won (9.1%)
R&D Projects 1,500 million won (2.7%)
By introducing research groups for of Safety management of childrens food and Advancement in medicine review and evaluation in 2008, and further projects on Safety management of residual pesticide, Systemic approach to herbal medicine evaluation technique, Drug observation and Drug metabolism base were initiated in 2009. In 2010, 5 more groups (7,550 million) for research on food, drugs, safety and hazard substance were created, expanding the total number of research groups to 10, with the R%D size of 16,190 million won, and taking up 30% (54,300 million won) of the total budget. The projects are progressing as below. Food safety management based on climatic
Researches on Safety Management 10,300 million won (19.0%)
Safety Management for Food 17,510 million won (32.2%)
Safety Management for Medical devices 3,780 million won (7.0%)
Safety Management for Drugs 15,516 million won (28.6%)
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changes project (2010~2014, 12,500 million won), Review and evaluation of stem cell medicine project (2010~2013, 5,500 million won), and Development of advanced toxic evaluation technique based of green growth and Nano safety evaluation projects (2010~2012, 3,800 million won). In addition, General exposure evaluation of hazard substance is in progress from 2010 to 2012, with 6,300 million won. Figure 1-7-2 Current Condition of Research Institutes
Safety management for childrens food (4,430 million won)
4. Providing Service to Assist Researchers

1) Publishing the Guidebook for Research Project and Development Expenses
The KFDA published the 2011 KFDA Research and Development Project Guidebook and the KFDA Research and Development Project Scheduler to introduce the purpose, direction, acception and performance of service projects to researchers. Also, Easy Guidebook for Service Research and Development Project was published to assist the external researchers who works for KFDA, to gain a better understanding of projects and properly spent expenses. It provides examples of the procedure, expense, calculation standard, over budget incidents and difference with other organizations for researchers to manage given budgets.
Food safety management
Safety management of residual pesticide (5,300 million won) Food safety management based on climatic changes (12,500 million won)
Advancement of medicinal review and evaluation (5,600 million won)
Medicine safety management
Drug observation (5,900 million won) Systemic approach to herbal material evaluation technique (9,840 million won) Review and evaluation of stem cell medicine (5,500 million won) Drug metabolism base (2,700 million won)
2). Introduction of Consignment Calculation of Serviced R&D Projects

The KFDA started consignment calculation since 2008 to resolving workload of research report reviews and expense calcuations, and improve the transparency of expense. It is now possible to concentrate on the review of the service research reports while enhancing the accuracy and transparency of expanses.
Research of safety management
Development of advanced toxic evaluation technique based on green growth (3,800 million won) Nano safety evaluation base (4,150 million won)
Systemic approach to hazard substance safety management 2007 2008 2009~
Integratedexposure assessment for safety management of hazard substance
2011
2012~
2014
The research institute is composed of large projects that are associated with medium and small projects. Hence, enhanced cooperation between projects is necessary to improve the productivity of researches. The promotion of research groups expected to maximize the productivity of research by minimizing trial and error, securing relationships between projects and establishing cooperating networks between project members, and expanding the collaborative channel between researcher and policy maker.
5. Awarding Researcher to Promote Active Participation of Researchers

The KFDA aimed to boost the confidence of researchers and establish the atmosphere that induces the researchers to participate actively in researches by giving awards. In 2010, 7 projects including Research of Advancement for Sanitary Aid were selected as best internal projects, and 5 projects including Establishment of Health Functional Food Export Guide out of serviced projects.
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Table 1-7-2 List of Outstanding Projects

Note The name of subject The research in the enhancement of quasi drugs Internal The technical support for the development of a dietary life calorie count environment The research on safety of the advanced preparation and validity assessment technology The research on OECD endocrine disrupting chemical search test method international verification Internal The research on health functional food technical support The development research on the dental burying materials and dental resin The new test method development research of the residual chemical among the food The establishment of health functional food exclusion country export guide The establishment of clinical test database construction for the clinical test evaluation technology security Service The meta-analysis research on the pharmacogenetic information utilization The research on the standard testing method development for the use environmental safety and performance of U-health care medical device The biodistribution assessment method development of the copy free adenovirus gene therapy agent Department(organization) in charge Cosmetics research team Nutrition policy department
evaluation. The administration also participates in the investigation and analysis of National Science & Technology Council, providing the result processed with other information from National Science & Technology Information Service (NTIS). The KFDA is also conducting self-evaluation according to plan and manual suggested by the Ministry of Strategy and Finance and receives an in-depth evaluation when requested.
High tech bio product department
1) Investigation and Analysis

In 2010, investigation and analysis covered 7 project units; food safety management (17,340 million won), medicine safety management (10,330 million won), medical devices and radiation safety management (3,009 million won), safety management foundation research (14,630 million won), policy research (196 million won), biopharmaceutical safety management (3,510 million won) and international cooperation research (1,260 million won).
The risk effect research team Health functional food standard department Medical device research department Chemical material department Ewha womens university Seoul national university The Istech Co. Ltd. The Korea instrument electricity and electronic test researcher
2) In-Depth Evaluation
Medicine safety management project received the in-depth evaluation and was subsequently selected for the provision of extra budget.
3) Tracking Evaluation
The purpose of tracking evaluation is to promote the continuedutilization of the R&D result. A total 567 projects were the subject of this evaluation in 2010.
First evaluation: 545 project of 2008 Second
Yonsei university
evaluation: 20 projects of 2007 that received Insufficient during the
6. Performance Management to Promote the Usefulness of Investment for Research and Development Project
Performance Management to Induce Investments in R&D Projects According to the properties of R&D projects that provide the scientific basis for safety management policy, the KFDA should focus on the policy utilization for planning, management and academic involvement. Also, it conducted self-management, analysis and tracking
evaluation in 2009 - Third evaluation: 2 projects of 2006 that received Insufficient during the evaluation of 2008 For those 12 projects that were evaluated to be Insufficient were demanded to submit the backup plans, and will receive the second tracking evaluation in 2011.
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Chapter 02
Risk Prevention
01 Food and Drug Risk Prevention and Dissemination of Safety Information 02 Integrated Control System of Risk Information and Reinforcement of Analysis Capability 03 Introduction of an Advanced Operation System in Foods and Drugs Test and Inspection Organizations
1. Food and Drug Risk Prevention and Dissemination of Safety Information 2. Integrated Control System of Risk Information and Reinforcement of Analysis Capability Introduction of an Advanced Operation System in Foods and Drugs Test and Inspection Organizations 3.
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Risk Prevention Area
1. Establishment of Risk Management System to Prevent Safety Incidents
01
Food and Drug Risk Prevention and Dissemination of Safety Information
The KFDA prepared an emergency response manual that outlines various action plans against possible emergency scenarios to prevent further spread of the crises and minimize public damage when faced by real food and drug safety emergencies. The manual identified 4 levels of emergency situations, defined as Attention (Blue), Caution (Yellow), Alert (Orange) and Serious (Red), and characterized appropriate directions according to each situation to minimize formality and unnecessary procedures, and establish an action plans that can be utilized at the scene of the accident. The KFDA is organizing regular mock trainings with the Office of the Prime Minister, Ministry of Health and Welfare, and the local governments. The training aims to develop smooth operational procedures to improve emergency response capability and establish a synergistic cooperation system with related departments based on the provided guideline. The KFDA have also organized a specific training program for staff members of the KFDA, and the City and Provincial Government. Figure 2-1-1 The Mock Training for Emergency Action (Food and Drug)
Foods and drugs are the critical resources in peoples lives, and securing their safety is the most significant factor in maintaining national health. In a modern world, owing to the development of science, new hazardous materials are being discovered in nature or from cooking and processing procedures. These materials have risks that are difficult to predict, and their treatment methods are equally complex. Therefore, the problem-solving approaches used in post-management, such as monitoring and inspection, are limited in the provision of proper direction of policies. Moreover, due to the globalization of food trade caused by the development in the mode of transportation, the increasing possibilities in the production and distribution of hazardous food and awareness of people on foods and drugs safety caused by the enhancement of living standards are resulting in greater expectations for highly reliable safety control system. Hence, rapid changes in the internal and external environment of food and drug safety, and the increasing concerns of the public. This required the KFDA to establish a preventive foods and drugs safety control system to prevent safety incidents of foods and drugs. To address these sociological requests, the KFDA has established a risk prevention policy bureau to prevent of food and drug safety incidents and take immediate actions upon their occurrence. The KFDA aims to prevent risk through examination and distribution of a wider range of risk information on domestic or foreign foods and drugs. It will also focus on the prevention and cooperative actions on their safety incidents, and provide risk information to related business operators. The KFDA also reinforces bi-directional communication among the consumers to prevent risk caused by inaccurate information.
2. Establishment of Food Control System through Anticipative Prevention

1) Preliminary Investigation for Early Prevention of Risk Factors
The KFDA collects food risk information from various sources including domestic
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and foreign governments and mass media. The KFDA also analyzes and evaluates the seriousness and urgency of the collected information and directs appropriate actions to secure the safety of domestic and imported food. Most importantly, the KFDA shall review intervention and control methods, such as prohibition of import or sale or distribution of food when an immediate action is required. This is to prevent food safety incidents in advance. In 2010, the KFDA performed an investigation on veterinary drugs, pesticide residues, food poisoning bacteria, heavy metals, food additives and substances produced from manufacturing processes in agricultural products, processed foods, and processed marine products. The investigation found 5 cases of abnormal pesticide residues from crown daisy and red-pepper leaf. The KFDA directed administrative actions, and suspended and seized the products to prevent further issues. Table 2-1-1 Current Preliminary Investigation Status
2005 Cases 916 2006 1,364 2007 1,453 2008 1,648 2009 474
(unit: case)
Table 2-1-2 Test Status for the Period of 2009 to 2010

Year 2009 2010 Number of Items 102 items 200 items Number of Cases 5,286 cases 9,930 cases Actual Condition of Improper Result 9 items 10 cases 13 items 27 cases
3) Reduction of Hazardous Substances Produced during Food Manufacturing Processes

The KFDA implements provisional measures, such as sales prohibition, and prepares management methods to eliminate or reduce relevant risk factors if there are potential concerns to human health, or there exists cases of safety incidents due to hazardous substances, The KFDA prevented the incident becoming a social issue through risk communications with consumers, media, academia and industries. It also encouraged risk reduction through on-site inspections and technical trainings. The KFDA also shared examples of successful risk reduction cases of an industry with the related partners for their active participation in risk reduction. In 2010, the KFDA pushed for two risk reductions - one is acrylamide in confectionaries that used potato as a main ingredient, and two, biogenic amine in fermented food. As a result, acrylamide reduction was achieved in the majority of confectionaries. Similarly, fermented food industries are actively participating in biogenic amine reduction. Overall two projects have shown successful results.
2010 834
2) T he Pickup Test on 500 Major Food Consumed in Mass by the Public

The KFDA developed a booklet to describe risk profiles in food based on food consumed in mass by the public between 2008 to 2010. The purpose was based on the need for a safety management of emerging risk materials that was either purposefully or unintentionally added or derived, and to establish preventive food safety management system for various novel foods. Based on this system, the KFDA is conducting pickup tests for 500 foods in total, of which, 100 foods were tested in 2009, 200 foods in 2010, and another 200 in 2011.
3. Risk Communication to Disseminate the Importance of Food and Drug Safety

1) Establishment and Promotion of a Risk Communication Strategy
As food and drug safety management is heavily based on scientific researches and professional expertise, the public communication showed various characteristics depending on individual understanding, knowledge, age and environment. Furthermore, specialists and the general publics view on food and drug risk can be
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quite distinct. Hence various consumer-focused communication efforts are needed to obtain the publics trust. It is equally critical to establish a concrete safety management system for foods and drugs. The KFDA has been reinforcing communications with the public through the establishment of a basic project on risk communication strategy in October 2010. The aims are to eliminate divergent views among the specialists and the general public, and gain public confidence in food and drugs safety management policies.
Table 2-1-3 The Subjects of The Open Forums of Foods and Drugs Safety in 2010
Date Subject The new standard of heavy metal (cadmium) in herbal medicines (scheme) The risk assessment to suggest standard of cadmium in herbal medicines The standard of cosmetics and improvable remedy of the test Understanding of pesticides The actual condition of domestic residual pesticide safety control and risk communication Understanding of radiation irradiation The actual condition of irradiated food control of industries
March 4th, 2010
May 25th, 2010 July 15th, 2010
2) The Open Forum on Foods and Drugs Safety to Communicate with the Public
With recent foods and drugs incidents/accidents becoming large scale and expectations on governments safety management level increasing, the need for risk communications of foods and drugs safety issues has increased too. The KFDA organized The Open Forum on Foods and Drugs Safety, to provide opportunities for communications and discussions on the policies between the interested parties such as consumers, producers, academia, and government to manage environmental changes efficiently. The KFDA hosted a total of 43 open forums between 2006 to 2010, in which 5,764 people participated. In 2010, four different forums with different themes, such as The Requirement of Improvement and Improvable Remedy of the Current Standard for Cadmium, The Standard on Cosmetics and Improvable Remedy of Tests, Understanding of Pesticide Residues, and The Views and Opinions of Specialists on the Safety of Irradiated Food were held. Figure 2-1-2 The Open Forums of Foods and Drugs Safety
August 13th, 2010
3) KFDA Open Day, Welcome to Osong! an Opportunity to Communicate Directly with the People
KFDA Open Day, welcome to Osong! is KFDAs visiting program organized every month since February, 2011, for the members of the general public, such as housewives, who are interested in foods and drug safety management. This program demonstrates and converses on how food and drug safety management is conducted. The visitors can experience the KFDAs responsibilities by visiting various laboratories and participating in experiments. The visitors are also given an opportunity to visit a related industry to experience how safety managements are being carried out in industrial settings. Figure 2-1-3 The Participants of KFDA Open Day, W-elcome to Osong!
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Figure 2-1-4 Participants Conducting an Experiments Prepared by the KFDA
Figure 2-1-5 KFDA Young Leaders in Food and Drug Safety Day Camp
4) T he Appointment of a KFDA Young Leaders in Food and Drug Safety to Communicate with the Next Generation
The proper understanding of foods and drugs by youths, who are still establishing their values in life, is particularly beneficial because it is directly connected with the health of the future society. The KFDA is operating a program called KFDA Young Leaders in Food and Drug Safety as a method to invigorate the communication with the next generation. The KFDA Young Leaders not only share food and drugs safety information in their perspective but also communicate to friends and family to lead changes in their perception. Young leaders of food and drug safety are divided into small teams, where they share their knowledge with friends, neighbors, and with people online through the promotion of creative advertising activities for 2 months. The KFDA will regularly provide information and update news even after the termination of their activity period as young leaders, for them to maintain future activities on their own. With this type of program as a start, the KFDA will continue to host different activities to inform future generations.
Figure 2-1-6 Young Leaders Participating in the Viral Test for Hands
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The online risk information collection and analysis of foreign and domestic food and drugs of 2010 is shown in [Table 2-2-1].
02
Integrated Control System of Risk Information and Reinforcement of Analysis Capability
Table 2-2-1 Status on On-Line Information Collection and Analysis of Domestic and Foreign Food & Drug Information
Year Number of food information Number of drug information 2003 1,776 2004 1,454 2005 2,912 2006 4,621 2007 5,224 2008 8,144 115 2009 15,541 6,916 2010 19,278 7,085
In 2010, the KFDA enhanced the collection and analysis of safety information through methods such as utilizing both online and offline information sources, to establish anticipative prevention system. The KFDA also focused in establishing rapid information exchange and distribution system. As examples of online information sources, the KFDA expanded its key word searches (63) and site searches (335) with the consideration of imported and rejected foods and drugs statistics. It also reinforced the information collection system by increasing the number of specialized editors to obtain information from international organizations, government authorities and news media. For offline information, the KFDA is utilizing foreign information reporters, dispatched workers in diplomatic offices, network between related organizations, and contact channels of foreign information sources.
Medicine, medical device and cosmetic information begin from December 9th, 2008
The collected information is shared with related KFDA departments or external organizations after the analysis and assessment processes. If required, the KFDA will take immediate response to the given information. In 2010, the KFDA gathered and analyzed 26,363 online information, and directed inspection of import or distribution processes, made changes in approvals of admission and sent out safety warning letter when deemed necessary. By supporting rapid risk prevention information collection and distribution of foods and drugs through comprehensive sharing system, the KFDA is also focusing on active communication with the public. Figure 2-2-2 R isk Information Flowchart
Figure 2-2-1 Risk Information Collection System (Online and Offline)
Online information
Offline information
Foreign information reporters International organizations Foreign/domestic government authorities Foreign/domestic consumer organization,
special organizations Foreign/domestic news medias
Diplomatic offices
(international students)
Consider magnitude of damage, import condition Analyze similar case in the past
Information Analysis
Information gathering
Online/Offline Speed, accuracy
Foreign/domestic network
(foreign offices of KFDA, welfare center) (organizations, companies)
Information collected by KFDA internally

(information gathered through works)
Integrated information
Discussion between related department Discussion on emergency and future measures
Remedial action
Information sharing
Rapid distribution of sharing target Discussion on future measures
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test/inspection organizations. The KFDA will authorize advanced national test ability and remove risk factors of test/inspection organizations.
03
Introduction of an Advanced Operation System in Foods and Drugs Test and Inspection Organizations
Figure 2-3-1 The Step by Step Distribution of Advanced Operation System for Test/Inspection Organization
1st step (2010)
Develop of models for food sector and conduct trial operations (8 organizations)
2nd step (2011)

Distribute to regional KFDA and city/provincial authority
3rd step (2012)

Distribute to private sanitary inspection organization
4th step (2013)

Distribution to private test/inspection organization of drug sector
1. Introduction of an Advanced Operation System in Foods and Drugs Test and Inspection Organizations
The test/inspection organization functions as a safety device for imported and distributed foods and drugs. Therefore, their objectivity and reliability are essential. In these days, the demands of the introduction of advanced test system are increasing to improve test reliability and international harmony of test/inspection organization due to the increasing possibilities of a trade dispute on test results of international trade goods caused by changing of international trade environment such as the FTA.
2) The Reinforcement of Domestic and Foreign Test/Inspection Organizations

To reinforce test ability of test/inspection organizations, the KFDA broadened the skill test, which has performed only for sanitary inspection organization of food area to other test organizations, such as drug areas, from 2010. The skill test is an evaluation of the accuracy and preciseness of the test which were provided with standard samples. The KFDA has plans in extending this test to both domestic and foreign test organizations by 2012. The KFDA is developing evaluation items and standards to introduce evaluation system, which test general operation system of test/inspection organizations. This system is an evaluation of the standardization of related documents and reagents, applicability of analytical devices, and competence of inspectors. This system will help in the establishment of advanced operation system, which can prevent common errors in test processes.
1) S upport and Promote Advanced Test/Inspection Organizations to Achieve International Standards

To develop advanced basis of the test system for test/inspection organization, the KFDA authorized a Laboratory Information Management System (LIMS) in health environment institute of city/province (16), and private sanitary inspection organization on food (57) in 2009. With this system, tracing test results was made possible. It also led to the standardization of test/inspection work processes and the establishment of LIMS at test/inspection organization of drug areas in 2010. The KFDA have plans in developing an advanced test/inspection operation system with international standards, such as those of WHO and CODEX, and have arrangements in introducing this system to the regional KFDA, health environment institutes of the city and province in 2011. This will expand to other organizations in step by step manner until 2013 to improve test quality and reliability of food and drug
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Chapter 03
Food
01 Preventive and Scientific Management Infrastructure of Food Hazards 02 Securing Health by Food and Nutrition Management 03 Preparing the Organic and Systematic Safety Management from Raw Material to Consumption 04 Establishment and Operation of Food Safety Information Center 05 Reorganizing Standards and Specification for Food, Food Additives, Equipment, Container and Packaging
1. Preventive and Scientific Management Infrastructure of Food Hazards 2. Securing Health by Food and Nutrition Management 3. Preparing the Organic and Systematic Safety Management from Raw Material to Consumption 4. Establishment and Operation of Food Safety Information Center 5. Reorganizing Standards and Specification for Food, Food Additives, Equipment, Container and Packaging
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Food
2) Expectations by Expanding HACCP System
01
Result of pre and post analysis of the companies that applied HACCP showed an increase in sales and a decrease in customer complaints. Table 3-1-1 Result of HACCP Application of Food Manufacturing and Processing Companies (100 Companies)
Item Average Differences Rate of Increase/ in Sale Decrease (+/-) 277 million won +63% 191 million won 10,847 million won 6,833 million won 267,103 ton 236,507 ton 22 place 478,759 ton 348,892 ton - 10 cases +32% +64% +71% +69% +88% +18% +91% +106% -74%
Preventive and Scientic Management Infrastructure of Food Hazards
1. Activation of Food Safety Management - Hazard Analysis Critical Control Point System (HACCP)
1) Concept and Necessity of HACCP System
Hazard Analysis Critical Control Point is a comprehensive food safety management system that confirms and analyzes all the potential hazards through managing raw materials and every procedure involved in food production. Figure 3-1-1 The Structure of HACCP
Total Total of Approved Item Total Financial Sales Total of Approved Statements Item Total Production Output Total of Approved Item Suppliers Condition of Total Sales Amount of Supplies Total of Approved Item Sanitary Index Number of Complaint Net Profits
cost efficiency analysis according to HACCP approval
As HACCP approved food range increase, food safety incidents will be reduced,
Analysis of potential physical, chemical, and biological hazards in raw materials and manufacturing processes
HA
Hazard Analysis
CCP
Critical Control Point
Focused management on manufacturing processes or phases to eliminate or reduce hazards to an acceptable level.
providing a better selection of safe food choices for consumers and assuring them in food safety.
3) Promotion of HACCP System

Codex Alimentarius Commission (CODEX) suggested the introduction of HACCP to its As incidents compromising food safety are increasing, the public is concerned. Therefore, the expansion of the systematic and preventive HACCP system is urgent to support safe food distribution for consumers, increase the level of sanitation management and strengthen international competitiveness of the food industry. member countries in 1993. Korea is operating this system based on the Food HACCP Regulation in the Food Sanitation Act from 1995, and legislation for Hazard Analysis & Critical Control Point-HACCP (KFDA notice) from 1996. The KFDA divided food types to mandatory application and optional application and is expanding the system annually. The mandatory application of HACCP was added to the Food Sanitation Act in 2002
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Food
to protect the national health by securing the safety of food of high risks or in high demand. In 2003, 6 food types were designated for mandatory application of HACCP (7 currently, after adding Cabbage Kimchi in December, 2006). In October 2005, HACCP regulation was amended to initiate phased introduction of mandatory HACCP from 2006 to 2010 for another 6 food types with the consideration of annual sales and employ numbers of food businesses (cabbage kimchi began in April 2008 and to be completed by 2014). Table 3-1-2 Implementation of Mandatory HACCP Approval, by Food Items
State 1 2 3 4 Criteria More than 2 billion won of annual sales and more 51 employees More than 500 million of annual sales and more than 21 employees More than 100 million of annual sales and more than 6 employees Less than 100 million or less than 5 employees Date of Implementation Date of Implementation for 6 Items for Cabbage Kimchi December 1, 2006 December 1, 2008 December 1, 2010 December 1, 2012 December 1, 2008 December 1, 2010 December 1, 2012 December 1, 2014
Table 3-1-3 HACCP Application by Item

Food Manufacturing and Processing Industry
(December 31, 2010 now, unit: place)
total
subtotal
Group Group Catering Catering Service General Non Service Selling Ice- Frozen Fish Retort sub- HeatFrozen Cabbage Products Food cream Marine Cake Pouch total Treated Products Kimchi Products Products Products Products Products Mandatory HACCP Approval 534 9 34 226 71 51 24 119 593 24 2
1,253
1,127
In 2010, the KFDA revised the HACCP standard to HACCP management standard for small companies to support easier approval and participation, and distributed the standardized management standard form for product types. Also, onsite technical assistants were increased by 22 (from 21 to 43) in order to provide HACCP support responsibilities (December 2010). In 2011, to expand participation for small companies, the KFDA will shorten the time taken to process of customer inquiries (60 to 40 days), reduce the required documents, allow the small company that requires optional approval to apply the Management Standard for Small Companies, and facilitate an easier approval for restaurant businesses. It is also planning to accomplish post management of HACCP approval, carrying out the routine observation on HACCP approved companies and the Food Sanitation Act violated companies. The KFDA is promoting various support activities for small and medium sized companies by establishing the HACCP Support Agency in the Korea Health Industry
Expansion of HACCP Application became a goal for the administration in 2008, and Comprehensive Measures for Food Safety of the Korean goverment also selected above goal as a main task. The KFDA is aiming to approve 4,000 food businesses by 2012. Up until now, the number of approved companies was significantly raised from 69 places in 2003 to 1,153 places in 2010. Figure 3-1-2 Number of HACCP Approved Company by Year
500 400 300 200 100 0
3 3 2 28 8 6 24 16 31 9 64 35 92 35 111 29 152 45 225 337 475 726
Unit: case
1,153
Development Institute since 2007. In 2010, the KFDA examined the condition of HACCP preparation, supervised techniques and began to train HACCP approved small and medium sized companies on efficient post management strategies. As the result, the average customer satisfaction of 2010 rose 83.9%. In 2011, the KFDA is planning to improve the support for small and medium sized companies by allowing them to receive the HACCP approval easily through technical support and expert consultations, and develop and distribute of HACCP management standards that can be used in optionally approval items.
Accumulated amount
Designation
1,200 1,000 800 600 400 200
78
122
146
263
456
1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 (On December 31, 2010, 1,153 places were approved (534 mandatory, 619 optional)
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Food
Figure 3-1-3 Strategy for HACCP Support Activity in 2010

Planning HACCP Promoting Company Promote HACCP
Increase awareness of HACCP and food safety knowledge Establishment of HACCP Plans to repair and remodel facilities, Carry out the plan, finalize for HACCP approval Hazard Analysis of raw material per manufacturing process Set management focus and limits Fill out management standard form HACCP Approval Application Disqualification Approval Completion
2. Real-Time Prevention System for Food Poisoning

1) Current Trend
Food poisoning in Korea has been decreasing in recent 5 years, but the number of reports and patients increased in 2010 compared to 2009. Table 3-1-4 Food Poisoning Cases by the Report and Patient Number
Year Reports Patient Number 2006 259 10,833 2007 510 9,686 2008 354 7,487 2009 228 5,999 2010 271 7,218
HACCP Support Agency

Website Management HACCP related content development, HACCP trainings and technology seminar Expert consultant for techniques Onsite technical trainings Visits to educational exhibitions Practical exercise on microbes Hazard analysis through proxy. Training on management standard form HACCP Director Trainings Modify HACCP System through onsite technical trainings Post Management by HACCP Operation Support
Preparation Stage
Approval Stage
Evaluation for Approval Management after HACCP Application and Approval
Decrease in 2009 due to the promotion of sanitation with swine flu endemic
Table 3-1-5 2010 Current Condition of Food Poisoning Outbreak

Microbes Clostri- ClostriCampy- EnteroVibrio Total Subt- Salmo- StaphyloBacillus dium dium lobacter pathogenic Other coccus parahaecereus perfrin- botuliotal nella jejuni aureus molyticus E. coli gens num
Food Safety Secured
Case
271
126
27 677
19 372 Virus
18 223
14 401
5 171 Chemicals 1 3
15 380 Natural Toxin 6 33
28 1,926
Patient 7,218 4,150 number
For a successful establishment of the HACCP, the consumer should prefer and choose HACCP approved items for food businesses to recognize such needs. Therefore, the KFDA is promoting the importance of HACCP to the public every year. In 2010, the KFDA diversified the advertising media to TV, subway advertisements, internet banners and HACCP proved company visiting programs. The HACCP awareness of consumers grew from 9.7% in 2005 to 30% in 2010, and the environment for voluntary HACCP application by food businesses is being established. The plan for 2011 is to reinforce TV and subway advertisements and diversify methods of advertising through budget increases.
Subtotal Case Patient number 33 2,002
Norovirus 31 1,994
Other 2 8
NonDetection 105 1,030
Immediately following the massive school food poisoning incident in 2006, patients of group catering service were temporarily decreased as sanitary monitoring was strengthened, but patient numbers are increasing again gradually
Patient rate of group catering service: 46.8% (2007) 48.3% (2008) 57.3% (2009) 58.0 % (2010) N umber of patients per single school incident: 54.5 (2007) 76.5 (2008) 69.6 (2009) 89.2(2010) N umber of food poisoning patients is 143 out of a million, similar to Japan. K orea: 201 (2007) 154 (2008) 123 (2009) 143 (2010) Japan: 263 (2007) 191 (2008) 159 (2009) 174 (2010)
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Food
According to the 2010 trend of food poisoning outbreak by month and location, 51% of outbreaks and 55% of patient occurred in the summer (June to September). Table 3-1-6 Food Poisoning by Month
Janu- FebruMarch April ary ary Cases Patients 9 142 17 430 15 364 20 893 May 15 201 June 29 1,908 July August 34 561 41 770 Septem- Octo- Novem- December ber ber ber 35 783 18 335 15 362 232 469
49.6% out of whole food poisoning incidents occurred in restaurants when sorted by locations, and 58.5% out of whole patients were found in group catering services. Table 3-1-7 Food Poisoning by Locations
Group Food Service Total Subtotal 53 4,189 79 School Direct 30 2,770 92 Consignment 8 620 78 Business 15 799 53 Restaurant Other*
Cases
271 7,218 27
133 1,704 13
85 1,325 16
Figure 3-1-4 Food Poisoning of 2010 by Month

(Cases) 70 60 50 40 30 20 10 0
9 142 17 15 364 20 15 201 1,908 561 770 783 29 18 15 362 469 34
Patients Patients Per Cases

Cases Patients (Patients) 2,000 1,500
* Other: Home, Instant food, Etc.
41 35 23
Salmonella poisoning by eggs in gimbap (seaweed rolled rice) and meat in precooked foods occurred most often (20 cases, 15%), and Norovirus poisoning was usually occurred at school and business. Figure 3-1-6 Food Poisoning at the Group Catering Service
(Case) 60 50 Consignment Direct
1,000 500 0
430
893
6 7 Month
335
10
11
12
Figure 3-1-5 Trend of Food Poisoning During Winter

(Cases) 120 100 80 60 40 20 0
1,634 1,281 1,180 528 1,041 50 80 53
40 Cases Patients (Patients) 2,000 1,500 1,000

49
Business 15 Consignment 7
30 20 10 0
School 38
7
Direct 31
22 2 High school Middle school
7 Primary School
45
500 0
2006
2007
2008 Year
2009
2010
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Food
Figure 3-1-7 Pathogens Causing School Food Poisoning

Norovirus 9 cases(35%) Enteropathogenic Escherichia coli 10 case(38%)
Figure 3-1-8 C urrent Condition of Enteropathogenic Escherichia Coli Outbreak per Month
(Cases) 10 9 8 7 6 5 4 3 2 1 0 Cases Patients (Patients) 900 800 700 600 500 400 300 200 100 0
Bacillus 1 case(4%)
Staphylococcus aureus 2 case(8%)
Campylobacter 3 cases(12%)
6 7 Month
10
11
12
Norovirus caused the most poisoning incidents, and the rest were like the following - Enteropathogenic Escherichia coli > Salmonella > Staphylococcus aureus > Vibrio Parahaemolyticus Table 3-1-8 The Foodborne Disease Break Status According to Causing Material in 2010
Pathogens Non-Detection Norovirus Enteropathogenic Escherichia coli Salmonella Staphylococcus aureus Vibrio Parahaemolyticus Bacillus Cereus Campylobacter jejuni Other virus Natural toxin Chemical Number of Cases 105 31 29 27 19 18 14 15 2 6 1 Rate of Cases 38.8 11.4 10.3 9.4 7.0 6.6 5.2 5.5 0.7 2.2 0.4 Number of patients 1,030 1,994 1,896 677 372 223 401 380 8 33 3 Rate of Patients 14.3 27.6 26.7 9.4 5.2 3.1 5.6 5.3 0.1 0.5 0.04
School 1,220 persons(64%)
Figure 3-1-9 Facilities that Caused Enteropathogenic Escherichia Coli Outbreak

Other 93 persons(3%) House 0 persons(0%) Business 250 persons(35%) Unknown 30 persons(2%) Restaurant 333 persons(18%)
Figure 3-1-10 Salmonella Outbreak per Month

(Cases) 10 9 8 7 6 5 4 3 2 1 0 Cases Patients (Patients) 250 200 150 100 50 1 2 3 4 5 6 7 Month 8 9 10 11 12 0
In summer, poisoning at the schools group food service caused by Enteropathogenic Escherichia coli was increased, and Salmonella poisoning was constant occuring throughout the year except for the winter season.
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Figure 3-1-11 2010 Facilities that Caused Salmonella Outbreak

Other 68 persons(9%) House 0 persons(0%) Business 124 persons(21%) Unknown 25 persons(4%)
Figure 3-1-13 Norovirus Poisoning in Japan

Number of patients 7000 6000 5000 4000 3000 2000 1000 0 1 2 3 4 5 6 7 Month 8 9 10 11 12 2009 2010 On average of 3 Years (06~08)
School 0 persons(0%)
Restaurant 460 persons(66%)
Norovirus has the characteristics to occur more frequently in winter, but 702 persons were poisoned in June, 2010 at schools, which is a different trend when compared to Japan. Figure 3-1-12 Norovirus Poisoning in Korea
Number of Patients 800 700 600 500 400 300 200 100 0 1 2 3 4 5 6 7 Month 8 9 10 11 12 2010 2009 On average of 3 Years (06~08)
2) Food Poisoning Prevention Management in 2010

(1) Operating Pan-Government Comprehensive Response to Food Poisoning
Pan-government comprehensive response organization to prevent food poisoning was installed after 2007, and the food poisoning preventive measures were prepared and operated by 32 organizations including central office group, local government and private operations. Its major focus was on the inspections of (2 times a year) for school and kindergarten cafeteria, distribution of the sanitation management guidelines, directed by the Ministry of Education, Science and Technology.
(2) Training and Inspections by Characteristics of Food Poisoning

It was possible to prevent food poisoning effectively by improving inspections and enhancing trainings prior to food poisoning outbreak. Inspections for the school and food supplier were implemented by Office of Edlucations in conjunction with local government during February and August. From inspected 5,646 businesses, 155 of these were found unsuitable and subsequently improved. In April and May, inspections at 454 youth training centers were carried out, and 7 were imposed with administrative actions for further improvement. During the summer, special inspections were implemented (57 out of 3,562 places) for food of concerns, such as Gimbap, sandwiches and box lunches, and during winter, inspections on 2,800 social welfare organizations were conducted.
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(3) Examination of Cafeteria Using Groundwater for Norovirus

As main assignment of Comprehensive Response for Food Safety (July, 2008), the KFDA is examining the condition of Norovirus for school and youth center cafeterias where groundwater is being used. The KFDA, local government, and service research organizations were involved in examining 976 cafeterias of school and youth centers twice a year, and 725 cafeterias of social welfare organizations and private residential schools. Norovirus was detected from the cafeterias of 11 schools, 5 social welfare organizations and one private residential school. The measures to prohibit the use of groundwater and provision of raw food, cleaning, disinfection of the water tank, and equipment improvement were applied to prevent possible food poisoning cases.
Table 3-1-9 2011 Schedule for Food Poisoning Prevention Project

Main Project Schedule Department (Organization)
1. Improvement of Instruction and Advertisement for Food Poisoning Prevention Instruction, Examination and Advertisement for Cafeterias of School and Kindergarten - Examination of Cafeteria of Schools (including Kindergartens) - Improvement of Old Cafeteria (continuously) - Expansion of Freezer for Preserved Foods Only Advertisement and Instruction for Cafeteria of Penitentiary - Broadcasting the Video for Food Poisoning Prevention - Instruction of Prevention Management for Correctional Institutions Workshop to Amend Prevention Management and Manual for Food Poisoning and Infectious Diseases Instruction, Examination and Advertisement for Cafeteria of Conscripted Police and Riot Police Prevention Check-up Service with Expert
At all times
Ministry of Education
At all times
Ministry of Justice
(4) Promotion and Education of Food Poisoning Prevention

In 2009, Swine Flu endemic showed a successful example of education and advertisement placed to prevent the spread of infections. A total of 34 trainings were conducted to educate 8,461 persons of school cafeterias, restaurants, cafeterias of social welfare organization, military camps and public officials, in the importance of food poisoning prevention. 30 supporters were appointed to promote Wash your hands campaigns (49 times, 11,800 persons) at primary schools and local festivals. Food poisoning prevention was advertised through TV, radio, buses and subways. The food poisoning prevention video Hand Washing, Cooking and Boiling was produced featuring actresses, and printed and distributed 2,500,000 stickers featuring Pororo the animation character to schools, restaurants and expressway rest areas. Also, an educational video Bboglebbogle, jiglejigle was created, and 26,000 copies were distributed to the city and provincial health centers and schools. Also, leaflets were distributed (500,000 copies) and posters (20,000 copies) to 1,756 health centers and gynecology hospitals. Other promotional materials for hand washing (10,000 leaflets, 3,000 posters and, 30,000 puzzles) were produced and used during Food Safety Day and local festivals.
At all times At all times At all times
Ministry of National Defense Police Agency Local Government
2. Establishment of Examination and Management System for Norovirus Improvement of Management for groundwater using Facilities and Inspecting for Pollution Source - Expansion of Groundwater Measurement Network (40 places in 2009 58 places in 2010) - Promotion of Small Water Supply Plant Improvement Project (657 places in 2010, government subsidies 573,000 million won) Improvement of Management System for Underground Norovirus - Examination of Norovirus Condition of Groundwater Pipes Examination and Improvement for Burial Site Foot-andMouth Disease Infected Animal - Examination for Influence from Burial Site of Foot-andMouth Disease and AI Infected Animals (23 places - 15 AI Burial Sites in 2008 - 2011 and 8 Foot-and-Mouth Disease Burial Sites in 2011) Norovirus Examination for 29 Beaches of South-west Coasts - Every Other Week of September, 2010 ~ April, 2011 Expansion of Prevention Facilities for Oyster Farm - Portable Toilet Dissemination and Examination for Incineration Toilet Instruction and Education of Fishing Industry for Prevention
At all times
Ministry of Environment
Yearly
Ministry for Food, Agriculture, Forestry and Fisheries
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Food
Main Project N orovirus Examination of Group Food Service Facilities using Groundwater - Group Food Service Facilities of School, Training Center and Social Welfare Organization - 18 cases out of 2,293 cases (Equipment Improvement and Sanitation Management of Detected Facilities) E stablishment of Examination System for Norovirus - Expansion of Water Sampling Equipment - Development of Examination Subject 3. Improvement of Safety Management for E xpansion of History Traceability System for Agricultural, Marine and Livestock Spot Examination of Food supplier
Schedule
Department (Organization)
At all times
KFDA
02
Securing Health by Food and Nutrition Management
At all times At all times
Ministry for Food, Agriculture, Forestry and Fisheries KFDA and Local Government
4. Support for Group Food Service Facility of Food Promotion Fund E xpansion of Food Service Facility Support - Freezer for Preserved Foods Only Support for Weak At all times Sanitation Facilities 5. Collection and Analysis of Food Poisoning Information and Share Operation of Alert Notification System Expansion of Publishing System for Violated Company At all times At all times
1. Management of Nutrition with Potential Risks: Sugar, Sodium and Trans Fat
1) Background
Obese society is expected to cost a total 1,800 billion won through direct and indirect medical expenses (1,100 billion won and 700 billion won, respectively). Childhood obesity is growing rapidly with the possibility that 40% of child obesity and 70% of teenager obesity would leave to adult obesity. Hence, it is necessary to establish the environment that protects children from obesity.
Local Government
KFDA and Local Government KFDA and Local Government
6. Improvement of Cause Investigation P rofessional Education Course for Food Poisoning Instructor(4 times, 109 persons) P rofessional Education for Examination - Setting up and Operation of Education for Examination At all times KFDA Course (February, May, September) I mprovement of Investigation by Gene Analysis. - Pulsed Field Gel Electrophoresis (PFGE) Analysis. Guideline Revision of Epidemiological Investigation for Water Born Infection. - Supporting the Prompt Field Investigation Centers for Disease Improvement Promotion for Cause Pathogen Investigation At all times Control and Prevention - 15,000 sets of Excrement Collecting Kit Distribution Improvement of Epidemiological Investigation Partys Capability 7. Improvement of Food Poisoning Prevention Education and Advertisement E ducation and Advertisement for Nation - Promoting Advertisement on TV(May~June) - 101 times May~June, KFDA on KBS, MBC, SBS 2011, Ongoing P revention Education Customized for Subject and Time Improvement of Hand Washing Project for Group Food Service Facilities - Expansion of Sink, Soap, Paper Towel and Hand Disinfectant - Water basin for Restaurants - Improvement of New Food Service Facility Ministry of Education, Ministry of Health and Welfare, And KFDA
2) Nutritional Value Labeling of Restaurants

The KFDA is promoting the policy to induce healthy food culture by enforcing nutritional value labeling for consumers to check the nutrition of processed foods and choose the right food.
(1) D evelopment and Distribution of Guideline and Q&As for Nutrition Labeling at Restaurants
According to implementation of Special Act for Safety Management of Childrens Diet, Regulation on Nutritionl Labeling and Method for Childrens Food was established. Therefore, Nutrition Labeling guideline and FAQ for Nutrition Labeling were also published to help the food industry. Many types of educational materials were developed to increase the publics awareness of nutritional labeling.
At all times
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Figure 3-2-1 Nutrition Labeling Guideline
Figure 3-2-3 I mplementation of Nutrition Labeling System at Jukjeon Rest Area
Figure 3-2-2 FAQ for Nutrition Labeling
Figure 3-2-4 S urvey of Awareness for Nutrition Labeling at Jukjeon Rest Area
(2) Pilot Project to Apply Nutrition Labeling at Family Restaurants

From December 29, 2010, VIPS, Bennigans and T.G.I.Friday's began labeling the content information of calories, sugar, sodium, protein and saturated fats. This system will undergo consumer surveys and expand accordingly.
(3) P romotion of Nutrition Labeling for Express Way Rest Areas (March 29, 2010)
Pilot project for the implementation of Nutrition Labeling System for Food at Express way rest areas The KFDA and Korea Highway Corporation designated Jukjeon Rest Area (Gyeongbu Expressway, Northbound Lane) as the Nutrition Labeling Specialized Rest Area, providing nutrition content information for 100 products. From surveying 3,000 visitors, 90% showed satisfaction, and 89% requested its expansion to the whole country. The KFDA is to continue further expansion and management.
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Figure 3-2-5 Result of the Survey of Awareness for Nutrition Labeling at the Rest Area
Degree of Satisfaction for Nutrition Labeling Normal(10%) Not Satisfied(0%) Not satisfied at all(0%) Expansion of Rest Area Nutrition Labeling Normal(5%) Not Necessary(1%) Uninterested(3%) Non-Response(2%) Really Necessary(32%)
(4) Preparing Nutrition Standards in Color and Shape

Colored and Shaped Standard (traffic light labeling) for nutrients was established to inform consumers, especially the children, the nutrition information (December 28, 2010). The colors used are from traffic lights (red, yellow and green) and in various shapes for efficient understanding of nutrition content. It is still being promoted to raise childrens awareness in the country.
3) Potentially Hazardous Nutrients (Sugar, Sodium and etc.) Reduction Project

Trans-fat free products increased from 36% in 2005 to 95% in 2010, and the product containing less than 0.2~0.5g of fat decreased 31% in 2007 to 5% in 2010. Due to the decrease of transfat, saturated fat containing products temporarily increased from 3.6g in 2005 to 4.0g in 2006, but it too decreased to 3.2g in December 2010 by the development in fat reduction technology. The information will be provided to the nation through the continuous observation of trans-fat and saturated-fat. Figure 3-2-7 Changes of Trans-fat Free Food in Snacks by Years (30g per Serving)
100%
85% 94% 95%
Satisfied (49%)
Very Satisfied(41%)
Necessary(57%)
Expansion of Voluntary Nutrition Labeling to All Major Rest Areas (July 16, 2010) All major rest areas of expressways are parts of the pilot project for the implementation of the nutrition labeling system. The KFDA and the Korea Highway Corporation is conducting the campaigns - signboard hanging ceremonies for 7 rest areas, teaching how to read the nutrition labels, and distributing food poisoning prevention materials and are planning to expand this system to 100 rest areas. Figure 3-2-6 Event of the Korean Highway Corporation (Yeoju Rest Area - Gangneung Bound Lane)
Less than 0.2g
80% 60%
45%
69%
40% 20% 0%
36% 21% 17% 24% 15%
31% 14% 1% 1% 6% 0% 5% 0%
0.2~0.5g 0.5~1g
2005
2006
2007
2008
2009
2010
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Table 3-2-1 Trans-Fat and Saturated-Fat in Domestic Processed-Food (30g per Serving)
Division
Trans fat
2) Establishment of Nutrition Evaluation and Management System

2010
Average
2005
Average
2006
Average
2007
Average
2008
Average
2009
Average
Strategic Management Gropu for National Nutrition, comprised of industry, government and academia, expanded and produced Nutrition Database for technical assistance of calorie counters and developing and distributing the Calculation Program for Nutrition Indication To provide nutrition service that the nation can refer to, Calorie Coordinator, a customized nutrition evaluation and management program for mobile technology and website was developed. The Calorie Coordinator was downloaded 103,531 times by December, 2010 and 76% of users were satisfied. Nutrition evaluation and management programs are being improved. Figure 3-2-8 Establishment of Calorie Counter Environment System
Range
Range
Range
Range
Range
Range
0.90.7 0.0~2.9 0.50.5 0.0~2.4 0.10.1 0.0~0.5 0.10.1 0.0~0.5 0.10.1 0.0~0.3 0.10.1 0.0~0.3 3.31.2 1.3~5.9 4.21.4 1.4~8.7 3.91.0 1.3~5.5 4.11.4 0.8~5.8 4.11.2 1.0~6.8 3.61.1 0.3~5.7 1.00.8 0.0~2.4 0.60.5 0.1~1.4 0.20.1 0.0~0.3 0.10.0 0.0~0.3 0.10.1 0.0~0.3 0.10.1 0.0~0.2 4.21.5 2.4~6.8 4.21.2 2.8~6.3 3.91.4 1.1~6.2 2.81.3 1.3~8.2 4.21.1 1.8~6.4 4.21.1 1.8~6.4 0.30.5 0.0~2.5 0.20.4 0.0~1.8 0.00.0 0.0~0.2 0.10.1 0.0~0.2 0.10.0 0.0~0.2 0.10.0 0.0~0.2 3.41.4 0.7~6.0 3.71.3 0.6~6.7 3.21.8 0.4~8.9 3.41.3 0.2~5.9 2.41.2 0.6~5.1 2.41.0 0.4~4.4 0.70.4 3.60.5 0.40.2 4.00.3 0.10.1 3.70.4 0.10.1 3.61.2 0.10.1 3.5 1.4 0.10.1 3.2 1.3
Biscuit
saturated fat Trans fat
Chocolate saturated
fat Trans fat
Snack
saturated fat Trans fat
Average saturated
fat
= standard deviation
The KFDA, related departments, industries, academia and associations held a conference to establish basic strategy for the reduction sodium intake. Also, a detailed plan was created to decrease sodium intake, composing the task force in 4 areas: food service, restaurant, processed product and education-advertisement. The KFDA is planning to promote the policy for reduction of sodium intake.
2. Improvement of Nutritional Evaluation System for the Nations Nutrition Management

1) Background
Due to the transition of life style where physical activities have decreased, and nutrition intake has increased, rate of obesity and chronic diseases are rising. According to the report of Ministry of Education, Science and Technology, extreme obesity rate increased from 0.8% in 2008 to 1.3% in 2010 and teenager (elementary, meddle, high school) obesity rate also increased from 11.2% in 2008 to 14.3% 2010. Children obesity rate keeps growing, as well as the adult obesity rate which has risen from 26% in 1998 to 32% in 2009. A detailed system for customized nutrition evaluation and management should be placed to prevent obesity and chronic disease.
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Figure 3-2-9 Diet Planning and Nutrition Evaluation Program
Figure 3-2-11 S atisfaction of Nutrition Service

Are you satisfied with Nutrition service? Normal(21%) Not Satisfied(3%) Not Satisfied at all(0%) No Response(0%) Very Satisfied(31%)
Figure 3-2-10 C alorie Coordinator, Smartphone Application
Satisfied(45%)
The survey targeted 7,000 students from middle and high school. The result showed that 10.5% of males, 14.8% of females had High Risk Eating Disorder. To prevent the nutritional unbalance of eating disorder, High Risk Eating Disorder Prevention Program was developed and tested in a middle school. The result of this project is to be analysed in 2011.
3. Improvement of Safety Management for Childrens Food

1) Condition and Prospect of Safety Management for Childrens Food
The KFDA recognized the necessity of comprehensive and systematic measure for food and announced the Comprehensive Measures for Safety in Childrens Food in February, 2007 and legislated the Special Act for Safety Management of Childrens Diet (a.k.a. Special Act for Children), (March, 2008). Based on this Act, enforcement decree and enforcement regulations (March, 2008) and nutritional contents standard for high calorie and subnutrition food (March, 2009) were produced. Special Act for Children provides the plan to establish the safe environment for childrens food, securing the safety of food and inducing children to choose healthy food. It also contains the plan to attract voluntary participation from industry.
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2) Designation and Management of Green Food Zone for Children

According to Special Act for Children, the head of local governments scheduled conferences with the superintendent of education and designate the school and the area within 200m radius as a Green Food Zone to protect childrens health, and place the manager for the Green Food Zone to observe and guide the restaurant on food hygiene. The head of local governments may designate the restaurants in the Green Food Zone where they do not sell high calorie and subnutrition foods to display Good Food logo. A total of 9,254 places were designated as the Green Food Zone and 1,037 restaurants were designated as outstanding restaurant by December, 2010. Table 3-2-2 The Management Status of Food Safety Protection Area
Division Number of School 11,389 Number of Designated School 10,451 Number of Green Food Zone 9,254 Number of Designate Restaurant 1,037 Number of Green Food Zone Manager 5,525 Number of the Restaurant in the Green Food Zone 44,236
Figure 3-2-12 High Calorie or Low Nutrition Food Differentiation Program
Figure 3-2-13 M obile and Smart Phone Version
Total
3) I mprovement of Distribution Environment for Childrens Favorite Food

The KFDA designated childrens favorite food that is usually high in calorie or do not contain sufficient nutrient to be prohibited from being provided at schools or designated restaurants (Article 8). Nutrition standards for this food is legislated by collecting the opinions of experts and concerned individuals. It can be differentiated by the nutritional labeling and other information. The KFDA developed the differentiation program (web based) in 2009 and published on its homepage "http://www.kfda.go.kr/ decision/decMain.html", and also produced and distributed promotional materials for children. In 2010, it developed an application for mobile and smart phones. Childrens food manufacturers started to work hard on improving the mixing proportions and processes to reduce the high calorie and subnutrition food. As the result, the rate of high calorie and low nutrition food from childrens favorite food decreased in 2009. In May 2010, the KFDA released a list of childrens favorite food with high calorie and low nutrition on its homepage for the first time, as means of securing the nations right to information and providing convenience to food sellers. Meanwhile, a quality certification system (Article14) was legislated to improve the
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children and parentss right of choice and induce the manufacturers to improve their product voluntarily. Thus, manufacturers can indicate the quality certification mark on the container or packaging if their products are confirmed to meet the regulation for food additives. 29 items of fruits and vegetables juice and ice cream received the quality certification by December, 2010.
6) Education and Advertisement of Childrens Diet Safety Management

Article 13 of Special Act for Children emphasizes the education and advertisement of food safety and nutrition, in order to let children practice the right diet and developing childrens capacity to choose proper food, especially in primary schools. Therefore, the KFDA has started pilot projects of nutrition education at the elementary school since 2008, and educated a total 16,792 students of 84 schools in 2010. It was found that nutrition knowledge was improved after the lecture on sugar, sodium and transfat, also, a tendency to reject the potentially hazardous nutrients were increased. It showed 80% satisfaction. From this positive response, diet knowledge, attitude, and behavior are expected to improve much more if the development of education methods and teaching materials are processed for repeated education. In addition, the KFDA made an effort to improve the awareness for Special Act for Children and emphasize the necessity of diet management through promotional material and poster, contest exhibit of slogans and posters for children and customers. The KFDA also developed the teaching material Nutrition and Diet for elementary schools, and planning to publish it to use in the class. Nutrition and Diet are developed in three versions; basic (1, 2 grades), intermediate (3, 4 grades) and advanced (5, 6 grades), after analyzing the whole subject of grade. Various methods to improve childrens capacity for select proper food will be developed by building a cooperative system for nutrition education with the student, teacher, parents and local society.
4) Calculation and Evaluation of Childrens Dietary Safety Index

Childrens Food Safety Index represents the degree of the policy fulfillment and improvement for environment: childrens food manufacturing, sales and supply. The KFDA notified the Standard of Investigation Items and Methods for Childrens Dietary Safety Index in 2009, and accordingly, a detailed index of diet safety, diet nutrition and diet recognition (3, 9 and 20 items, respectively). After the investigation and evaluation of the food safety index for 16 cities and provinces in 2009, the index of 21 big cities of more than 500,000 populations was investigated and evaluated in 2010, and food safety management quality of 123 cities and provinces of less than 500,000 populations will be investigated and evaluated in 2011.
5) Advertisement Restrictions for Childrens Favorite Food

Article 10 (Restriction on Advertisement) of Special Act for Children stipulates that, Companies that manufacturer, process, import, distribute or sell childrens favorite food cannot advertise that they are providing non-food products that can attract children to purchase their products through TV, radio and internet. Therefore, inspection of radio, TV (by local government, including satellite/cable TV) and internet (by the KFDA) advertisement were carried out. There has not been a single case of violation, and it is safety to conclude that the improvements are being exhibited. Advertisements from 5pm to 7pm were restricted in 2010, and programs for children are not allowed to have a commercial break. Programs for children (TV drama, quiz, game, education and information) are confirmed after consultation of broadcasting and advertising committees and childrens diet safety management committee.
7) Installation and Operation of Management Support Center for Childrens Food Catering Service
Along with the recent drop in birth rate and increase of double-income families, expectations have risen for food safety and nutrition management of childcare facilities. However, management for group food catering service has been insufficient, becoming one of the social issues. Therefore, Management Support Center for Childrens Food Service will be installed and operated in local governments, to support food safety and nutrition management of childcare facilities such as preschools and kindergarten,
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Food
where there is no obligation to employ an expert. The KFDA is planning to secure the government support budget to install Management Support Center for Childrens Food Service in the 6 local governments and 10 autonomous districts. As installation and operation of Management Support Center for Childrens Food Service expands, it is expected to improve sanitary condition of group food catering services and nutrition management of childcare facilities and kindergartens.
03
1) Outline
were exposed.
Preparing the Organic and Systematic Safety Management from Raw Material to Consumption
1. Safety Management Activity for Food Distribution
35,403 companies, where they handle holiday seasonal food, summer seasonal food, school cafeteria, food supplier and kimchi-making seasonal food, were investigated over 6 times by the joint enforcement in 2010, and companies in violation 1,535 (4.3%) Also, to collect and examine distributed food efficiently, collection and examination on sanitarily vulnerable areas (place) was expanded. 312 food groups, 219,910 items of agricultural, marine and livestock product (including health functional food) were collected and examined, and 1,645 items (0.7%) were confirmed as unsuitable. These items were subjected to real-time disclosure of information, prompt sales blockage, recalls, and discard. Automatic sales block system for unsuitable product (food) was developed with the cooperation between private (Distribution Company) and government agencies (Ministry of Knowledge Economy and the KFDA) and uses product codes to find incongruent food. So far, 24,092 places, including 17 large and middle sized distribution companies, stores and army welfare centers, autonomically participated, providing safe consumption conditions to 1,163 persons on a daily average and contributing to prevention through promptly blocking distribution and sales. Efficient examination and management were implemented by establishing the Regulation for the Scale, Investigation and Procedures of Foreign Substance (January 4, 2010) in order to have the companies report the customers dissatisfaction for
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foreign substances. In addition, post management system was switched to pre-management systems that stop the distribution and sales to evaluate and announce the result, as means of promptly blocking the incongruent products.
to the record of the past 9 years, the number of food products unsuitable for sale is decreasing.
(2) C ondition of Management for Special Products

From products with high market share, special management was carried out if their inspection results of the previous three years were poor. 65,488 products that received the high rejection rate were collected and examined, and 476 items (0.7%) were imposed of administrative actions.
2) Joint Inspections
The KFDA annually carry out joint inspections on the businesses, including manufactures, processors, distributors, transporters for food, with local government and the Ministry of Education. Table 3-3-1 History of Joint Investigations
Year 2010 2009 2008 Number of Company 35,403 9,714 26,574 Number of Caught Company 1,535 525 547 Rate of Violation (%) 4.3 5.4 2.1
5) Establishment of Private-Government Joint Monitoring System

(1) Expanded Operation of Consumer Observer for Food Sanitation
The Consumer Observer for Food Sanitation operates by inducing active participation of customers on food hygiene observation, exercising expert knowledges to operate regulations, and securing fairness, confidence and transparency to food sanitation inspections. In 2010, 164,480 observers participated in the improvement activities for +10 days a year.
3) O peration of Criminal Investigation Center to Eradicate of Illegal and Adulterated Food

In 2009, the Criminal Investigation Center was established by the special judicial police for crackdown on habitual and will-ful illegalities. It investigated a total of 765 cases (1,029 persons) and exposed 26 persons involved in illegal activities, taking the initiative in the elimination of Food Sanitation Act illegalities.
(2) Operation of Reward System for Incongruent Food Report

To improve the awareness of food sanitation management and reporting for incongruent food, a Reward System for Incongruent Food Report is in progress. In 2010, 8,050 reports were made 2,004 reports were given appropriate rewards.
6) Monitoring of False and Exaggerative Advertisement

False and exaggerated advertisement need to be controlled to protect consumers heath and prevent economic loss. Therefore, the KFDA and local governments are operating the monitoring system to control such advertisement on media, including internet, TV, newspaper and magazine. Expert monitoring agents are also hired to find these advertisements that deceive consumers in believing the product possesses pharmaceutical effects. They exposed 2,420 cases and imposed the administrative actions. The information on false and exaggerated advertisement and incident of violations is provided to consumers through the KFDAs homepage.
4) Product Sampling and Assessment in 2010

(1) Collection and Examination System
The KFDA shared its role with local governments, cities and provinces in collecting food samples of products with high incongruent rates or high market shares. 42 groups of food (219,910 items) were collected and examined and 1,645 items (0.7%) were deemed unsuitable. These products were recalled and discarded. Compared
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7) R ecall System of Hazardous Food and Disclosure of Information

(1) Collection of Dangerous Food
For a prompt response to negligent food accidents and damages of customers, the KFDA implemented various ways, such as sharing, utilizing, and releasing the information to the related organization, distributing company and customer, to block further distribution of concerned food products. For the prompt and systematic collection management of hazardous food, Guidelines for Hazardous Food Recall and emergency report systems were established in April, 2008. Also, SMS service and automatic sales block system were established. Furthermore, various regulations were amended, including rapid response to hazardous foods, to prohibit of sales, conduct food recalls and carry out safety inspections as post-management methods. Regulations and policies to secure the nations health will be continuously developed and amended. Figure 3-3-1 Information Sharing System for Hazardous Food
Rejected 16 cities and Food provinces, 6 regional KFDA offices, Examination Food sanitation results inspection organization Product information Automatic notification
(2) Automatic Sales Block System for Hazardous Food

Automatic sales block system for hazardous food is a cooperative system that links the urgent report system for hazardous food of the KFDA and distribution system of the Korea Chamber of Commerce & Industry (KCCI). Its pilot project began in 2009, and expanded to 24,029 stores of 19 distribution companies, providing safe purchase conditions for consumers. There are plans to expand the system to small and medium distribution companies to improve the safety network and distribution industry. Figure 3-3-2 F low Chart of Automatic Sales Block System
Urgent Report System for Hazardous Food
Connection System for Dangerous Products (Korea Net)
Distribution company
Suspension of Sales Update
POS of Each Store blocked at check-out
Prohibition of Sale
Food safety management organizations implement collection and examination and report hazardous food to the Urgent Report System of the KFDA. Then Korea Net of KCCI sends the information to the POS of its member company to stop the sales. Purchase blocking
Urgent report system for hazardous food
Automatic sales block system
(3) E stablishment and Operation of Customer Complaint Center for Food Safety
Hazardous Food Complaint Center is where customers reports are received and handled through 1399 Call. Its mail and visiting are linked to the homepages of local FDA, cities and provinces as a banner in March, 2008, improving the system for consumer reporting. In 2010, the system was improved to transfer the reported complaints through the information sharing and examination system, and took care of 7,697 cases.
SMS
Related organizations
Prompt recalls
TV subtitles
TV programs
Information disclosed to the customer and press
SMS
Stationery stores and small and medium merchants consumer organizations homepages of 1 6 cities and provinces.
Sales prohibition
8) Current Condition of Report for Foreign Substance

Website banners Information opening for local customers
On February 6, 2009, the Food Sanitation Act was amended to legislate it as an obligation that the company reports complaints to the local government if it receives the complaint from customers for foreign substances, in order to prevent the recurrence of foreign substance incidents and solve the trouble and distrust between
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customer and company. As means of preparing examination by stages of purchase, distribution and manufacturing, and improvement measures based on scientific examination for accurate causal analysis, detailed examination method and causal analysis for customers complaint were established in scientific measures. The KFDA shared standardized examination techniques and guidelines with the relevant agency and quickly resolved the company reports and customer complaints in 9,882 cases for foreign substance. It also resolved the public's concern by the improvement of manufacturing facilities and the prevention similar cases from occuring again.
2) Imported Food Conditions of 2010

In 2010, 293,988 items were imported from 129 different countries and top 5 countries, China, Japan and the U.S., take up 67.7% of the total imports. Table 3-3-2 Import Food Inspections in the Recent 5 Years
[Unit: case, thousand ton, million dollar, %]
Division Number of Inspections Weight (thousand ton)
2006 238,539 11,227 7,811 922 (0.39)
2007 270,163 11,799 8,449 1,448 (0.54)
2008 254,809 11,731 9,860 1,020 (0.40)
2009 255,341 11,301 8,434 1,229 (0.48)
2010 293,988 12,905 10,358 1,143 (0.39)
2. Establishment of Safety Management System for Imported Food

1) Imported Food Inspection
Import food inspections involve document inspections to confirm the products conformity towards standards for raw materials, food additives, labels and sensory inspections at the site of the inspection. The KFDA inspects the products that are imported for the first time or have histories of past rejections. These products are subjected to physiochemical examinations. All other import food goes through a random sample inspection, also for physiochemical examinations, for stringent inspection of imported food. Figure 3-3-3 Import Food Inspections
Cargo arrival Import declaration (document evaluation)
Sum (million dollar) Rejections (rejection rate)

Note: ( ) is unfit rate(%)
183,109 document inspection (62.3%), 25,974 sensory inspections (8.8%), 59,431 detailed inspections (20.2%) and 25,474 random sample inspections (8.7%) were carried out on import foods to protect Korean consumers.
3) Achievements in 2010
The KFDA conducted onsite inspections on 33 exporting companies in 7 difference countries, including China, Thailand and Vietnam, to secure their sanitary management. The KFDA registered foreign manufacturers of 15 import items (imported through 7 different domestic importers) as outstanding foreign manufacturers after conducting onsite inspections. The KFDA conducted an in-depth analysis for hazard information and import product rejection history of domestic and foreign government organizations, such as CODEX and FDA, to prohibit the importation of food with potential hazards (pork contaminated by animal drugs, ractopamine and salbutamol, and unapproved genetically modified
Document inspection
Sensory inspection
Detailed inspection
Random sample inspection
Return or discard
Rejected
Result
Conformed
Custom clear
rice). Safety Management Information System for Imported Food was published to provide inspection information in real time, promoting the advanced safety
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management for imported food. In addition, the KFDA and Korea Customs Service signed the MOU (memorandum of understanding) to improve the cooperative system with related organizations, conducting efficient management and simplification of customs clearance. The KFDA and Korea Customs Service also combined their database into a single program (UNIPASS, September, 2010)
3. Improvement of Safety Management for Alcohol

1) Outline
Alcohol safety was managed by National Tax Service since 1966. However, to respond actively to the changes of the alcohol market, the KFDA signed the MOU with National Tax Service (June 1, 2010). From then, the KFDA manages the alcohol safety and National Tax Service manage the tax revenue and licenses. Now, as the KFDA, the food safety expert organization manages safety, safety issues can be more professionally, synthetically and anticipatively managed, providing trust for the nation.
4) Plans for 2011

The KFDA is to push below regulatory improvements for effective management of import foods.
(1) P reparing the Foundation of Safe for Export at the Exporting Country
Onsite examination will be improved to confirm the sanitation condition of manufacturers of major exporters and the pre-confirmation based registration system will be implemented. MOU will be signed with exporters, to improve the safety management from the originating country.
2) Condition of Alcohol Consumption and Distribution

Annual alcohol consumption per person in Korea is 8.1 (2008), lower than the OECD average 9.3 (2008) and U.S., 8.7 (2007), but is higher than Japan 7.5 (2007). Domestic alcohol market in 2009 was 7 trillion and 358,900 million won (0.6% of the total GDP), and beer (49%, 3 trillion and 598,900 million won), Soju (39%, 2 trillion and 885,900 million won) and imported alcohol (wine, whiskey) cost 100 billion won, showing the increase. At the end of 2010, there are 1,551 alcohol manufacturing licenses, mainly rice wine, weak drinks and fruit drinks.
(2) O perating the Prompt Response System to Exchange International Safety Information
The KFDA will be actively collecting relevant information through monitoring major international information sources, oversea monitoring agents and foreign food safety organizations, to analyse and direct measures to secure the safety of imported food.
3) Necessity of Improvement of Alcohol Safety Management

Alcohol is usually regarded to be a safe drink because of the sterilizing effect, but contamination by foreign or toxic substances, such as mold or ethyl carbamate, is possible. Thus, anticipative and systematic safety management is essential.
(3) I mprovement of Safety Management at Customs

Rejection and hazard information of products from the past 5 years will be used for analysis, to improve the examination of toxic substances at customs. The importance was highlighted due to Japanese Nucelar Plant incident in 2011. Also, Importer Safety Securement System that includes Examination Order System that obligates the potential hazard product importer to submit ans examination result, and Compulsory Education System for incongruent product importer will be implemented.
4) Achievements
The meeting with alcohol companies and related organizations was held (July, 2010) after the signing of MOU, to explain the reason of transfers and prospects, and conducted safety management inspections and examination for 89 alcohol
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manufacturers (August, 2010) to impose corrective actions. A briefing session for foreign substance was held (September, 2010) with manufacturers of beer and Soju, made by dilution of spirit, to introduce and educate the foreign substance management. Also, safety management instructions and examination for 56 small beer manufacturers was provided and directed administrative actions for violated companies.
has provided 26,891 general information and 480 professional information, supporting the administrative actions of the KFDA.
(2) P romotion, Education, Operation of Food Safety Information Center

In order to build a foundation of management and distribution of the system and register the items, the Center implemented a food tracking management system and standard program, promoting and briefing session (26 times), standard program education (89 times), and on-site consulting (83 times), supporting the registration for 108 items.
5) Prospect Plan
The KFDA will establish the comprehensive plan for alcohol safety to conduct systematic safety management. Comprehensive plan for alcohol safety covers the technical assistance, including sanitation management for manufacturing and toxic substance and foreign material reduction, providing safe alcohol to customers and inducing the manufacturer to manufacture quality products.
3) Prospect Plans
(1) Collecting, Analyzing and Providing the Food Safety Information
The center is planning to promote the integrated management of information by operating a database and establishing an analysis system for customized information services, providing the latest (urgent) information, professional (advanced) information, hazardous food information and customer information, as required. It is also planning
4. Establishment and Operation of Food Safety Information Center

1) Establishment of Food Safety Information Center
Food Safety Information Center opened on July 16, 2009, in order to provide the food safety information to the KFDA and customer, build the foundation for food tracking management and conduct the task of related system promotion, education and operation by collecting and analyzing the international safety information.
to operate an information portal for food safety (Food Nara), to promote customer and consumption life centered information service.
(2) P romotion, Education and Operation of Food Tracking Management System

The center will improve its support to the industry through customized education programs and on-site consulting. It is also planning to invigorate the distribution of food tracking management systems by distributing the customized programs and building a system focusing on consumers.
2) Operation for Food Safety Information Center

(1) Collecting, Analyzing and Providing Food Safety Information
The center collects information from 265 sites of 47 countries and provides the daily intelligence and professional data to the KFDA. Since it was established (July 2009), it
(3) Establishment and Operation of Cooperation Network

The center is planning to promote cooperative activities to establish and operate the sharing and communication channel with customer organization and handle the crisis.
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5. Improvement of the Food Labeling System for Realization of Sovereignty of Customers

1) Food Labeling Regulation
Food labeling regulation was announced by the Commissioner of the KFDA (KFDA notification 2010-97, December 30, 2010) to promote sanitary treatment for food, provide the correct information for customers, and secure the fair trade, according to the Article 10 of Food Sanitation Act.
Supplementation of Raw Material Content Standards, When the Name is Used on the Name of the Product The products, which use the certain raw material as its name, have to label its content on the frontside. (i.e : Apple Juice (Apple 20%)) Prohibition of Using Word Flavor or Photos/Images of Indicated Food if the Product Contains Flavoring Agent If the product is flavored only by flavoring agent, it cannot use the picture or drawing of the real material. If it uses the flavor name, it should need to use the word flavor in the size of the product label, and indicate ~ Flavor Added or food flavoring agent added around the product label (example : strawberry flavor candy (synthesized strawberry flavor added) and cannot display a picture of a strawberry) Obligation of Labeling the Customer Complaint Call Number 1399 All of the products have to indicate Call 1399, for the unsanitary food for consumer convenience. Indication of Original Equipment Manufacturing (OEM) on Imported Food Packaging of OEM imported food is labeled in Korean, making customers misunderstand it as the Korean product. Therefore, the package is to indicate the country of origin and OEM size of at least 1/2 of the label.
2) Improvement
To minimize the burden of industry and wasted resources by frequent revision of labeling regulation, Combination Operating for Enforcement Date of Food Labeling Regulation released. Thus, regardless of the amendments made to labeling regulation, the enforcement date will be only once, on the same day every year. Also, regulations for glass kitchenware were introduced, and food additives labeling was simplified
3) Main Achievement
(1) 2007~2008
Reasonable Improvements to Set the Scope for Per Serving for Nutrition Labels The necessity to establish the scope of single serve was discussed, and regulations were revised to indicate the serving amount per 1 time for the products that are packed all together and packed separately. The product that is packed for one person needs to label its whole net contents per single serve. Obligation of to Label Packaging Dates for Ingle-packed Frozen Food The packaging date labeling for individual frozen desserts became mandatory.
(2) Latest Improvement

Preparing the Voluntary Display of Nutrition Labeling The previous nutrition labeling was on the back side, making it difficult for consumers to identify it. Now it can be shown on the front side, providing the correct nutrition information to customers. The standard form on the front side is to prevent the misunderstanding and confusion of customer. Specification of Per Serving Standard in Nutrition Labeling The amount per serving for pizza was established, and amount per serving for beverage was revised. The mount per serving for carbonated drinks was revised, and the standard amount that was combined was divided individually.
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Food
Revision of Gum Base Labeling Regulation Food additives (coloring and preservatives) other than gum base were obligated to be indicated. Only 12 additives of gum can be indicated as gum base, and coloring and antioxidant for gum base have to be indicated separately, providing more accurate information. Improvement of Cautionary Labels Glass cooking utensils have to be divided and indicated for its use with direct fire, oven, microwave, and boiling. Any other glass utensils need to indicate that it is not to be used with fire. Improvement of Labeling Standards for Frozen Bread and Frozen Salted Fish Recently, regulation and standard for frozen bread and salted fish were partially revised. If the frozen bread and salted fish products are released to the market after defrosting, it must indicate the packaging date, thawed date, expiration date and storage methods.
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Establishment and Operation of Food Safety Information Center
1. Safety Management of Health Functional Food

1) Condition and Prospect of Health Functional Food
Demand for health functional food is growing internationally, due to the increase of chronic diseases and the aging society that is accompanied by increased average life span. Health functional food in Korea was 3.75% of international market in 2008, but it is expected to increase to 7.2% by 2013
4) Expected Effectiveness
The KFDA has been making efforts to improve the system as Customer Centered Oriented Food Labeling System. Combination Operation for Enforcement Date of Food Labeling Regulation was implemented to improve burdens and inconveniences experienced by consumers and industries
Figure 3-4-1 Expectation of Growth Rate for Health Functional Food - NBJ, 2007.
15,000 15%
10,000 10% 5,000 7%
0 1999 2000 2001 2002 2007 2008 2009 2010 2011 2012 2013 2014
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Table 3-4-1 Euromonitor, 2008

Country USA Japan China Germany South Korea Italy Rest of World Total 2008 Sales 25,754,240,000 15,457,654,647 9,328,590,582 4,024,632,049 2,767,813,854 2,550,006,522 13,958,062,346 73,841,000,000 Share 34.88% 20.93% 12.63% 5.45% 3.75% 3.45% 18.90% 100.00% Sales 28,265,280,000 14,703,154,080 12,858,625,322 4,150,221,986 6,111,794,236 3,259,192,496 18,902,587,827 88,250,855,947 2013 Share 33.29% 17.31% 15.14% 4.89% 7.19% 3.84% 22.26% 100.00%
Therefore, it is necessary to support the consumers with better health functional food through improvement of education and promotion for the nation and professionalism of health functional food experts. The KFDA will prepare the various policies and systems to establish a great condition for production and provide quality health functional food to secure the products safety and functionality.
Size of the health functional food market: 210 billion dollar (2002) to 3,77 billion dollar (2007)
2) Advancement of Management and Evaluation for Standards and Regulations of Health Functional Food
(1) Health Functional Food Certification System
Health functional food is the product that is produced and processed with the substances that contain helpful effects for humans. Functional means that it provides nutrition control for human to improve the health. Any raw materials or substances (functional substances) with functionality are largely divided into two categories. First category substances are stipulated by Article 14.1 and 15.1 of the Health Functional Food Act, where the Commissioner of the KFDA may set standards, specification or raw materials and substances for the purpose of selling products. Second category substances are all the exceptions of the first category. These are stipulated by Article 14.1 and 15.1 of Health Functional Food Act, where information on the substances standard, specification, safety and efficacy are individually certified after data is received from the business operator, to grant a certificate. According to Article 2 of Regulation of Certification for the Material and Standard of Health, a substance that is individually certified, is functional substance for the used in health functional food manufacturing and is processed material of animal, plant or microorganism or its extract, refined material, synthetic material and compounds, Certification Procedure Article 12 and 13 of Regulation of Certification for Materials and Standards of Health Functional Food, stipulates the scope, method to document, content and requirement
But, according to the OECD healthdata 2010, Korean medical expenses per person is growing most quickly in OECD members, requiring relevant management regulations. The increased rate of medical expenses per person for U.S and Canada is 5.9%, and Korea is 11.6%. Also, the increased rate of medicine expenses of Korea is 11.3%, which is second fastest country in OECD. Figure 3-4-2 Korean Medical Expenses per Person are Growing Fastest in OECD Member
Increased rate of medical expenses per person for OECD members
annual average(%) OECD U.S. United Kingdom Spain Poland Nether lands Slovakia Korea Ireland Finland Canada Belgium Australia
0 1 2 3 4
Medical expenses rate in GDP is lower than OECD average

medical expenses per person ($)
6.7 5.9 7.2 7.7 8.1 7.0 11.5 11.6 9.9 6.1 5.9 5.7 4.3
5 6 7 8 9 10 11 12
8,000 7,000 6,000 5,000 4,000 3,000 2,000 1,000 0

Portugal Czech Republic Poland Switzerland France Germany Austria Canada United States
Iceland
Danmark
Spain Finland South Korea
GDP per person ($)
of data required for submission, to receive individual certification, Required information is the following.
10,000 15,000 20,000 25,000 30,000 35,000 40,000 45,000 50,000
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Summary of the whole information Origin, details of development, condition of domestic and foreign certification and use Manufacturing method and related information Information of materials property Regulation, test method and the test result of functional substance Regulation, test method of toxic substance Information for safety Information for function Caution for the amount of intake and related information Confirming information for that substance is same or different with medicine Figure 3-4-3 Procedure of Certification and Evaluation for Functional Substance
Application Filling in an application form Processing Organization Receipt Examination Certification Notification Payment On-site investigation Consultaion
Expansion of Evaluation Organization Regulations and test results of functional and toxic substances were needed to be certified by the Korean organization, even though it is certified by a foreign organization, creating financial burdens and inconveniences for manufacturers. Therefore, it was revised so certification from foreign organizations can be used as long as it is confirmed by the Commissioner of the KFDA (KFDA notification 2010-76, October 29, 2010).
(2) C urrent Condition of Individual Certification

Individually certified substances increased 24% in 2010 compare to the previous year (278 346). The certification of Reducing body fat and improving joint and bone was diversified to health for menopause of woman, eye, skin, urinary tract, memory and digestive functions. For 6 years since the regulation was enforced in 2006, 346 functional substances were certified, showing annual growth rate of 15%. In 2010, Ginkgo leaf extract (11 items) and Milk Thistle extract (10 items) were the most frequently certified items. Green tea extract (3 items), Lutein (3 items), Pomegranate extract (2 items), locust tree fruit extract (2 items) and Saw Palmetto fruit extract (2 items) were next. Memory (12 items) and liver health (12 items) are the most certified
Functional Level for Health Functional Food Function of health functional food was classified to Function for reducing the incident of disease and Bioactive function. Bioactive function is classified again to 3 levels, where the levels are also divided into Helpful for ~, Might be helpful for ~ and Might be helpful for ~ but practical test is insufficient. The detailed classification is to provide the certified function information for consumers. These detailed regulations will be enforced by September 1, 2011.
items, and blood circulation (11 items), body fat (7 items), menopause (5items), regulation of blood glucose (5 items) and immune system (4 items) were next. In the recent 7 years, Garcinia cambogia extract (25 items), Conjugated linoleic acid (22 items), Milk Thistle extract (20 items) were the most certified items, and Coenzyme Q10 (19 items), Saw Palmetto fruit extract (16 items), Soybean isoflavone (14 items), Lutein compound (13 items) and Ginkgo leaf extract(12 items) were next. Table 3-4-3 Number of Functional Substances Certified
(Unit : item, The late of 2010)
Table 3-4-2 Functional Level for Certification

Functional Level Function for reducing the incident of disease Bioactive function level 1 Bioactive function level 2 Bioactive function level 3 Detail Help to reduce the incident of ~ disease Helpful for ~ Might be helpful for ~ Might be helpful for ~ but practical test is insufficient
Year Number of certified substance New functional substance
2004 9 9
2005 23 4
2006 29 2
2007 36 4
2008 84 1
2009 97 1
2010 68 2
Total 346 24
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Figure 3-4-4 Number of Individually Certified Substances (Item) by Year

Sodium hyaluronate Hovenia dulcis fruit extract Pyrophosphatase Creatine Soybean ferment extract Calcium-PGA Lyprinol Isomaltooligosaccharide Bilberry extract Rosehip powder Green tea extract Phosphatidylserine Evening Primrose Extract Active hexose correlated compound L-theanine Banaba extract Hematococcus pluvialis extract Dimethylsulfone (MSM) Gingko leaf extract Lutein compound Soybean isoflavone Saw Palmetto fruit extract Coenzyme Q10 Milk Thistle extract Conjugated linoleic acid Garcinia cambogia extract
Year
3 3 3 3 3 3 3 3 3 3 3 4 4 4 5 5 6 8 13 14 13 16 19
Only those that have more than 3 products
Number of the substance
New functional substance 25. France coast pine bark extract 26. Policosanol 27. AHCC 28. Phosphatidylserine 29. Rosehip powder 30. Guava leaf extracts 31. Plant stanol esters 32. Broccoli sprouts powder 33. Katsuobushi Oligopeptide 34. Hovenia dulcis fruit extract 35. Raffinose 36. Angelica mixed extract 37. Glucosamine 38. Casein hydrolyzate 39. Green mate extract 40. Enterococcus faecalis heating treatment powder 41. Corni extracts 42. Olive leaf extracts 43. Evening Primrose Extract 44. Coenzyme Q10 45. L-Glutamine 46. Saw Palmetto fruit extracts 47. Linseed 48. Bilberry extracts 49. Distilled pine needle concentrate 50. Soybean ferment extract 51. Creatine 52. Lutein mixed compound 53. Sardine refined fish-oil 54. Pine bark extracts mixed compound 55. Haematococcus pluvialis extract 56. Agar powder 57. Beefsteak plant mixed extract 58. Germanium yeast 59. Casein phosphopeptide 60. Albumin 61. Garcina cambogia bark extract 62. Soybean germ extract mixed compound 63. Melon extracts 64. Red ginseng concentrate 65. Sodium Hyaluronate 66. Soybean isoflavone 67. AHCC 68. Keumsa phellinus linteus mushroom 69. Amorphophallus konjac extracts 70. L-Theanine 71. DHA concentrated oil 72. Tomato extracts 73. Green tea extract 74. Zeaxanthin extracts 75. Red ginseng, Torilis japonica, corni mixed extract 76. Fructooligosaccharide 77. Saw Palmetto fruit extract mixed compound 78. L-Glutamic Acid GABA-containing powder 79. Fatty acid compound 80. Hydrolyzed guar gum 81. Polygala tenuifolia root powder extract 82. Coffee manno Oligosaccharide 83. Guava leaf extract mixed compound 84. Puer tea extracts 85. Gooseberry extract 86. Red yeast rice 87. Medium chain Fatty acids oil 88. Vegetable oil Diacylglyceride 89. Milk thistle extract 90. Hop extracts 91. Probiotics VSL#3 92. Refined squid oil 93. Nopal extract 94.Lactulose powder 95. Coleus forskohlii root extract 96. Natto yeast 97. Calcium-PGA 98. Rice bran extract 99. Lyophilized silkworm powder 100. Silver Berry extracts 101. Rhodiola Rosea extracts 102. Ginseng eleutherococcus mixed extract 103. Xylo-oligosaccharide 104. Sesame leaf extracts 105. Cranberry extracts powder 106. Nori-peptides 107. Lithospermum extracts powder 108. Salmon peptide 109. Bees wax alcohol 110. Artichoke extracts 111. Cynanchum wilfordii compound extract 112. Fermented amino acid compound 113. Ginkgo leaf extracts 114. Pomegranate extract/concentrate 115. Lemon balm extracts compound powder 116. Golden-thread Collagen enzyme decomposed peptide 117. Scholar Tree fruit extract 118. Acerola concentrates compound 119. Morus alba extract compound 120. Onion extract 121. Tienchi seng extract compound 122. Perilla frutescens extract 123. L-Carnitine tartrates 124. Green tea extract/Theanine compound 125. Rhynchosia volubilis peptide complex 126. Chlorella
2006
20
2007
16
2008
17
2009
20 22 25
30
10
15
20
25
30
Table 3-4-4 C urrent Condition of Individually Certificated Substance by Year

Year Number of the substance 9 New functional substance 1. Sardine peptide 2. Xylitol 3. Theanine mixed extracts 4. Aloe extracts 5. Aloe mixed extract 6. Angelica gigas Nakai root extract 7. Hibiscus mixed extract 8. Lyprinol 9. Indigestible maltodextrin 10. Bamboo grass extracts 11. Black mushroom 12. Banaba extract 13. Scutellaria laterifolia mixed extract 14. Spirulina 15. Pyrophosphatase 16. Dimethylsulfone (MSM) 17. N-acetylglucosamine 18. Grape seed extract 19. Isomaltooligosaccharide 20. Conjugated linoleic acid (free fatty acid) 21. Conjugated linoleic acid (Glycerides) 22. Pinitol 23. Soy oligosaccharide 24. Rhodiola rosea mixed extract
2010
19
2004
(3) Management of Unusable Substance

As the customers interest for health functional food is growing, the industry is developing various functional substances using plants crude medicine. There are lots of substances that contain strong toxins, or pharmacological effects, but industries
2005
14
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occasionally develop them. Therefore, strong bioactive substances with potential hazards and strong pharmaco-health functional food substance that is not suitable for health and welfare, are managed. Unusable Substance for Health Functional Food was established and notified to prevent the development by the industry, securing the safety. Ephedra, yohimbine and erectile dysfunction medicines are some of them, and it is annually evaluated and added to the list. 15 more plants, including Euphorbia kansui and Tussilago farfara, were added in April, 2010, and 4 more plants, including absinth, were added in 2011, listing a total of 111 types. Recently, Regulation of Unusable substance for health functional food was integrated to Regulation and standard for health functional food.
Table 3-4-5 Current Condition of Health Functional Food Industry

(December, 2010 / unit: place)
Year 2006 2007 2008 2009 2010 10/09 (%)
Total 49,203 50,255 58,570 63,458 73,177 15.3
Health functional food manufacture Sub Total vocational 337 345 356 385 401 4.2 313 319 328 349 364 4.3 Venture 24 26 28 36 37 2.8
Importer 1,955 2,201 2,395 2,528 2,764 9.3
Health functional food distributor Sub total General Distribution 46,911 47,709 55,819 60,545 70,012 15.6 45,833 46,649 54,538 59,234 68,554 15.7 1,078 1,060 1,281 1,311 1,458 11.2
3) Management of Manufacture and Distribution for Health Functional Food

(1) General Condition
Outline As society is becoming older and diseases are becoming westernized the nations medical expenses are consistently increasing. Therefore, the financial burdens of medical expenses are growing bigger, becoming a financial issue for the government. The KFDA is also putting multilateral efforts on establishing safe manufacture and distribution, and reducing the burden of medical expenses by regulation improvement and support. Industry Condition Korean industry of health functional food in December, 2010 is shown below. 401 manufacturers, 2,764 importers, 68,554 general sellers and 1,458 distributors showed 4.2%, 9.3% and 15.6% growth, respectively. Also, reported health functional food were 2,880 items, increased by 21% compare to 2009 (2,378 items).
Manufacturing Condition From the analysis of the production records of health functional food manufacturing, the output entered 1 trillion won market in 2010, as the first time since the introduction in 2004. It also increased 11% compared with the previous year. Among the health functional foods, the output of red ginseng product was 58,170 million won, 55% of total. Next on the list was: individually certified product (11,290 million won, 11%), vitamin and mineral product (9.910 million won, 9%), aloe product (5,840 million won, 5%) and omega-3 fatty acids product (3,480 million won, 3%). Table 3-4-6 Manufacturing Condition of Functional Food Industry (December 31, 2010)
Division 2006 2007 2008 2009 2010
10/09 (%) 1) 1$ = 1,156 won
Total output (million won) 7,008 7,235 8,031 9,598 10,671 11.2
Domestic Output (million won) 6,637 6,888 7,516 9,184 10,211 11.2 Production (ton) 10,933 10,239 12,990 19,293 48,846 153.2
Export Output (million won) 371 346 514 415 4601) 10.8 Production (ton) 667 339 697 592 367 38
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Figure 3-4-5 Condition of Market by Item

Propolis extract 97 / 1% Dietary fiber 117 / 1% Garcinia cambogia extract 208 / 2% Probiotics 317 / 3% Ginseng 341 / 3% Omega-3 fatty acid oil 348 / 3% Aloe 584 / 5% Vitamin and minerals 991 / 9% Individually certified products 1,129 / 11%
(10.12.31 now)
At the end of 2010, there are 148 GMP certified companies, 40% of 364 specialized manufacturers. Table 3-4-7 Annual Condition of GMP Certified Company
Total 148 2005 27 2066 41 2007 18 2008 15
(December 31, 2010 / unit : place)
2009 24
2010 23
Red ginseng 5,817 / 55%
Detail information of GMP certified companies is available on Health Functional Food Information Hompage (http//:hfoodi.kfda.go.kr) - GMP/GMS/Advertisement GMP
(4) Establishment and Support for Quality Foundation of Manufacture

Figure 3-4-6 Good Manufacturing Practice Mark
(5) Establishment of Health Distribution Order

Improvement of Post Management As the consumption for health functional food expands by the increase of income level, desire for health, growth of the aged population, various products are developed and distributed. Now, the active safety management has become essential. Also, as the scientific techniques advance, and environment changes, health hazardous factors such as residual pesticide, sexual function enhancers, blood pressure reinforcing agents, antibiotics, heavy metal and new toxic substance are growing. The KFDA is putting efforts on securing the safety of regulations and standards, and prevention of injury from exaggerative advertisement, through efficient
Introduction and Operation of Good Manufacturing Practice (GMP) The KFDA is operating Good Manufacturing practice (GMP) for the systematic, organized management of health functional food, to secure product safety and improve the quality. Companies can commission consignment production from the venture manufacturer for health functional food and specialized distributors, and indicate the GMP mark when it obtains the GMP certification. Vitalization Support for GMP System For GMP vitalization of small and medium companies, 14 companies received funding for GMP consulting (70% government expense, 30% own expense) in 2010.
post management including collection, examination and monitoring. Sales of illegal health functional food through the internet are creating market confusion and consumer injury. The KFDA requested the blocking of foreign illegal websites to Korea Communications Standards Commission in order to secure the healthy distribution order. The KFDA is planning to improve the collection, examination and monitoring, and keep the cooperating system with related organizations to provide better distribution order.
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Improvement of Labeling Regulation Figure 3-4-7 Health Functional Food Mark
Table 3-4-8 Annual Result of Deliberation for Function Labeling and Advertisement
Total Year Total 2004 2005 2006 2007 2008 2009 2,435 2,711 1,968 1,716 1,698 2,438 3,022 Result Printed media Broadcast media Number of deliber -ation 44 51 50 49 52 50 50
(Unit:item)
Appro Appro Appro Appro Inappro Appro Inappro Appro Inappro -priate -priate -priate Total Total -priate -priate -priate -priate -priate -priate in in in 444 506 518 587 452 511 699 1,813 2,068 1,420 1,073 1,180 1,768 2,123 178 137 30 56 66 159 200 2,116 2,310 1,735 1,513 1,490 2,161 2,717 430 478 490 558 438 483 665 1,566 1,745 1,227 912 1,003 1,558 1,898 120 87 18 43 49 120 154 319 401 233 203 208 277 305 14 28 28 29 14 28 34 247 323 193 161 177 210 225 58 50 12 13 17 39 46
The KFDA is operating Labeling Regulation of Health Functional Food in order to help consumers to make a right choice in their purchases. According to this regulation, only certified health functional food can use the Health Functional Food mark and labels. Recently, customers attention for sugar is increasing caused by obesity and diabetes. Therefore, the products need to indicate the sugar on carbohydrate on the nutrition label, and imported products are allowed to use Korean labeling, and revised labeling regulations were prepared to impose the product to indicate the functional level that the KFDA provides. The KFDA is planning to improve the labeling regulation to prevent customer injury and reform unnecessary controls. Pretrial of Labeling and Advertisement for Function Strict pretrial system is in progress, to prevent customer injury from false and exaggerative advertisements, and to promote fair competition and health distribution and sales. Committee of function labeling and the advertisement was constructed with food specialized organizations, customer organization, industry and experts of sitology, dietetics, medical, law and advertisement. It deliberated the 3,022 items (50 times) in 2010, which increased by 24%. It is expected to support industry development by preparing guidelines for labeling and advertising, which considers the properties of each item.
2010
(6) Adverse Effect Monitoring

Collecting the Incidents Assumed as an Adverse Effect The KFDA established Adverse Effect Report System for Heath Functional Food in order to systematize post safety management. Customers, companies and experts can report incidents assumed as an adverse effect to the customer organization (http://www.hfcc.or.kr) or Health Functional Food Institute (http://www.hfood.or.kr) or the KFDA (http://hfoodi.kfda.go.kr). Analysis of Incident Assumed as an Adverse Effect Incident assumed as an adverse effect can be divided as minor and major incident. For a minor incident, an investigation and analysis for information through statistical reasoning of the standard system is being conducted. Also, Korea Integrated System for Signal Manipulation & Evaluation (KISSME) was established to manage and evaluate information efficiently. For a major incident, health information of the reporter and the product and opinion of experts will be secured to reveal the cause. However, from 2006 to April 2011, 463 incidents assumed as adverse effects were reported but there were no causal relationship between the side effect and intake identified.
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Verification of Analysis Result for Side Effect Safety Evaluation Committee for Health Functional Food was formed to verify the result of analysis for adverse effects. It is composed of 20 experts in clinic, pathology, toxic and statistics.
Table 3-4-9 Main Result

Advertisement media Cable TV Content Improving awareness for health function food method of selection for the right product, action for exaggerative advertisement, notice for intake Prevention of injury from exaggerative advertisement Prevention of injury from exaggerative advertisement Better Look, better food advertisement education for proper information Period July 7~ September 6 Note HanbangTV
(7) Customized Education and Advertisement

Consumer Education The KFDA is conducting the consumer education for middle aged to senior consumers to provide proper information of functional substances. This education is a commissioned project. In 2010, the Korean Conference of Consumers Organization (Green Consumer Network in Korea, Korean Federation of Housewives Club, Consumer Korea, National Council of Homemakers, Korea Consumer Affairs Institute, Korean Consumer Education Center, Consumers Union of Korea, National Council of the YMCA of Korea and Korean Womans Association) was held with 4,170 persons (60 times). Manager Education The KFDA is providing education for manufacturers (specialized and venture), importer, seller (general and distribution), and quality manager to secure safety and promote quality improvement. They developed online education programs to improve effectiveness and provide convenience to customers. Advertisement to the Nation The KFDA is providing proper information of health functional food and promoting the prevention of injury caused by exaggerative advertisement, so customers can choose the right product. Figure 3-4-8 Consumer training
Subway video
April 22~May 21
Seoul line 9, 5 areas in Inchoen
Subway frame advertisement Bus frame advertisement Publicity booklet Customer education housewife, middle age, old age
April 19~June 1
Seoul line 5~8 - 600 car 4 megalopolis (Busan, Incheon, Daegu, Gwangju) Distributed at city hall, county office, gu office 60 times 4,170 persons
April 20~May 19 April~November May~August
Figure 3-4-9 V ideo and Paper Advertisement
Providing Information on the Homepage Information of regulation, certification, report, etc is available on the homepage for health functional food (http://hfoodi.kfda.go.kr) providing the proper information for customer, inducing the healthy sales and distribution for company. Especially, information of domestic product that is certified by the KFDA and
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imported product that also reported to the KFDA is available on the health functional food - product information. Customer can check the information of product name, manufacturer (importer), license number (import report number), function, intake method, notice, regulation and standard. Figure 3-4-10 Homepage for Health Functional Food
4) Improvement of Technical Assistance for Competitiveness

A company has to submit the document (regulation, safety, function), according to the Regulation for Certification of Functional Substance, to obtain a certification for functional substance. Due to the lack of awareness of the regulation, there are many troubles experienced. The KFDA held presentation to provide and introduce the regulation and writing method for document. This presentation will be constantly improved to provide the differentiated education and example using detail education.
(1) E stablishment of Technical Assistance and Infrastructure for Health Functional Food
Promoting the Autonomy Registration System for Consulting More companies are requesting the assistance of consulting institute to receive professional support on preparing the material for certification. However, some of the consultants do not have the transparency and professionalism. Therefore, imposing the company to reveal its information (commission, condition, etc.) on its own, reliable information was provided to industry. Now there are 13 consulting companies for
(8) Prospective Plan

From now on, the KFDA will concentrate on improving the nations health and protecting the customer, by securing safety and improving the quality through customized policies for each item and level. First, the KFDA will make an effort for system advancement, in order to secure the safety and function of health functional food. GMP certified companies will be expanded to secure the safe base of manufacturers, import, distribution, and the report management system will be improved. Second, industry support and the fostering method will be prepared to reinforce the competitiveness of health functional food. For that, the foundation of developing the education program and cooperation will be built. And information on the homepage will be improved. Product information application and pre-evaluation systems for advertisement will be developed.
health functional food and their information is available on the homepage of the Korean Health Supplement Association (www.hfood.or.kr). Information of related regulations is being provided regularly. Quality of the companies is also being sustainedly improved by the professional education of the Korean Human Resource Development Institute for Health & Welfare.
(2) P rofessional Education Course - Local Education Academy

Participants of health functional food industry, academia and research started to focus on development of health functional substances, increasing demand of education and counsel for regulation and certification. Various education and informations are provided by the academy to visitors, to satisfy the demand. Educational institution was designated for Seoul, Gyeonggi, Yeongnam, Honam, Hoseo and Gangwon, in order to activate the local industry. The education includes understanding the regulation for certification, matters that require to develop and process, how to set the specification, animal testing to check the functions and toxics, understanding the experiment on a human body, general idea
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of the product and regulation for individual certification. Free job training for local developers of industry, academia and research is operating at the countries in order to improve the awareness of heath functional food.
sharply. At the end of 2010, the cultivation area covered 148 million hectares: 10% increase compared to the previous year (2009, 134 million hectares). Table 3-4-10 Annual Cultivated Area and Cultivation of Gene Recombinant
(3) Expansion of Technical Assistance for Development

The KFDA is providing the technical assistance to promote research and development and vitalize the industry through Technique Council where they analyze the level of technique and provide customized assistance. The Technique Council visited 6 districts (Seoul, Chuncheon, Naju, Jecheon, Busan and Jeju to support. The KFDA also produced the technique check table for regulations, safety and functions. The result of the technique level analysis is like the Table at the bottom. Each level divides into levels: level 4, the certification consulting or level 3, substance standardization or level 2, the safety securement or level 1, general awareness of the regulation or level 0, establishing the direction of research. There was one technique of level 4, 4 techniques of level 3, 9 techniques of level 2, 30 techniques of level 1, and 45 techniques of level 0. Regional conditions of the techniques are shown below.
Area
(10,000 ha)
Agricultural Products
Division 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
170 1,100 2,780 3,990 4,420 5,260 5,870 6,770 8,100 9,000 10,200 11,430 12,500 13,400 14,800
Number of country
12
13
13
16
18
17
21
22
23
25
25
29
Source: International Service for the Acquisition of Agri-biotech Applications (ISAAA)
In 2010, 73 millon ha of beans, 47 million ha of corn, 21 million ha of cotton and 7 million ha of canola take most of the area, 148 million ha. There are 29 countries cultivating GM agricultural products and the top 9 are; U.S., Argentine Republic, Brazil, Canada, India, China, Paraguay and Republic of South Africa, taking up 97.% of the total area when combined. Domestic Condition of GM Agricultural Products Korea has not been commercialized in GM agricultural products. Up to now, the
2. Improvement of Safety Management for Genetically Modified Food and Novel Food
1) Outline
(1) Genetically Modified (GM) Food
GM food is agriculture, marine and livestock product that was cultivated by recombinant DNA Technique, which takes a useful gene from the organism and combines it with the gene of other organism.
Rural Development Administration has developed 150 varieties of 20 products and some of those are in the progress of commercialization including safety evaluation.
(3) Domestic Condition of Supply and Demand of Corn and Bean

Korea has a high rate of dependence on imports. According to the 2008 report from the Korean Rural Economic Institute, the rate of grain self-sufficiency is only 28.4%. Especially, the self-sufficiency rate of corn, subject of GM products labeling system, is lower than 1% and beans, the major source of vegetable protein is 8.6%, which keeps decreasing. Recently, due to the slump in harvest by climate changes, increased demand by economic growth of India and China and increased demand of biofuel, a supply for non-GM product is becoming more difficult.
(2) Current condition of GM Agricultural Products

Foreign Condition of GM Agricultural Products Up to now, 155 varieties for 24 agricultural products were internationally developed. Since GM agricultural products started to be cultivated in 1996, it has been growing
(4) Import Condition of Gene Recombinant Food

Most of GM Agricultural Products importers do not have the gene recombinant
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labeling system, and separation of normal product. Therefore, importers have to choose the one that is separately produced to import non-gene recombinant agricultural products. Similarly, most of the importers are not amicable to GM products. Major international exporters have the management system for classification of non-gene recombinant products, and they impose the cost of it on the price of the product. GM beans takes 80% of the total amount of imported beans and are usually used for cooking oil. Most of non-gene recombinant beans are imported by Korea AgroFisheries Trade Corporation, and are used to make tofu and soya milk. Thus, it is difficult to find the product indicating a GM mark. Since the GM corn began to be imported in May, 2008 due to the international order imbalance, social concern became higher. The imports shrank a little by the customers refusal of GM corn since September, 2008. In 2010, 48% of GM corn were imported.
(2) Related Regulation

Following international trend of obligating the safety evaluation, Korea also revised the Food Sanitation Act to establish the safety evaluation article for GM food in August, 2002. It revised Adrticle 18 to establish the Evaluation Committee for Safety of Gene Recombinant Food. Table 3-4-11 Regulation for Safety Evaluation
Law Food Sanitation Act Enforcement ordinance for Food Sanitation Act Enforcement regulations for Food Sanitation Act Article Article 18 Content Safety evaluation for gene recombinant food Regulation for subject of safety evaluation. Establishment of the evaluation committee for safety information Commission - 4 million won Date of legislation and revision Revision : August 26, 2002. February 6, 2009 Revision: April 22, 2003 August 7, 2009 Revision: December 29, 2006 Legislation: August 20, 1999 Revision: September 1, 2003 May 4, 2006 August 30, 2007 August 24, 2009 December 22, 2009
Article 9, 10
Annex
(5) Management of Gene Recombinant Food

The management of GM food can be divided into safety management and labeling management. Safety management evaluates the products before it is distributed. Labeling management imposes the GM food to indicate the result of evaluation.
Notification
Notification 2009The designation including the 196. safety assessment object, safety Regulation assessment inspection procedure, for the safety submission of documents range, and evaluation of gene etc. recombinant food
2) S afety Evaluation and Pre Management for Gene Recombinant Food

(1) Legislation and Revision of Regulation
To secure the safety of GM food, Regulation for Safety Evaluation of GM Food and Additives was legislated in 1999 (KFDA notification 1999-46, August 20, 1999). In August, 2002, base articles were established for safety evaluation, by revising the Food Sanitation Act, and on this basis, a safety evaluation was obligated in February, 2004. Also, evaluation guidelines were completely revised in 2003, range of evaluations for GM organisms (GMO) was expanded in 2006, and evaluation subject, regulation, condition for certification was improved in 2007.
(3) R ange and Evaluation Procedure for Required Information of GM Food

The safety evaluation handles the toxic and allergic differences between before and after the gene recombination through analyzing the techniques and substances. According to internationally concerted regulations, CODEX, required information for this includes the properties and toxicity of the host and gene donator, history, combination method and properties of donator after it is combined. After confirming the new changes of the host organism and combined organism, its safety needs to be evaluated and then submitted. Procedure of safety evaluation is like Figure (3-4-11)
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Figure 3-4-11 P rocedure of Safety Evaluation for Gene Recombinant Food
(2) Regulation
Regulation for gene recombinant food labeling system is like the following:
Applicant
Application form, safety evaluation material and summary
Organization via
Application
Processing machinery KFDA

Receipt Evaluation Committee evaluation and writing the report
Table 3-4-12 Regulation for GM Food Labeling System

Regulation Revision of Food Sanitation Act Article 10 (January 12, 2000) Revision of Food Sanitation Act Article 12 (July 31, 2001) Content Establishment of base regulation for obligating the GM food labeling Preparing the regulation for import report of GM food
Evaluation period : 270 days
Release on the official gazette and homepage
Releasing report and collecting opinion Final review and report
Notification
Result
Approval
Legislation of subject, time and regulation (August 30, 2000). Revision of labeling regulation according to the establishment of Regulation for Health Establishment of Regulation of GM Food Labeling Functional Food (January 31, 2004). Revision of labeling regulation according to (August 30, 2000) expansion of subject item (November 14, 2007) Establishment of deadline for reexamination according to Regulation for Instruction and Rule Management (August 24, 2009)
(3) Subject and Method for Labeling (4) Current Condition of the Safety Evaluation for GM Food
There is 71 approved GM agricultural foods (bean, corn, cotton, canola, sugar beet, potato, alfalfa, etc.), 15 food additives (enzyme) and 1 microorganism, in Korea. There are 28 approved products that contain the gene recombinant DNA and foreign protein. After production and processing, they are subject to the gene recombinant food labeling system. It does not include the products that is refined and produced without the gene recombinant DNA (syrup, soy sauce, cooking oil). Subject products have to label the GM Food for GM ~ Containing Food in a font bigger than 10 points on the front side. And if it is impossible to confirm gene recombinant substance, the product can label Potentially Containing GM Substance.
(5) C urrent Condition of Management for Unapproved Products

According to Article 18 of the Food Sanitation Act, it is an obligation to evaluate the safety of GM products and GMO and it is illegal to import, distribute and sell the unapproved products. Pest resistant rice of China, herbicide resistant rice and pest, herbicide resistant corn of the U.S, herbicide resistant flaxseed of Canada and virus resistant papaya of Japan are examples that have to go through import examinations.
3) Gene Recombinant Food Labeling System

(1) Purpose
It obligates the gene recombinant foods to indicate the GM mark to secure proper information, right to know and choice of customer.
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1. Preventive and Scientific Management Infrastructure of Food Hazards 2. Securing Health by Food and Nutrition Management 3. Preparing the Organic and Systematic Safety Management from Raw Material to Consumption 4. Establishment and Operation of Food Safety Information Center 5. Reorganizing Standards and Specification for Food, Food Additives, Equipment, Container and Packaging
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Table 3-5-1 Legislation and Revision Regulation and Standard of Food

Legislation and revision of regulation and standard Date January 7, 2010 Revision of regulation for the amount of germ in the snacks. Establishment of 6 categories of food Establishment of residual pesticides(Cyenopyrafen, Prohexadion-ca, Tetramethrin) Establishment of regulation for cadmium and lead in agricultural products (garlic, carrot, chives) and livestock products (beef, pork, poultry) Establishment and revision of regulation for fumonisin in corn food and Ochratoxin A in Meju and pepper powder Addition of regulation and test method for similar substance of erectile dysfunction cure Establishment of liquid chromatograph test method for folic acid, choline and biotin Establishment and revision of regulation for residual pesticide. Establishment and revision of fungal toxin regulation and test method Addition of regulation and test method for new erectile dysfunction cure Definition of noodle and improvement of food category Establishment and revision of regulation for colon bacillus and Vibrio parahaemolyticus in an instant and convenience food Establishment of regulation for frozen fish organs and expansion of definition of frozen fish head Revision of test method norovirus in water Revision of regulation for Bacillus cereus in Kimchi and salted fish Establishment of regulation for heavy metal in agricultural products and animal byproducts Establishment of regulation of total aflatoxin in flour and dry fruits Establishment of regulation for the fungal toxin in grains Revision of principle of unapproved animal drugs Addition of regulation and test method for new erectile dysfunction cure Establishment of regulation for benzopyrene in smoked fish Establishment of regulation for microorganism in the vending machine tea, coffee, beverage Establishment of regulation for heavy metal in the flour and wine Establishment and revision of regulation and test method for animal drug Revision of test method for paralytic shellfish poisoning and heavy metal Establishment and revision of regulation for residual pesticide in the agricultural products Establishment of regulation for new pesticide (Isotianil) Revision of application principle for method Addition of reclassification and substance item for vegetable substances Modification of words for dividing the food substance Disambiguation of acid value regulation for general processed food Revision of methanol and sulphur dioxide regulation for spirituous liquor Revision of regulation for fruits and vegetables processed product Revision of regulation for marine products Revision of test method for fatty acid and trans fat Revision of test method for bacillus cereus Revision of regulation for residual pesticide Establishment of regulation for residual pesticide in the agricultural products and ginseng Establishment of residual regulation for new pesticide
05
Reorganizing Standards and Specication for Food, Food Additives, Equipment, Container and Packaging
April 30, 2010
1. Management Food Standards and Specification

1) Management Food Standards and Specification
Based on the discovery of new substances and advances in technology to detect hazardous materials, there is a demand for strengthen domestic standards and specifications for hazardous materials. Some substances without domestic standards are being discovered in imported food, causing the authority to return such products. Hence, the KFDA prepared appropriate level of standards and specifications by newly establishing or amending relevant standards for harmful substances.
June 16, 2010
June 30, 2010
2) M ajor Contents in Establishment and Revision for Standards and Specification

The KFDA reviewed the result of monitoring and toxin examination and collected the opinion of industry, customer organization and experts, to establish the scientific and rational regulation. After collecting national opinions and reporting to WTO, the food sanitation committee deliberated over the results. Recently, the regulation for toxic substances was reinforced and eased the quality regulation, due to the condition of rising pollutants. In 2010, regulations for heavy metals, mold, pesticides, animal drugs, microorganisms and new toxic substances were established as the level of CODEX, EU, U.S., and Japan and the foundation for development of proper food were prepared.
July 23, 2010
October 29, 2010
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Legislation and revision of regulation and standard Revision of regulation for residual pesticide in agricultural products (9 kinds of pesticide including Buprofezin for chili pepper Establishment of regulation for residual pesticide in agricultural products (41 kinds including Deltamethrin) Establishment of regulation for salmonella in the cocoa products, chocolate, peanut and nut products Establishment of regulation and test method for Enterohemorrhagic E. coli in fruits and vegetables juices Materialization of sanitation regulation for process and produce of salted fish Establishment of regulation for carbon monoxide in Japanese amberjack Revision of regulation for cooking and management of restaurant food Addition of prohibited substances for food items Establishment and revision of regulation for residual pesticide
Date December 1, 2010
2. Systematical Management of Food Substance

1) Background
Recently, development of new product became more active. Therefore, new management system was needed to be established to secure the variety of food
December 31, 2010
substances and expand the choice of customers. Meanwhile, it became essential to provide general information of food substances to persons in charge of food management and safety information to customers.
2) Result 3) Improvement of Capability for Food Safety Management

To improve the awareness for regulation of toxic substances and effectiveness of food safety management, Food Regulation Presentation was held at 147 officials in four occasions. Also, On-site Presentation was held for 1,054 persons for nine times. Quality Manufacturer Visiting Project was operated to induce the voluntary sanitation improvement and quality production for instant food restaurant. Also, Food Standards Codex Improvement Council was established to improve the food standards codex.
(1) Reorganization and Expansion of Food Substance Management System

The KFDA amended (KFDA notification 2010-31, May 12, 2010) the Temporary Regulation, Standard and Approval Regulation in order to establish the advisory committee and approve the food substances. Also, revised classification system added 13 items, including new mushroom, to the list of Serviceable Substances for Food (KFDA notification 2010-78, October 29, 2010) and added the 34 items including poisonous mushroom to the list of Inapplicable Substances for Food (KFDA 2010-102, December 31, 2010)
4) Expected Effectiveness and Prospect Plan

Through toxic regulation improvement, trust of the customer can increase, establishment of rational regulation can activate the market, and with these, food industry is expected to advance. Microorganism regulation for the infant and baby food will be revised according to its risk level. Cadmium and lead regulation will be expanded to whole agricultural product, and fungal toxin, benzopyrene, heavy metal regulation will be reinforced to improve the safety management for infant and baby food. Regulation for olychlorobiphenyl and paralytic shellfish poisoning will be established. Also, import tolerance system will be intensified to improve the safety management for the residue of imported product. Existing regulations will be scientifically reappraised.
(2) Expansion of Advertisement and Education for Proper Selection

In order to improve the advertisement for proper selection of substance, the KFDA printed and published the coverages like Proper intake of spring greens (March 11, 2010), Edible flowers and caution (May 27, 2010) and Distinguishing the poisonous plant and fist aid (June 1, 2010). The administration also held the conferences like New management system for food substances (June 1, 2010) and Requirement for food substances (marine product, September 9~10, 2010) and published 70,000 leaflets for proper use of food substances to food organization, customer organization, city and province.
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Figure 3-5-1 Advertisement Leaflet Food Substance Guide
3. Management of Food Additives Regulation

In order to establish the advanced regulation and safety management, food additives classification system and safety regulation were improving in 2010. Similar items were combined (12 5) to improve the food additives classification system. For the induction of the development of various products, Amidated Pectin and - Acetolactate decarboxylase were designated as food additives. Lead, colon bacillus regulation for 167 items including Iron citrate was established and improved to secure the quality of food additives and reinforced the regulation to CODEX level. Regulation for fortifying nutrient of infant and baby food was rearranged. Regulation for synthetic preservative such as Sorbic acid was established. And Food Additives Guide by Food Types, Handbook for Revision and Legislation of Food Additives Regulation, Guideline for Establishment of Food Additives Regulation and Revision of Utilization Standard and What is Food Additive? were published to provide proper information. Table 3-5-2 Current Condition of Legislation and Revision of Food Additives Regulation
Major legislation and revision Revision of substance regulation for 258 items including benzoyl peroxide Designation of natural food additives -Acetolactate decarboxylase. Revision of utilization regulation of 3 items including Ferrous Gluconate Revision of utilization regulation to prohibit Food Red No.102 to use in Childrens favorite food Revision of Utilization Standard classification system Combination of component specifications for some items (12 > 5) Date May 19, 2010 July 12, 2010 August 18, 2010 September 29, 2010 November 12, 2010
3) Expected Effectiveness
By revising and expanding the food substance management system, industry was expected to be invigorated, and by expanding the advertisement and education, customers convenience is expected to be improved. Also, it can prevent the food accident, and improve the customers choice.
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4. Management of Regulation and Specification for Utensils, Container and Packaging

For scientific and effective pre-safety management, plastic containers residual solids were expended from one (4% acetic acid) to 4 types (water, 4% acetic acid, 20% ethanol, n-heptane). Migrant specification for Sulphur dioxide, Ortho-phenylphenol, Thiabendazole, Biphenyl, Imazalil in Wood Product was established to secure the safety of customer. Migrant specification for Nitrosamines and Nitrosamine generable substance that can be used for pacifier was established. The leaflet on Guide for Safe Use of Cooking utensils was printed in illustration style, and information for crystal and glass was provided on the homepage as Q&A style. Table 3-5-3 Current Condition of Legislation and Revision of Regulation for Utensils, Container and Packaging
Legislation and Revision of Regulation Establishment of migrant specification for 11 kinds of synthetic resins such as polyethylene Improvement of heavy metal regulation for 37 kinds of synthetic resins such as polyvinyl chloride resin. Elimination of provisory clause only for wooden chopsticks for migrant specification of Sulphur dioxide, Ortho-phenylphenol, Thiabendazole, Biphenyl, Imazalil Establishment of 4-methyl,1-pentene migrant specification for 6 kind of synthetic resins such as polymethylpentene Establishment of specification for 1,3-Butadiene, Nitrosamines and Nitrosamine generable substance (only for pacifier) E stablishment of migrant specification for laurolactam of 3 kinds of synthetic resins E stablishment of migrant specification for 4,4-methylenedianiline of Epoxy resins coated metal container, utensils and packagings Date
5. Management of Standards and Specification for Disinfectant of Equipments

11 types of substances, including naphthalenesulfonic acid sodium, were eliminated from the list due to lack of safety data. Also, -alkyl(C6-)--hydroxypoly (oxypropylene) was established, and names of 3 substances that are similar such as -alkyl (C10C14)--hydroxypoly(oxyethylene)poly(oxypropylene) were combined and changed. To standardize officially the temporary standardized items, regulations for citric acid were established. Table 3-5-4 Current Condition of Legislation and Revision for Regulation of Disinfectant for Utensils
Legislation and Revision for Regulation Date
Notification (March 3, 2010)
Elimination of 11 substances including naphthalenesulfonic acid sodium which can be used for disinfectant Establishment of -alkyl(C6-)--hydroxypoly (oxypropylene) for usable substance Combination of 3 substances that are similar such as -alkyl (C10-C14)- -hydroxypoly(oxyethylene)poly(oxypropylene) to 1 item
Notification (June 17, 2010)
Notification (September 18, 2010)
Establishment of regulation for official standardization of temporary standardized citric acid
Notification (July 12, 2010)
Announcement (December 28, 2010)
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Chapter 04
Pharmaceutical Products
01 Current Status and Progress in Pharmaceutical Product Safety Management 02 Promoting Appropriate and Safe Use of Pharmaceuticals 03 Assistance in Commercialization of Pharmaceuticals 04 Establishment of Foundation for Supply of Safe and Effective Pharmaceuticals 05 International Cooperation in Pharmaceutical Sector
1. Current Status and Progress in Pharmaceutical Product Safety Management 2. Promoting Appropriate and Safe Use of Pharmaceuticals 3. Assistance in Commercialization of Pharmaceuticals 4. Establishment of Foundation for Supply of Safe and Effective Pharmaceuticals 5. International Cooperation in Pharmaceutical Sector
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Compared to the average annual growth rate (9.7%) during 2003 ~ 2008, the growth rate of domestic pharmaceuticals slowed down for last 2 years.
01
Current Status and Progress in Pharmaceutical Product Safety Management
Figure 4-1-1 Annual Production of Domestic Pharmaceuticals

170,000 150,000 130,000 110,000
96.374 105.985 10.3 10.3 138.938 157.098
12.0 10.0
10.0 8.0 114.728
9.8 125.982
147.879
6.4
6.2
8.0 6.0 4.0
1. Changes in Pharmaceutical Environment

As assurance of safety and efficacy of pharmaceuticals are directly related to the lives of humans, many strict and mandatory regulations are enforced on the manufacture of pharmaceuticals. Pharmaceutical manufacturers and importers also play an important sociological role and contribute to the society accordingly. The development of medicinal products has contributed for the realization of the public health such as treatment, reduction, handling and prevention of disease, and the advancement of high technologies has been accompanied with the development of medicinal products. Also, it has had a ripple effect on various kinds of academic areas such as biology, engineering, information science and statistics, and it has been in the limelight as a knowledge-intensive and high value-added industrial future growth engine. The progress of medical technology contributes not only for the reduction of medical expenses along with the quality improvement of medical treatment but also to the decrease treatment period and improve the quality of life. The KFDA has been leading the establishment of strict control system of safety, efficacy and quality and the establishment of the internationally harmonized regulation system.
90,000 70,000 50,000 2004 2005 2006 2007 2008 2009 2010
Domestic production (100million) Growth rate compared to the previous year
2.0 0.0
The portion of domestic pharmaceuticals in Korean gross domestic product (GDP) and GDP of manufacturing industry declined slightly compared to 2009 (1.39 1.34% for GDP, 5.56 5.47% for the manufacturing industry GDP). In 2010, the domestic pharmaceutical market share (production + import - export) of the world marketplace was 19,143.7 billion won (16.56 billion dollars), which increased 5.1% (16.0% by dollars) compared to the previous year (18,220.4 billion won, 14.28 billion dollars). The domestic pharmaceutical market accounted for 1.9% of the world market (856 billion dollars) and increased by 0.2% compared to the previous year (1.7%). The market shares by region were 42.3% in North America (334.8 billion dollars), 29.2% in Europe (230.7 billion dollars), 12.4% in Asia/Africa/Australia (98.1 billion dollar), 10.8% in Japan (85.7 billion dollars) and 5.3% in South America (42 billion dollars). The world market share of domestic pharmaceuticals is still low compared to North America, Europe, China and Japan. The top domestic company in the manufacturing industry of the drug is Dong-A Pharmaceutical, followed by Daewoong Pharmaceutical, Hanmi Pharmaceutical, Green Cross, and Handok Pharmaceuticals. The production figures of Green Cross have been largely increased by the influenza vaccine for the last 2 years (455.8 billion won 562.7 billion won, 23.5% increase). The 6 largest companies occupied 25% of production, and the 20 largest companies occupied 53.2%. It was shown that large
1) Pharmaceutical Market Trend

In 2010, the domestic production of pharmaceuticals was 15,709.8 billion won, increased by 6.23% compared to the previous year (14,788.4 billion won) due to the deterred production of raw material, which previously displayed annual growth of 10%.
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companies have continued to lead the market similar to the previous year (53%). The production of prescription drugs was over 11 trillion won (11,509.8 billion won, increased 8.1% compared to 10,649.4 billion won of the previous year), and the production of medicines for chronic or adult diseases, such as antiarteriosclerotic agents and antihypertensive agents, has been continuously increased. Vaccine production also increased by a double-digit percentage. The share of prescription drugs in the market has been increased by 1.2%. (72.4% in 2005 80.8% in 2009 82% in 2010) Most of newly developed drugs and incrementally modified drugs (IMD) of the nation were prescription drugs and their productions have been dramatically increased in recent years. Hence, their market share is expected to increase (new drugs: 13,150 million won (7 products) in 2004 51,250 million won (9 products) in 2010, increased by 289.7%) (IMD: 24,880 million won (2 products) in 2009 65,520 million won (6 products) in 2010, increased by 163.3%). Figure 4-1-2 Trade Statistics over the Past 7 Years
60.0 50.0 40.0 30.0 20.0 10.0 0.0 -10.0 -20.0 -30.0 -40.0 2003 2004 2005 2006 2007 2008 2009 2010
-14.7 -15.9 -19.8 -27.2 -28.7 -29.8 -26.9 -29.7 Trade Surplus/ Deficit 21.7 7.0 23.0 7.1 36.3 27.8 8.0 9.1 10.3 11.5 14.0 17.2 Export 39.0 41.3 40.9 46.9 Import
In order to overcome the productivity problem of new drug development, the new drug development, which applies high biotechnology, has been performed actively. The examples include targeted treatment solutions and gene-based therapies based on personal gene analysis, which are replacing traditional drugs and development of low molecular weight compound. The use of genetic information for targeted patient group narrows treatment targets and enables subsequent expansion of target groups. The high-tech clinical test techniques, such as micro dosing, increase the success rate of new drug development. Also, the research on biological activity and design of medicine through simulations such as diagnosis and treatment fusion through bioimaging, high-throughput screening (HTS), in silico (virtual test) and virtual screenings are also being used. The domestic new drug R&D has a considerable competitiveness. The phase 1, 2 clinical trials, which require advanced technique, is increasing every year, and 202 multinational clinical trials, 198 local clinical trials have been performed after the introduction of IND system in early 21st century.
3) Safety Management
The safety management of pharmaceuticals is being highlighted with reinforced role of regulative authorities and their globalization based on low birthrate and aging society, the increase of chronic disease, the generalization of geriatric disease, and global warming and climate changes. Due to the paradigm shift in medical services to focus on the patient focused medical treatment system and the increasing interest and requirement of detailed information on pharmaceuticals, the provision of appropriate drug information provision is essential to promote reasonable choice and use of drugs. The authority which determines policy should consider the reinforcement of surveillance, such as financial evaluations, according to the increase in medicine/medical expenses. Because of the progress of globalization by FTA and other means, the pharmaceutical industry has escaped domestic market and entered unlimited competition in the global market. Advanced countries established common pharmaceutical regulations for approval, evaluation and quality assurance through the International Conference of Harmonization (ICH) and distributed them to the global community.
2) Research & Development Trends

The R&D investments of large global pharmaceutical companies have been continuously increased to 123 billion, but the successful development of new drug has been stagnant. This Innovation Gap is due to long development duration (10~17 years), high expenditure and risk (under 10% of success rate, difficulties of safety prediction, and uncertainty of approval), and low investment-benefit rate.
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2. Past Projects and Assessments

The KFDA has spontaneously confronted with environmental changes in the field of medicine. They established preventive safety management and approval & evaluation system, the basis for drug quality control at the level equivalent to advanced countries, and the basis of new drugs and generic medicine development.
for reinforced efficiency and professionalism of approval review works through the rationalization of drug approval review fee.
2) Establishment of Pharmaceutical Quality Control Basis at the Level of Advanced Countries

The KFDA implemented various management systems, such as Good Research Practice (GRP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Supply Practice (GSP) from 1990s for each phase of the management system. However, the data fabrication of bioequivalence test data in 2006 caused the public to distrust its management system. The KFDA expanded the scope of products that need to be proved on safety and efficacy through bioequivalence test, to establish overall quality control system from raw materials to complete product, and actively reinforced quality control through expansion of the target area on Drug Master File (DMF) of raw material. From new drugs in 2008 to raw materials in 2010, the KFDA changed existing largescale dosage-form-oriented-evaluation to product-oriented-evaluation in a phased manner, and only provided approval to appropriate cases. Also, it implemented mandatory validations.
1) E stablishment of Preventive Safety Management and Approval & Evaluation System

The concept of monitoring adverse effects of pharmaceuticals was introduced in 1988 but was not effective at all. The KFDA revised Regulation on Managing Safety Information of Pharmaceutical Products and specified the time limit for safety information report, the assessment procedures and standards and the distribution method. The administration designated regional drug monitoring centres (3 in the metropolitan area, and 3 in rural regions) from 2006, established information gathering system in hospitals and clinics on adverse effects, and now operates 15 regional drug monitoring centres. The number of adverse effect reports has been increased rapidly through promotion and trainings and the provision of incentives. Also, the KFDA has provided Drug Utilization Review (DUR) on prescription information, such as duplicate prescription, long-term prescription, contra-indicated drugs, and age-limited drugs to prevent misuse and abuse of pharmaceuticals. In order to prevent medication error in locations for pharmaceutical prescription and preparation, the KFDA provided proper drug use information to medical professionals, such as doctors and pharmacists. The administration also investigated drug approval factors and provided standards on prohibited drugs with possible risks to public health by age, dosages and health insurance benefits (with Health Insurance Review and Assessment Service). The KFDA internationalized submission data for new drug approvals, expanded targets, such as anticancer drugs, for rapid evaluations, and established approval and evaluation guidelines, to respond actively to changes in the global trend and support the public by improving policies. The administration also introduced Good Review Practice (GRP) to enhance reliability of the review works. Lastly, it established a basis
3) Establishment of the Basis to Promote Development of New and Generic Drugs

The scale of domestic non-clinical and clinical trials has grown rapidly through the introduction of GCP in 1995, a total revision of drug safety management standard in 1998, mutual approval of OECD Good Laboratory Practice (GLP) in 2000, approval system on clinical trial in 2002, and with the effort of R&D initiated by government and enterprises. Korea has become a clinical trial technique powered country with assured reliability in the Asian region since the late 20th century. Since its establishment in 1998, the KFDA established relevant legislation, systems and infrastructures of licensing, approval and safety management for the overall development and production process. It introduced and established scientific control systems, such as Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good
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Manufacturing Practice (GMP), Good Supply Practice (GSP), for each of management phase and improved the drug quality control basis. By actively responding towards environmental changes in drug safety control, the KFDA now possesses pharmaceutical safety management capability of the global standard, including safety management of non clinical trials, clinical trials, approval & evaluation and adverse effects control. With this environment available, the KFDA should focus on enhancing its control system and contributing to international policy developments by sharing its regulation with the global community. The KFDA should also take actions in preventing or responding towards adverse effects and respond to safety incidents of wrong medicine prescriptions and preparations.
2) Enhancement of Effectiveness on Gathering and Providing Information for Medical Specialists

The KFDA expanded regional drug monitoring centers, and enforced mandatory reporting of pharmaceutical adverse events by medical facilities. (Monitoring centers: 15 in 2010 20 in 2011 25 in 2012 30 in 2013) The KFDA expanded Drug Utilization Review (DUR) by adding more pharmaceutical ingredients to watch out for duplicate or long-term prescriptions, and expanded the list of pharmaceuticals that are contra-indicated, age-limited and disease-limited (979 ingredients in 2009 over 2,000 ingredients in 2010)
3. Directions in Pharmaceutical Safety Management

The pharmaceutical safety management of 2009 revolved around consumer safety by providing safety information, mandatory reporting of medical facilities on adverse effects of pharmaceuticals, strengthened cooperation with the government and medical sectors, and establishment of professional organizations to manage adverse effects, with the consideration of domestic situations and environments.
3) Establishment of Drug Safety Information Management Institute

The KFDA established Drug Safety Information Management Institute, a nonprofit organization, to collect, analyze, assess and distribute of drug safety information. The institute will run a website to report adverse events (similar to the Medwatch system of U.S.), and produce, process and distribute DUR information and manage adverse events.
4) Establishment of Effective Recall System 1) Expansion of Customized Medical Information for Consumers
The KFDA developed and distributed the Manual on Safety Use of Pharmaceuticals at Home per drugs types, age group and disease types. It ran a project to establish Online Library of Pharmaceuticals to provide overall information, such as drug identification, warnings, and directions for use of pharmaceuticals. They also enhanced directions for use of drugs so that they are easily understood by consumers and medical specialists. The KFDA developed Web Fax, Recall Information Distribution System using SMS and Real-time Recall System for effective pharmaceutical product recall, through cooperation with Information Center of Health Insurance Review and Assessment Service. Furthermore, they tried to supplement the system by setting up recall plans, reducing recall periods and introducing recall assessment system. The KFDA conducted regulatory reforms to improve pharmaceutical policy, promoted the development of high quality pharmaceuticals, and established the basis for advanced pharmaceutical industries to enhance their competitiveness. The administration also focused on the harmonization with international regulations, such as GMP management system, and reinforced international cooperation.
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1. Current Status and Progress in Pharmaceutical Product Safety Management 2. Promoting Appropriate and Safe Use of Pharmaceuticals 3. Assistance in Commercializ ation of Pharmaceuticals 4. Establishment of Foundation for Supply of Safe and Effective Pharmaceuticals 5. International Cooperation in Pharmaceutical Sector
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Table 4-2-1 Adverse Effects Reporting by Year

year 2000 185 2001 363 2002 148 2003 393 2004 907 2005 1,841 2006 2,467 2007 3,750 2008 7,210 2009
(Unit: case)
2010
02
cases
26,827 53,854
Promoting Appropriate and Safe Use of Pharmaceuticals
The KFDA is continuously developing statistical analysis methods to evaluate the cause and effect of domestic adverse effect reports. It also developed an efficient system to collect safety information from foreign sources by establishing contact systems with pharmaceutical companies and by searching and gathering information on-line. It allowed doctors and pharmacists to search for drug safety information faster and easier manner, and established a section on its website (http://www.kfda.go.kr) to share 'Changes in Pharmaceutical Approvals' for doctors and pharmacists to trace any changes in approval requirements. The KFDA directed 264 safety measures in 2008, such as limiting the approval for diazinone, and 283 in 2009, such as modifying approval content of gabapentin. In 2010, the KFDA directed 144 safety measures, such as prohibiting the use of sibutramine or modifying approval content of another 115 drugs.
1. Active Reporting of Adverse Effects and Scientific Assessment of Pharmaceutical Safety Information
The KFDA revised the Regulation to Manage Safety Information of Pharmaceutical Products in 2004 and 2005 to specify reporting period, assessment procedures and standards, and distribution method. In 2007, it became mandatory for pharmaceutical companies to hire an employee in charge of post-market management through adverse effects monitoring or any other methods. In 2008, the KFDA requested pharmaceutical manufacturers and importers to report safety information on an annual basis and made reasonable improvements in risk events that required an immediate reporting. Lastly, it enforced relevant businesses to prepare Drug Surveillance Standard Manual. The KFDA also operates regional drug monitoring centres for active drug monitoring. The centres collect adverse effects information of the region, reward participating institutions or reports and train doctors and pharmacists in an adverse effect monitoring. There were 6 regional drug monitoring centres in 2006, and now 15 centres are active (2010). It is to expand to 20 centres by 2011 to reinforce information collection capacity. The number of domestic reports on adverse effects of drugs continuously increased, showing 1,841 cases in 2005, 2,467 cases in 2006, 3,750 cases in 2007, 7,210 cases in 2008, 26,827 cases in 2009, and 53,854 cases in 2010.
2. Provision of Information on Appropriate Usage of Pharmaceutical Products

The information in appropriate usage of pharmaceutical is systemically developed and provided to prevent the products misuse and protect the public health. It also enables medical specialists to use information during prescribing and preparing medicines. The methods to secure the safety of patients through safe and optimal use of drug and save unnecessary social expenses have been developed around the world. The advanced countries such as U.S. or U.K. are running Drug Utilization Review (DUR), the cycling system that provides information on the safe and appropriate use of drug, monitors and reviews usage of drug, and provides new information based on the assessment. In Korea, the Health Insurance Review & Assessment Service announced results of
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improper use of drugs through assessment on the appropriate use of drug since 2001. However, there were limitations because there is no system available to distribute the information to the public or assess the information. The Ministry of Health and Welfare began to provide information on appropriate use of drugs that were prohibited from mixing and had age limits in 2004 and that became the start of information provision in the appropriate use of drugs. In September 2005, the responsibility to develop and distribute such information was given to the KFDA, which was specializing in the assessment of safety and efficacy of drugs. The Ministry of Health and Welfare and the Health Insurance Review & Assessment Service took the role to manage and inspect that pharmaceuticals were being used in appropriate manners. After the transfer of responsibility, the KFDA has been adding the list of drugs that possess higher risks, are prohibited from joint use, have age limits and are prohibited for use by pregnant women, to supplement current information on the appropriate use of drugs. As of 2010, the KFDA is providing and controlling 473 ingredient combinations of medicines prohibited from joint use, 108 medicines prohibited from use in a certain age, and 314 medicines prohibited from the use by pregnant women. In 2010, the KFDA developed and distributed a 'Booklet of information on appropriate use of drugs for pregnant women' for pregnant women and non-specialists the field of gynecology. The KFDA is also preparing to publish similar booklets for children, patients with nephritis and epileptics in 2011. Likewise, it is determined to lead safe and proper prescription and preparation of medicine through the development and distribution of information on treatment dosage, time period, and duplicated drugs to improve public health.
The KFDA established and operated private-public consultation composed of the Korea Consumer Agency, Consumer's Korea, the Korean Pharmaceutical Association, the Korean Society of Health-System Pharmacists and 10 other related specialists recommended by pharmaceutical communities. The group prepared methods to support the distribution of non tar coloring cold medicine for children in Jul 2009, to ease the anxiety of consumers on tar colorings. As detailed support plans, 'dye-free' label was allowed to be displayed on the external container and package to make it distinguishable, and efficiently processed approvals for tar coloring free syrups by designating them as 'priority evaluation target' for 1 year from July 1, 2009. The KFDA established the distribution plan of dye-free products to expand the right of choice of consumers although it recognizes that coloring may prevent from their misuses. Moreover, targets drugs that require safety container/package to prevent safety accidents caused by improper drug use in children are being expanded. The safety container and package of drugs were introduced to prevent drug safety accident, such as overdosing by easy unlocking, and careless handling and storage of drugs at home. In the previous regulation, only 5 substances, including product containing iron over 30 mg, had to use child-proof container/package. Since the revision of the Pharmaceutical Affairs Act of June 19, 2009, the drugs containing loperamide (used in diarrhea medicine), naproxen and ketoprofen (anti-inflammatory analgesic drug), should use this container/package. There drug labels are often wordy and unclear, causing consumers misunderstand important information while the demands on medical supply safety information of consumers are growing fast. The clarity of the markings on drugs was also low for some consumers. The KFDA established a working group with the specialists
3. Establish Children-Friendly Environment for Drug Consumption

The KFDA encouraged the supply of syrups for children without colorings to establish a safe environment for children's drug consumption, and expanded drug types which need safer containers or packages to prevent safety hazards caused by improper use in children. Finally a consumer friendly labeling of drug information was implemented in children's medicine.
recommended by medical communities, pharmaceutical communities and consumer communities, such as the Korean Medical Association, the Korean Pharmaceutical Association, the Korea Pharmaceutical Manufacturers Association, the Korean Research-based Pharmaceutical Industry Association, the Korea Consumer Agency and Consumers Korea. The working group is trying to enforce the manufacturers to change labels on drugs for easier recognition, both visually and intellectually. The KFDA tried to satisfy consumer's right to information by researching basic terms related to important facts on drugs and labeling by reviewing 736 simple terms in 2009
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and 66 simple terms in 2010. The administration combined the Guideline for Labeling of Pharmaceutical Products and Rules on Tablet Imprint Identifier to establish a Regulation on Pharmaceutical Product Labeling, improving the publics understanding on pharmaceutical labels. According to the regulation, medicines that require the use of the general term must display the term them beside the professional term. (i.e. "Expectoration (phlegm)" or "bite (injury through biting)"). The font size should be over 6~7 point according to the Korea Industrial Standard, and only key information should be written on the outer package. On the container or package, product name, expiration date, the name, standard and quantity of active ingredients, and identification for "prescription drug", "over-the-counter drug" and "drugs with potential abuse and misuse" should be displayed with font size 7+, while the other information should be written in font size over 6 point. The attached leaflet in the package should use the font size 7+ if it is over-the-counter drugs and 6+ for prescription drugs while spacing between the lines should be 0.5+. The important warnings for drug found in its approval information should be written in letter box, and others should use appropriate fonts such as bold letters, shades, colors and letter boxes for easy distinction. Since secondary packages for drug information leaflet is often lost, the address of online KFDA medicine information forum or company website should be written on the container and package to allow consumers to search for further information.
dispensing of drugs, the development of information technology including the internet and advance in transportation technology such as parcel service or airmail, have not only diversified the distribution route of illegal or defective drugs but also torn down the border lines between countries existing to prevent the illegal distribution or spread of happy or illicit or counterfeit drugs with potential abuse and misuse. The KFDA and local government performed frequent pharmacovigilance on illegal or defective drugs based on reporting and information to find illegal traders. The administration also tried to block or eliminate manufacturing sites used to provide illegal sales of drugs. A MoU was also signed with the Korean Internet Corporation Association for cyber monitoring of illicit drug distribution. Table 4-2-2 Blocking and Elimination of Request for Illegal Sales of Drugs
(Unit : case)
year Number of requests made through the internet
2007 394
2008 168
2009 449
2010 822
The KFDA is working with Criminal Investigations Office and the National Police Agency to build an efficient monitoring system on the illegal distribution of drugs. This includes the surveillance on the distribution of illegal/defective drugs and the blockage of the domestic inflow of illegal/defective drugs, by utilizing imports information network of the Korean Customs Service.
4. Activation of Network to Prohibit Distributions of Illicit and Defective Drugs

Illicit and defective drugs are defined as a drug without approval from the Pharmaceutical Affairs Act (unauthorized), a drug containing different or insufficient active ingredients compared to its approval data (defective), and a drug that imitates or is a fake version of the approved product. (Refer to Article 3 of the Special Measures to Restrain Public Health Crime). In the past, distribution of illicit/defective drugs could be blocked through the prevention at domestic manufacturing (importing) stages. However, since 200, the improvement of standard of living, the changes of the social environment including medical care system such as separation of prescribing and
The KFDA will optimize the jurisdiction in illegal drug investigations and lead voluntary shutdown of illegal sales site of drugs. It will also emphasize that drugs being sold online are illegal or defective, highlight the illegality of online drug sales and danger of purchase online and inform the limitation of consumer's right according to Consumer Act when purchasing drugs through the internet. The KFDA will attend workshops, conferences, meetings hosted by International Medical Products Anti-Counterfeiting Task Force (IMPACT) of WHO to cooperate in the prevention of global distribution and spread of illegal or defective drugs including imitation drugs.
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5. Reinforcement in Pharmaceutical Re-assessment and Review Management Systems

The aim of the pharmaceutical review system is to prevent damages caused by adverse effects of an already approved drug, with limited approval data. Its usage record of 4~6 year period is collected to check and confirm any factors that affect its safety and efficacy. Any confirmed reaction is reflected on to the approval data for further record. In 1999, 4 years after the introduction of review system in 1995, the applications for re-evaluation have been provided, and the number of target products for re-evaluation has been increasing gradually. The critically harmful cases and reactions must be reported within 15 days from the beginning of sales, every 6 months for 2 years, and every year after 2 years to gather adverse effect information in the early stage of marketing. The KFDA improved the review system to confirm the reliability of information and established investigation methods by adding of post-marketing clinical trial data and investigating the products performance record. The administration also provided convenient review methods to the industries through the revision of guidelines that provide details on the post investigation plan, regular report and final review application. The drug review is a system that re-evaluates the safety and efficacy or its performance equality to previously submitted approval data. It goes through both document and bioequivalence re-evaluations, and the results are disclosed to medical specialists, such as doctors/pharmacists and consumers, to enhance proper use of drugs. The document re-evaluation is used to re-view the safety and efficacy of the medicine based on latest document data. The KFDA completed document re-evaluation of 177 efficacy groups and 9,453 products during first document re-evaluation period from 1975 to 1991. Since 1992, the second document re-evaluation has been ongoing. The KFDA completed the re-evaluation of 1,267 products including vitamins in 2005, 636 products including medicines for nervous system and sensory organs in 2006, 1,419 products including medicines for tissue revival in 2007, 1,478 products including X ray contrast
medium and drugs in 2008, 1,747 products including herbal medicines in 2009, and 1,365 products including medicines for the central nervous system in 2010. The bioequivalence re-evaluation examines the statistical equality of the coefficient of utilization in the living body between approved generic medicines and standard medicines (reference products). It is performed by receiving bioequivalence test plans and reporting the test results. The bioequivalence re-evaluation has been performed since 2007. The KFDA completed re-evaluations of 22 ingredients including gliclazide and 883 products in 2007, 14 ingredients including gabapentin and 381 products in 2008, 62 ingredients including nabumeton and 552 products in 2009, and 14 ingredients including nimesulide and 23 products in 2010.
6. Establishment of Management System to Prevent Narcotic Drug Abuse

1) Reinforcement of Safety Management and Establishment of Prevention System for Medical Narcotics
For the prevention of illegal distribution and proper management of medical narcotics, the KFDA expanded monitoring on such products, including propofol, with cooperation from regional KFDA and local governments. Moreover, the administration also expanded self-assessment for the narcotics traders to improve autonomous management capability and reinforce their responsibility. The robbery or loss of narcotics occurs mainly due to inappropriate managements and carelessness its handlers. The relevant authority should immediately visit the involved company to perform overall examination on storage control of narcotics and take administrative measures accordingly if anything illegal were found. Furthermore, the administration ordered the facility inspection and performed on-site training to prevent incidents occurring again. The KFDA prepared Guideline on Transport Management of Narcotics, which enforced mandatory installation of locking mechanisms and trainings for transporting workers. The guideline also specified relevant criminal charges associated with mishandling of narcotics.
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2) T he Efficient Post Control in Preventing Alterations of Narcotic Raw Materials

The precursor (raw material for narcotics) is a substance that can be used to manufacturer psychotropic drugs, classified under industrial material. The precursors are designated by a presidential decree based on the Narcotics Control Act. The KFDA designates and manages a total of 25 precursors, including 1, 4-butanediol that was newly listed in 2009. 17 materials in the first group of precursors, including ephedrine, have higher alterations possibilities and require authorizations from the KFDA commissioner upon every import and export. In both the first and the second group, the trade record of raw materials should be preserved for 2 years, and the case for the drugs which can be stolen or altered should be reported to the KFDA commissioner and the Minister of Justice. The government is participating in the international efforts to prevent illegal alteration of raw materials. Korea has joined the Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances and is reporting precursor trade status to International Narcotics Control Board (INCB) of UN every year. The KFDA also joined international raw material control program of INCB, the Project Cohesion, Project Prism, along with the Korea Customs Service in July 2006, and improved international status of Korea through the cooperation to the international efforts including participation in Data Intelligence Collection and Exchange (DICE) program to gather and share information on heroin precursors to fight against illegal drug trades. The KFDA prohibits narcotic precursors from being used in the production of illegal drugs through training, guiding and inspecting the companies trading them, and blocks the illegal inversion of precursors strictly through overall system inspection from manufacturing to distribution in the market. The KFDA performed investigations on the current status of illegal conversion for 200 companies in 2009 and hosted training for raw material traders 7 times. The administration also established cooperation systems with organizations, such as the Prosecutors' Offices, National Police Agency, Korea Customs Service and US Drug Enforcement Administration, and maintained mutual cooperative relations by exchanging information to prevent the production, import and alteration of illegal precursors to drugs, such as methamphetamine.
3) Support for Anti-Drug Campaign Center to Eliminate Illegal Drugs

The KFDA has supported public relation activities on the prevention of harmful effects of illegal drugs and rehabilitation of the addicts with Korean Association against Drug Abuse. The association was established as a juridical foundation by civil law on the basis of the Korean Pharmaceutical Association in 1992 and has been designated as a legal organization of the acts on drug control in 2002. The KAADA performed active systematical anti-drug campaigns on a national scale through 12 regional branches in Seoul, Busan, Incheon and other cities. They hosted anti-drug symposium, distributed anti-drug poster, flash animations, anti-drug UCC and cartoon contests, and anti-drug campaigns. They also performed various promotional activities through in different media, such as TV, radio, cable networks, advertisement on subway, city bus and newspaper and posters & stickers. The association carried out preventive training for elementary, middle and high school students and trained around 345 thousand of students through 4,100 training in 2010. It ran "anti-drug classroom" group consulting program for high risk teens, "Magmi peer group classroom" program to train teenagers as a leader of anti-drug campaign. They have also developed and hosted various training programs for local residents and school parents. As a result, more people have become interested in antidrug campaign. The association also hosts workshops and seminars to train specialist in local society.
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applicable to Standardized Manufacturing Process, which includes over-the-counter (OTC) drugs, cut down GMP review period from 120 to 90 days, cut down processing period to 60 days if a product in the same dosage form was being produced in the
03
Assistance in Commercialization of Pharmaceuticals
same manufacturing facility (onsite inspection exempted, sterilized products are not applicable). The KFDA allowed simultaneous validations of already approved products, lightening the burden of manufacturers. The products under Standardized Manufacturing Process were expanded to reduce costs and exempted GMP data submission for export only products, and reinforced facility standard for cephalosporin antibiotics and cytotoxic anticancer drugs to separate their manufacturing facilities. Furthermore, the administration expanded Onsite Training of Pharmaceutical Manufacturers to train on writing up validation protocols and reports. Seminars and working-level training on test method, cleaning, utilities (HVAC system, water system) and computer system validation which have been compulsory since January 2010 were held and 1 : 1 consultation became available to support the industry. In order to save expenses in drug manufacturing, import and approval, the sample for 1 test was received if for items that have no influence on testing environments based on sample amounts. Although drugs, which have been imported for the first time, must pass the examination of Research Institutes of Public Health & Environment in a city or province, there were complaints in terms of redundancy due to GMP on-site inspection for manufacturers and routine inspection for drug importers. Presently, as for the imported drugs which fall within the scope of pre-approval GMP inspection, on-site GMP inspection on overall manufacturing-quality management of foreign manufacturers can be performed instead of the pre-marketing examination. There are some problems among patients who relied on psychotropic drugs for treatment as they were not allowed to be carried during overseas trips. Also, demands for the immediate authorization through additional designation of orphan drug to supply them on time and decrease the cost spent by patients suffering from rare diseases. The KFDA designated 6 additional ingredients including citric acid and caffeine, and added infant apnea medicine as new orphan drugs in 2010 to expand treatment opportunities. The KFDA launched serviced researches on the solutions of the safety problem of marketed medicinal products and disposal of unused drugs. As a result, the agreement on the introduction of small quantity packaged drugs was drawn among related organizations such as Pharmaceutical Association and Pharmaceutical
1. Deregulation and System Improvement to Reinforce Global Competitiveness

In 2010, the KFDA discovered issues, such as promotion of fast market access of new drugs, to decrease development expenses, lowering unnecessary steps and reducing expenses. The administration also improved regulations through The Committee on Rationalization of Food and Drug Regulations, which is composed of academia, industry and consumer organizations. Also, it attended meetings with various privatepublic consultative groups and encouraged its own regulation improvement based on submitted civil complaints. The KFDA simplified administrative approval and evaluation processes if they did not influence or compromised the product quality, such as the name change in the Korean Pharmacopoeia, to enhance industrial competitiveness. This reporting is to be made once a year rather than case-by-case. Pharmaceuticals applicable to Standardized Manufacturing Process have specified ingredient type, specifications, content ratio and method of use, and should be selfmanaged by the industry rather than being subject to pre-approval GMP assessments. The introduction of product oriented pre-approval GMP inspection required improvements as it delayed the products introduction to the market. Furthermore, validation of manufacturing sites, GMP assessments for pharmaceuticals intended to export and harmonization of domestic GMP regulation to international standards were necessary. Finally, suitable policy environment to make necessary improvements were being demanded. The KFDA exempted GMP data submission and assessment for the products
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Manufacturers Association based on the agreement, 'Regulations on Small Quantity Packaged Drug Supply (KFDA notification)'. According to the regulations, over 10% of total annual output of tablets/capsules must be supplied with a small quantity package. The KFDA established Information System on Supply and Demand of Small Quantity Packaged Medicine to prepare the basis of self management of small quantity packaged medicine supply by pharmaceutical manufacturers and Pharmaceutical Association in March 2010. The KFDA also established and operated working-level consultation groups with the Korea Pharmaceutical Association, Korea Pharmaceutical Manufacturers Association and Korea Pharmaceutical Import-Export Association to consult on the contents of the system, operations, and public relations measures, and enhancement measures. The KFDA applied differential supply standards of small quantity packaged medicine to be below 10%, for 175 items, as requested by the pharmaceutical manufacturers. This was approved by the Korea Pharmaceutical Association to decrease stock expenses on small quantity package of low demand products.
1) Pharmaceutical Approval (Declared) Status of 2010

(1) General Condition
According to the analysis of the current status on drug approvals, a total of 4,115 products were approved in 2010. Since the introduction of product oriented preapproval GMP system in 2008, the number of approved products has been decreasing consistently (20% decrease compared to 5,188 products in 2009). Among finished products approved in 2010, the new drugs were a total of 48 products (including 8 products which were moved from orphan drugs to new drugs), and 45 products (94%) of these products were imported. Since Noltechs approval in 2008, the domestic development of new and incrementally modified drugs (IMD) became active. 'Kanarb' (Boryung Co. Ltd.), the 15th domestically developed drug was approved in September 9, 2010 and 8 IMD products were approved in the same year. Among the products approved in 2010, the number of declared products approved through biological equivalence was 435, and the number of products which passed the biological equivalence test was 314 (72.2%) and the number of products which passed physiochemical equivalence test was 86 (19.8%) out of the declared products. The number of products approved with the physiochemical equivalence test was 34 (7.8%),
2. Enhancement of Efficient, Transparent and Responsible Drug Approval and Evaluation

The approval and evaluation process is variable and complex, and is not easy to comprehend because the data needed for the review of safety, efficacy and quality should be changed according to drug types. Therefore, the evaluation process should be transparent and should provide an objective data as much as possible. The KFDA consistently revises Good Review Practice (GRP) on medicine of advanced countries level to systematize drug evaluation tasks and to take action for the demands on improved consistency, transparency, consideration and professionalism. The KFDA conducted product presentations, hosted meeting with related association, such as Pharmaceutical Associations, operated customized chat rooms, and hosted feedback meetings with the department of civil complaint consultations, to activate mutual communication with visitors.
and the number of products which were approved with comparative clinical trial was 1. The number of approved drug substances including DMF, human placenta medicine, and additionally designated drug substances were 123 (Guideline on Registration of Drug Substances). The number of DMF declared drug substances were 1,198, and the number of DMF declared new drug substances was 60. 146 products of additionally designated drug substances were declared (including canceled products). The KFDA established the Plan to Reformation DMF System' as a general reformation of the management system on drug substances in 2010 to improve duplicated evaluation and range of submitted data used in DMF registration and drug substances approval (registration), and perform on-site inspection based on 'Guidelines on Pre-Approval GMP inspection for Drug Substances' through the abolition of conditional DMF notification.
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(2) Approval by Major Drug Effects

According major drug effects category, the approvals for products in relation with nutritional supplements was most frequent and products for circulatory system were ranked at 4th place in 2009. In 2010, drugs related to the circulatory system, including 'high blood pressure drugs' and 'hyperlipemia drugs', were ranked first with 264 product approvals (15.6% of total items). The nervous system related products and nutritional supplement products were number 2 and 3, respectively (shown in Figure 4-?-?, diagnostic drug excluded.). This shows that the number of approvals for circulatory products through biological equivalent test was the highest in 2009. In terms of product class number, the approval of antipyretic, analgesic and antiinflammatory product (class number 114) was the majority (119 products) for 3 years, and the depressant (105 products), anti-arteriosclerotic agent (99 products), the liver disease drugs (75 products) and the gram-positive/negative virus drugs (86 products) were approved by listed order.
equivalence test to protect test subjects according to Good Clinical Practice (GCP), and to secure reliability of test analysis according to GLP. When the biological equivalence test is needed to acquire approval of generic drugs, the test plan should be approved by KFDA. In 2010, 388 biological equivalence test plans were approved. When classified by active substance, the ingredient most frequently certified by the biological equivalence test plan was glymephiride-metformin hydrochloride complex (57 approvals). The number of approvals on olmesartan medocsomil-hydrochlorotiazide complex, the high blood pressure medicine, was 46, and the number of pitavastatin calcium, hyperlipemia medicine, was 34. Biological equivalence tests for these products have been completed in 2011, and applications for approval are expected to be submitted soon. In terms of drug function, circulatory system drugs, including high blood pressure medicine, hyperlipemia drugs and antiarteriosclerotic agents, gained 150 approvals (38.7%). It can be analyzed that Korea is entering an aging society and the development of the circulatory system related drugs is increasing accordingly.
(3) Approval Review Type

From approvals of finished products in 2010, 48 products were new drugs (including 8 products moved from orphan drugs to new drugs), and of these, 45 products (94%) were imported. Since the approval of 'Noltech' in 2008, the domestic development of new and IMD was active. 'Kanarb' (Boryung Co. Ltd.), the 15th domestic new drug was approved in September 9, 2010 and 8 items of IMD were approved in 2010. From drugs and herbal medicines, the number of product approvals by data submission was 72 (including IMD). 19 of these were approved based on increased amount of active ingredient and 14 drugs approvals were made for each of the new ingredient and new dosage form.
2) Establishment of Drug Approval and Evaluation System of International Standard

(1) Operation of Good Review Practice (GRP) on Drugs
GRP is a system for transparent and predictable review tasks on drugs. It is the best measure for improving the effectiveness of evaluation tasks and negotiation strategies for both applicants and the relevant authority. The introduction of GRP can reinforce expertise through the improvement of evaluation level; provide better services to applicants; decrease expenses and time caused in the preparation of unnecessary data through providing accurate information needed for the evaluation; and decrease time of actual evaluation period by reducing reject cases. This standard improved the efficiency of evaluation tasks through the standardization by establishing review summary form standards, publishing guidelines on general considerations, task unit, and improving the quality of evaluation through standardization of review tasks. Also, reduced review period for simple data summary, and increased time for scientific analysis and in-depth assessment on review data may help to advance evaluation processes. A total of 25 GRP-SOP were enacted or revised. The newly enacted standards
(4) Approvals of Biological Equivalence Test Argets

The biological equivalence test has been compulsory on single ingredient drug among new drugs (approved since 1989) since July 1994. In 2006, the target ingredients of biological equivalence test were expanded to 507 ingredients, and the range of the target is increasing gradually. Since 2006, the on-site inspections have been performed to secure reliability of biological equivalence test. In 2007, the KFDA revised standards on biological
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in 2010 are 'Guidelines on the preparation of approval application for anticancer drugs', 'Guidelines for the assessment of on-site inspection on biological equivalence test', 'Guidelines for preparation of review application data' and 'Guidelines for preview processes on drugs.'
current status of approval and approval on biological equivalence test plan, internal guidelines, approval and evaluation result, were provided to enhance consistency and transparency of evaluation tasks and increase the predictable administrative services.
(2) T he Enactment and Revision of Evaluation Regulation and Development of Assessment Guideline
The domestic medicine evaluation regulations should be enacted or revised consistently with the consideration of the latest scientific development and international regulation from ICH. However, such regulations are not detailed or clarified, causing the KFDA define them through consistent regulation revisions. The KFDA enhanced mutual understanding between reviewers and applicants and provided faster processing of civil inquiries by explaining relevant authorities assessment methods. The KFDA released 'Internal KFDA Guideline on Approval and Review to the public in July 2006, and established 'Guidelines on the Application of Drug Approval' by summarizing regulations on approval applications, target products and necessary review factors, to prepare pharmaceutical companies. As for clinical trials, the KFDA enacted or revised a total of 6 clinical trial assessment guidelines for each disease. The guideline included explanations on planning, performing and assessing of clinical trials. It also provided factors to consider in drug development, in terms of standard selection, possible exemptions, safety and efficacy assessment variables to decrease drug development related expenses and time allocated to pharmaceutical manufacturers to perform clinical trials.
(3) Notification of Approval and Evaluation Result

Since the enactment of the Guidelines on the Notification of Evaluation Result for Pharmaceuticals in 2005, the KFDA revised this guideline regularly and disclosed target information on the KFDA website. The purpose was to support future applicants by giving examples in certain administrative service for similar applications. The targets of information notification of approval and evaluation result were for new, data submitted and drugs with added effects and efficacy. The KFDA notified information of 185 products, including biopharmaceuticals, in 2010. Information, such as
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1997, assessment systems for 6 dosage forms were introduced to simplify the KGMP. Since the designation of GMP, as compulsory requirement for finished products in 1994 and for drug ingredients in 2002, the quality of medicine has been largely
04
Establishment of Foundation for Supply of Safe and Effective Pharmaceuticals
improved. However, GMP was designated only for 7 major dosage forms, therefore, needed to be narrowed down. Although medically advanced countries carried out validations, a key factor in GMP, but it had not been introduced to Korea. For this reason, the revision of GMP standard was required. As a reference, U.S. introduced GMP in 1963, validation in 1987 and its management procedures in 1995. Japan also introduced validation in 1995. Since Korean GMP standard was not harmonized with the international standard, complications were experienced in signing MRA with other countries and in exporting pharmaceuticals. Also, deviations of quality among domestic companies also occurred. The production scale of domestic pharmaceutical industry is ranked 11th in the world, but the majorities were small companies and lacked large scale company with international competitiveness. Meanwhile, multinational companies grew bigger through M&A. The average production scale of domestic companies is only 50 billion won in 2008 and the ratio of ordinary profit is extremely low. It means that domestic pharmaceutical manufacturing companies preferred to manufacture generic medicines than new drugs as they require a larger scale of long time investment. In this condition, the KFDA introduced new GMP system to confirm the quality from raw materials to finished products and establish competitiveness compared to advanced foreign pharmaceutical manufacturing companies. The KFDA chose research projects to improve KGMP and prepared a draft in 2003 to harmonize with GMP of international organization or advanced countries. The KFDA composed KGMP revision research team and ardently reviewed since early 2004 and revised KGMP as Annex 2 of Enforcement Regulation of Pharmaceutical Affairs Act in January 15, 2008.
1. Introduction and Application of Good Manufacturing Practice of Advanced Standards

1) Purpose
In order to assure certain quality standards of pharmaceuticals, systematical management from raw materials to shipment of finished products is required. The Good Manufacturing Practice (GMP) is a set of regulation to achieve such management, hence, is essential in securing the quality of drugs. The KFDA introduced new GMP system to supply high quality drugs to consumers and enhance the competitiveness of pharmaceutical manufacturing industry by applying advance GMP. The purpose of new GMP system is to establish the quality guaranteed system for qualitative growth of pharmaceutical manufacturing industry.
2) Background
The WHO announced GMP standards during the 22nd WHO general assembly and recommended the implementation of GMP system to its member countries in 1969. Korea notified the GMP standard as Ministry of Health and Social Affairs Regulation no. 373 in the name of Good Manufacturing Practice in March 1977 and participated verification system on GMP implementation in June 28, 1969. Since then, the KGMP was stipulated as 'Good Manufacturing Practice in Annex 4 of the Article 22 of Enforcement Regulation of Pharmaceutical Affairs Act in July 1994, and as an approval requirement in manufacturing business and product items. In
3) Direction of Implementing GMP and Key Dates

The basic directions of new GMP were to acquire internationally harmonized manufacture and quality assurance management system to possess national competitiveness. This was done by reviewing relevant GMPs of U.S., EU, Japan and
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WHO. The amended was introduced in a phased manner. The pre-GMP assessment changed its orientation from dosage forms to product types and was initially applied to new and prescription drugs. Later on, manufacturing validation was applied, corresponding to item-orientation. This was to support industries in accepting changes in the regulation. In 2010, validations for cleaning, analytical method validation, utility system, and computer system were fully implemented. Now Korea completed the introduction of GMP system that is in level with other advanced countries.
5) Achievements and Assessment on New GMP Application

The first achievement of new GMP is the enhancement of GMP level through the relocation of manufacturing facilities to improve old GMP facilities and adapt new GMP system. The numbers of GMP applied facilities were 25 in 2008 when new GMP system was just introduced, 33 in 2009, and 36 in 2010. The second achievement is reinforced the structure of the pharmaceutical industry based on small quantity batch production to advanced structure based on choice and focus. The number of applications for approval of prescription drugs before new GMP system was, on average, 150 cases per month but was rapidly decreased to approximately 43 cases a month. The third achievement is the reinforcement of national capacity through domestic pharmaceutical manufacturing industry increasing their exports. This is based on enhanced of GMP management improved credit capability of domestic companies against U.S. and EU manufacturers. Today, the number of companies which passed GMP on-site inspection of medically advanced countries is 6 and is expected to be increased. The fourth achievement is the increase in the export of domestic pharmaceutical manufacturing companies. The amount of drug exports per year was 1,019 million dollars in 2007 before the introduction of new GMP system in January 2008. It increased to 1,139 million dollars in 2008 and 1,391 million dollars in 2009, subsequent to GMP implementation. When compared to the enhancement of GMP level of domestic pharmaceutical manufacturing companies, the requirement to manage advanced foreign companies was highlighted. For the EU member countries, 63 products have been approved with corrective actions, 1 product has been rejected and 16 products have been withdrawn. For U.S. and India, 39 products have been approved with corrective actions, and 2 products have been withdrawn. It shows that consistent on-site inspections for foreign companies are required. The ability of domestic pharmaceutical manufacturing companies in GMP validation has been enhanced, and the new GMP system has been stabilized. The KFDA performed inspections for 3,757 approved products, and only 18 products (0.48%) were rejected in 2009. In 2010, 4,368 products were inspected, and 4,180 products (95.7%)
4) Pre-GMP Assessments by Product Types (Items)

According to the pre-approval GMP assessment that was implemented from January 2008, the number of products applicable to pre-approval GMP assessment were small as it only applied to new drugs. Prescription drugs were added as targets in July 2008, and the average number of GMP assessments per month has been maintained to 43 until today, December 2010. The monthly average number of applications for approval was 150 before the introduction of new GMP system, but it has now decreased to 43 cases. In terms of items, a total of 1,566 products composed by 105 new drugs, 1,340 prescription drugs, 67 over-the-counter drugs and 54 drug substances applied for the GMP assessment. Contrary to initial concerns, the number of applications for approval of domestic products is larger than the imported products (Domestic: 1,134 products, Imported: 432 products). The assessment application by country were 1,134 for domestic, 94 for Germany, 86 for U.S., 44 for Japan, 39 for India, and 169 for all other countries. Among the 1,566 submitted applications, the assessments for 1,127 products are completed. 169 products have been approved without complications (with corrective actions for minor deficiencies in some cases), 883 products with corrective actions for major deficiencies and 75 products have been rejected or withdrawn. The major and minor deficiencies were pointed out throughout overall manufacturing and quality control processes, and the reasons of rejection were non-submission of the supplementary data and false entry.
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passed the inspections. It shows that the adaptability of domestic pharmaceutical industry to validation processes has been improved, and new GMP system is well implemented without many complications.
products including dextrin. The Supplement 3 was published as a KFDA notification 2010-27 (May 3, 2010). The KFDA added purity tests in recorded products to establish reasonable management system and revised to meet latest scientific advances and international trends. The previous revision was published in 2009 to correct some imperfections on operational
2. International Harmonization to Achieve Advances in Pharmaceutical Safety Standards

In order to supply high quality drugs and quasi drugs, the KFDA has been establishing a drug safety control system at international standard revising domestic standards and specification of raw materials and pharmaceutical products. The KFDA revised the Korean Pharmacopoeia and the Korean Pharmacopoeia for Quasi-drugs. Antibiotic Standards was incorporated into above pharmacopoeia and subsequently abolished. Furthermore, The Designation, Standards and Testing Methods for Tar Coloring for Pharmaceuticals, Quasi-drugs and Cosmetics was partly amended after the review of relevant standards and test methods of other countries. The standard and specification for drug quality are being upgraded accordingly to match the scientific development by conducting researches on drug safety control, drug evaluations, and quality assurance issues from various sources, including the national assembly. The quality standard can assure the publics trust in drug qualities and help to raise the competitiveness among domestic pharmaceutical industries.
conditions. The main revisions of this supplement are the establishment or the reinforcement of purity test on heavy metals and microbiological criteria for 95 products, including thyroid sicca, rotation test for diltiazem hydrochloride and amikacin sulphate, addition of limit standard and inclusion of test method on coumarin in the definition and quantitative method of cinnamon oil. The purity test of ethambutol hydrochloride and identification test of pravastatin sodium were removed, and the range of target microbial strains for sterility test, criteria test, preservation test, final sterilization and sterilization index in general tests were expanded. Also, 'powder X ray diffraction method' was added to the general test method.
2) 3rd Edition of the Korean Pharmacopoeia for Pharmaceutical Products

The 3rd revision the Korean Pharmacopoeia for Pharmaceutical Products was published on May 1st, 2007 to specify raw materials and pharmaceutical products specifications. It also considered current trend in drug development, domestic situation for drug distributions and international regulatory harmonization. Its supplementary section that went through 5th revision was also notified. In 2010, 6th edition of the supplementary section was published, containing updates on projects for pharmaceutical safety standards advancements, herbal medicine reassessment of 2008~2009 and overall revisions in notifications. It also revised standards and testing methods of purity test on 55 products including glutathione, added 6 items in antibiotic standards, described testing methods for herbal medicines, and modified the listed items (2 items added, 7 deleted). Meanwhile, the test method for insecticide was reorganized into Standards and Testing Methods of Quasi-drugs after being separated from Standards, Specification and General Testing Method for Insecticides and Quasi-drugs.
1) 9th Edition of the Korean Pharmacopoeia

The 9th edition of the Korean Pharmacopoeia was published in December 28, 2007. In 2009, the standard of talc revised as Supplement 1, and enhancement of standard on medicine was launched. The standard of 71 products, including heparin sodium, was published as Supplement 2 (the KFDA notification 2010-10) in February 24, 2010. The main revisions of Supplement 2 constituted of standard on related compounds (impurities), microbiological criteria and standard of heavy metals for 24 products (incl. heparin sodium), made improvement in content test of major ingredients in 8 items including doxorubicin hydrochloride, and reinforced of heavy metal standards for 6
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Table 3-4-6 Current Statistics of Products Included in Drug Standards of Korean Pharmacopoeia
Type number of products NonHerbal prescription medicine medicine 1,440 574 Radiopharmaceutical 43 External diagnosis medicine 36 Drug additives 15 total 2,108
were inappropriate and removed from the list, and 11 colorings for external use were limited to quasi drug only. The mixture limit of tar colors was decided to be set below 0.1%, considering medicine manufacturing guideline of Japan. If tar colors are used over 0.1%, a separate review is required.
3) D esignation, Standard and Testing Method of Tar Color for Pharmaceuticals, Quasi-drugs and Cosmetics
The Designation, Standard and Testing Method of Tar Color for Pharmaceuticals, Quasi-drugs and Cosmetics was established by the Minister of Health and Social Affairs Notification No. 87-42 to classify tar colors for use in drugs, quasi-drugs and cosmetics and establish their standards and test methods. It has been continuously updated to secure the quality and adapt to international trends. The standard and specification of EU, U.S. and Japan was investigated in 2008~2009 and the revision was published based on the investigation. It became KFDA notification no. 2010-32 (May 14, 2010). It established purity test for mercury, heavy metals, zinc and iron in 42 tar colors including red 3 from Table 4, changed mercury and other 4 test from Table 5, and developed a method to conduct acetate ammonium solution test for 15 products including red 2 (amaranth). Also, Table 2 and 3 were partly amended. Meanwhile, the general audit of health and welfare committee in the National Assembly pointed out safety concerns on tar colors for medicine, including iron products distributed for free from health centers to pregnant women, and consumer organizations and media also pointed out safety concerns of tar colors. Hence, relevant divisions of KFDA discussed control method of tar colors. Among the 76 tar colors authorized for use in drugs and quasi drug, some are not used advanced countries for safety reason and some, such as tar color mixture ratio, are lacking dosage standards. Thus, the removal of inappropriate colors was discussed to refine the relevant standards. Korea Pharmaceutical Association and Korea Pharmaceutical Traders Association investigated tar colors by checking their usage and referring to standards of U.S. and EU. The review showed that 17 tar colors
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international cooperation is becoming crucial to handle international medical safety problems, such as the spread of H1N1 virus and heparin pollution.
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International Cooperation in Pharmaceutical Sector
2. Current Status in International Trade and Cooperation

1) Current Status
The Ministry of Foreign Affairs and Trade, the Ministry of Health and Welfare and the KFDA are responsible for international trade and cooperation. The Ministry of Foreign Affairs and Trade manage general international cooperation and trade related tasks such as the FTA. The Ministry of Health and Welfare engages in international cooperation and trade related tasks in health and welfare by the international cooperation agent and the trade cooperation attach, and the health and medical policy department support drug related tasks. The international cooperation and trade related task organization of the KFDA is examined by the International Trade and Statistics Office under the Office of Planning and Coordination and food and drug officers at Korean Embassy in China and U.S. supports the administration. The actual analysis, strategy, consultation and execution of major trade and international cooperation, such as the FTA of drug area, have been mostly managed by the Pharmaceutical Safety Policy Division. In the beginning of the Korea-US FTA in 2007, the KFDA installed and operated the reinforcement of competitiveness task force in the Pharmaceutical Safety Bureau (activity ended in April 2008).
1. Pharmaceutical Products and Globalization

The domestic drug market is one of the markets from in the medical health care that opened early, and has been critically influenced by globalization. The drug import was liberalized in the 1980s and the capital investment for drug manufacturing was opened in 1990s, allowing active and direct market access by multinational pharmaceutical companies. As insurance payment between imported and domestic manufactured drugs does not differ, the multinational pharmaceutical companies have expanded their market share continuously by introducing new drugs. Since the IMF crisis, the globalization strategy of multinational pharmaceutical companies has led to the decrease of domestic investment in facility development and they moved most manufacturing facilities to China in early 2000s as they offer relatively cheaper labor costs. There were many changes in a safety management of medicines as well as in trade and investment. Most especially, the KFDA, which was established in 1998, started to build an internationally harmonized system on overall areas from drug approval and review to implement safety control during IMF crisis, and in the late 2000's, they have established internationally harmonized regulation systems in many fields. In the era of limitless competition, the establishment of mutual dependability and reciprocal relations with countries possessing export markets and resources is essential for national security and survival of a nation. The international harmonization and cooperation in researches through international organizations such as ICH and APEC are necessary. Nowadays, the establishment of a fast and widespread action system through
2) International Cooperation
(1) I nternational Conference on Harmonization Global Cooperation Group (ICH-GCG)
The ICH was established by U.S. (Food and Drug Administration), Japan (Ministry of Health, Labor and Welfare) and EU (European Medicines Agency), the leading countries of new drug development and pharmaceutical industries (EFPIA, JPMA, and PhRMA). The ICH is a committee that has been developing international standards by the publication of ICH guideline for the past 18 years. The observers of ICH are WHO,
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European Free Trade Association (EFTA) and Health Canada. They have a role as a link between ICH members and non-ICH members. Korea is involved in ICH-GCG from ICH tasks. The ICH-Global Cooperation Group (ICH-GCG) is a subcommittee of the ICH Steering Committee and established in March 1999 to involve other interested parties. The ICH-GCG is an organization composed by ICH associated countries, ICH secretariat and associated countries of Regional Harmonization Initiatives (RHI), Drug Regulatory Authorities (DRAs)/Department of Health (DOH). Around 30 people participate in the assemblies every 2 years. Korea has been also participating in the ICH Regulators Forum established in November 2008, composed of regulation authorities of ICH-GCG associated countries. Its aim is to help countries without ICH membership on the application of ICH guidelines and share and discuss issues experienced by regulatory authorities. This forum is an organization composed by the Regional Harmonization Initiatives (RHI), Drug Regulatory Authorities (DRAs)/ Department of Health (DoH) members among ICH associated countries. Around 15 people participate in the assembly every 2 years. Korea has been gathering information on international conditions of ICH Q7 (GMP), ICH E6 (GCP) and GRP, and newly participating authorities are Brazil and China and member countries. In 2009 (October 28-29, 2009), Korea participated in the ICH Steering Committee assembly to discuss the safety assessment on anticancer drugs laboratory safety assessment of biopharmaceuticals development and manufacturing of drug substances clinical assessment of antiarrhythmic drugs gene-therapeutic drugs and assessment of Pharmacopoeia. The ICH Steering Committee is composed by ICH associated countries (the governments of U.S., Japan, EU) and pharmaceutical industries (EFPIA, JPMA, PhRMA). The committee grants 2 representatives of each country and pharmaceutical industries (total 12) to the committee meetings. There also is the ICH secretariat and WHO, EFTA, Canada (Health Canada) as observers. The main Steering Committee discusses and approves every ICH activities. In 2010, the KFDA is inviting a specialist from ICH associated countries such as U.S. (FDA), Japan (Welfare Ministry) and EU (EMA) to become a member for the KFDAs the advisory committee on drug adverse effects. Korea is to participate in expert working groups (Environment Working Group and International Working Group) as a member of ICH-GCG.
(2) D irector-General Level Consultation on Pharmaceuticals between Korea-China-Japan

Planning At the meeting of Korean-Chinese-Japanese Ministers of Healthcare in April 2007, the cooperation on development of medicine in Asia was agreed and the DirectorGeneral level meeting was organized as a follow-up task. The first meeting was held in Tokyo, Japan in April 14, 2008 and SFDA of China, Ministry of Health, Labor, and Welfare of Japan and the KFDA agreed to launch the Joint Research Project on Ethnic Factors in Clinical Data, start information exchange scheme on medicine, and organize its working group. The working group of Korea-China-Japan was held, in August 2009, to finalize details discussed in the meeting at Japan. 3 countries tried to establish Terms of Reference (TOR) to draw details of general manager meeting but could not discuss deeply because China insisted to limit the area of the meeting to clinical test area only, unlike the result of the first general manager meeting. The 3 countries agreed on the establishment of TOR for the working group, the coordination of Japan on Research on Ethnic Factors and designation of principal researcher from each country. However, they could not agree on the comparison of regulation system on overall medical system and general information exchange. The second director-general level meeting was hosted in Beijing, China in December 17, 2009. The second meeting aimed at the arrangement of past discussions and agreement of issues that the parties failed to agree on at the previous workinggroup. In this meeting, the 3 countries agreed to the details of the Joint Research on Ethnic Factors in Clinical Data (managerial regulations, TOR). For Research on Ethnic Factors, Japan is to coordinate the project. The process order of the project was agreed as the draft of Japan Discussion of the expert group Working group Discussion of director-general meeting. They agreed to operate expert group composed by representatives of academics of each country, and aimed for project completion by 2012. The 3 countries agreed to information exchange on clinical area, and Korea is to coordinate clinical trial information exchange. Korea will write a draft to develop clinical trials and each country is to review and discuss the draft. The third director-general level meeting was held in Seoul, Korea during September
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2010. In this meeting, 3 countries shared the progress since the assembly of the Korea-China-Japan ministers of health care in 2007. The meeting also established a base article on operation of scientific research among working groups. For the Research on Ethnic Factors, Korea-China-Japan established a concept paper to described detail and plan of the research. The research group is a scientific discussion group that offers opinions to the working group and is composed by a maximum of 6 members from regulation authorities. The PR and liaison officials are assigned among the members. For the information exchange for the scope of clinical trials, Korea will prepare a comparative table of clinical trials system layout with the cooperation of each country and compose a concept paper on the basis of the table. They agreed that the establishment of MCRT guideline by research group (China), the regulation harmonization on joint GCP inspection (Korea) will be discussed in future meetings.
Committee and organization and launching of Korea-China Drug Approval and Evaluator Committee.
(4) APEC Harmonization Center (AHC)

The 'harmonization initiative' of Korea was selected as an official agenda of Life Science Innovation Forum (LSIF) steering group in February 2008 (discussed in Senior Official's Meeting (SOM) , , February 5, 2008). Korea suggested stable support of training on international harmonization of medicine and medical device regulation through the establishment of an APEC international harmonization training center in Korea and the acting chairman of LSIF steering group (Dr. Diane Hannemann, US Department of state) requested members to support the APEC fund. The KFDA agreed to support the establishment of AHC and allocated 200 million won for autonomous research and development and 500 million won for service research issues. The KFDA announced supporting and operation plan for the third APEC Senior Official's Meeting (SOM ) in July 2008 while AHC establishment in Korea is unofficially decided. The AHC establishment in Korea was announced in a joint declaration of APEC ministers meeting in November 2008 and was approved during the APEC summit. ICH agreed to cooperate on program development at the ICH regular general assembly in Brussels, Belgium. The APEC regulation harmonization center guideline was subsequently agreed upon through several discussions, and the 6 symposiums and workshops on the multilocation clinical trials and drug supply chain management were held since opening in July 2009.
(3) K orea-China MOU and Operation of Working-Level Consultative Group in the Drug Area
This consultative group was organized by The cooperation contract on food, drugs, cosmetics and medical devices between the KFDA and the department of national food and drug control of the People's Republic of China in April 2009. According to this contract, the working group has been organized for each of the specialized area and support tasks of higher level consultative groups. The principle of the installation of working level consultative groups is 4, looking into a scope for drugs (including herbal medicine), cosmetic, medical devices. However, higher level consultative groups can change the organization. According to the decision of higher level consultative groups, the working group meeting will be hosted every year and the representatives of the groups are director generals of each organization. If it is needed for operational conditions, the consultative groups can invite private experts or related person of import/export companies. For the efficient operation of the consultative group, Korea and China can designate a liaison officer of their own. The second Korea-China senior conference and medical working level consultative group was hosted in Seoul, July 26, 2010. In this meeting, both countries agreed to the mutual launching of Korea-China Approval and Evaluation Symposium for Pharmaceuticals, the continued operation of Korea-China Drug Quality Standards
(5) Supporting Official Development Assistance

The Korean government decided to be in involved in ODA for 8 major developmental sectors with high demands for support in developing countries. For Public Health Sector, which includes medicines, the government began to find suitable projects with the consideration of Koreas national capacity in the field.
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Chapter 05

01 Conditions and Prospects of Biopharmaceutical Products Administration 02 System Management of Biopharmaceutical Quality Assurance 03 Fostering the Biopharmaceutical Products and Building the Foundation of Support System 04 Safety Management of Human Tissue 05 Reinforcement of Safety Management Infrastructure for Medicine and Herbal Medicine 06 Establishment of Management System for Cosmetics and Sanitary Aid
1. Conditions and Prospects of Biopharmaceutical Products Administration 2. System Management of Biopharmaceutical Quality Assurance 3. F ostering the Biopharmaceutical Products and Building the Foundation of Support System 4. Safety Management of Human Tissue 5. Reinforcement of Safety Management Infrastructure for Medicine and Herbal Medicine 6. Establishment of Management System for Cosmetics and Sanitary Aid
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Table 5-1-1 Top M&A of Biopharmaceutical Companies in 2008 and 2009

Taken over by Pfizer Roche Merck & Co. Gilead Sciences Takeda Eli Lilly Daiichi-Sankyo Nordic Capital Fresenius Kinetic Concepts King Shionogi Novartis GSK Target Wyeth Genentech Schering-Plough CV Therapeutics Millennium ImClone Ranbaxy Convatec App Pharmaceuticals Lifecell Alpharma Sciele Speedel Sirtris The value of being taken over (a number in the million dollar) 68,000 46,800 (Remaning Roche Genentech 44% shares) 41,000 1,400 8,800 6,500 4,600 4,100 3,700 1,700 1,600 1,100 880 720 The Year taken over 2009 2009 2009 2009 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008
01
1) Outline
Conditions and Prospects of Biopharmaceutical Products Administration
1. The Domestic-Global Trend of High Tech Biomedicine
Bio-Industry, which directly utilizes the biotechnology including DNA, protein, cells for production and service has been evaluated as the new industry that will take the lead of 21st industrial growth in the fields of medicine, chemistry, environment, food, energy, agriculture and marine. It is most actively applied in medical biotechnology (Red Biotechnology, Red BT), although its value is being heavily considered in both agricultural biotechnology (Green BT) and industrial biotechnology (White BT), as well. To overcome the limitations of existing new synthetic drugs, the multinational pharmaceutical companies which focus on synthetic chemical medicines like Pfizer and Merck, are actively entering into the field of bio medicine through the M&A and alliance. The Korean government is also making an effort to set a budget for supporting the development of new biopharmaceutical products of high values by establishing relevant guidelines.
Reference: Frost&Sullivan, Pharmaceuticals & Biotechnology
After the establishment of Biotechnology Support Act in 1983, Korea began the promotion of methodical researches and developments of bio-technology, and built the mechanical infrastructure according to the first Basic Plan for Biotechnology Support (1994~2006). From 2007 to the next 10 years, Korea is also planning to promote essential tasks on each of the 8 relevant ministries for the industrialization of advanced medicines. The second Basic Plan for Biotechnology Support (2007~2016) is aiming place Korea within the top 7 countries with expertise in Biotechnology.
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Figure 5-1-1 Project Planning for the Industrialization of Advanced Biopharmaceuticals

Research policy and system maintenance Achievements in biotechnology research Visualization of the research results
Growth engine industry of the next generation: new biopharmaceutical products and long-term business projects (2004) 13rd 14th 12 new drug (accumulated) 7th
% of top 100 drugs Biotechnology Conventional

Enter into Bio G7 powers
11% 89%
28% 72%
50% 50%
Reference: Evaluate Pharma Report (June, 2009)
Koreas rank in publishing scientific papers (SCIE standard) Koreas ranks in possessing experts (USA patents standard)
Basic plan to promote brain research support (1998)
The leader of advanced biopharmaceutical products is Recombined Medicines, which are produced by the gene recombination technology. It currently takes up 10% of the worlds pharmaceutical market since its introduction in 1982. After the birth of Dolly the sheep at Roslin Institute in1997 and the completion of Human Genome Project by the U.S. in 2000, gene therapy and cell therapy products are in the spotlight as the second leader of biopharmaceutical products. vanced biopharmaceutical products have shown a great growth through the cardiovascular medicines, such as EPO (erythropoietin) and TPA (tissue plasminogen activator), and cancer medicines, such as CSF (colony stimulating factor), interferon and interleukin. More products are being developed to treat immunological and respiratory diseases, and research on incurable diseases is also in progress. As the patent of the first generation advanced medicines, such as insulin and human growth hormone products, are about to expire, the biosimilar market is expected to formed in US and Europe. The patents of gene recombined protein drugs that were released in the late 1980s have or will expire in the next few years. Table 5-1-3 Patent Expiration of Major Advanced Pharmaceutical Products
No Name of the product Enbrel Epogen Remicade Avonex Rebif Humalog Neupogen Ingredient Company Symptom Market breadth* Expiration year (a number in of the patent the thousand (U.S.A. patent) million dollor) 5.0 5.3 4.4 1.8 1.6 1.4 1.2 2012 2013 2013 2013 2013 2013 2013
First basic plan for biotechnology support (1994) 22nd 29th 21st
15th
17th
94 96 1st stage (1994~1997)
98 01 2nd stage (1998~2001)
BT venture business boom (approximately 500 established)
03 05 3rd stage (2002~2006)
~16
Reference: Second Basic Plan for Biotechnology Support - 2007~2016
2) Trends in Development of Biotech Medicines

(1) Global Trend
Medicines using Biotechnology are largely classified into genetically modified medicines, gene therapy products and cell therapy products, and the most active developments are being made in genetically modified medicines. The growth rate of the pharmaceutical market is slowing down although the size of the biopharmaceutical product market is expanding. It is expected that the biopharmaceutical product market will grow to 23% by 2014 from 17% of 2008. Table 5-1-2 Medicine Sales Report for Each Technology Fields (by Year, a Number in the Thousand Million Dollor)
(unit : billion dollars, %)
1 2
Etanercept Epoetin alfa Infliximab The interferon beta-1a The interferon beta-1a Insulilispro Filgrastim
Amgen Amgen Johnson & Johnson The biogen Idec Serono Lilly Amgen
Rheumatoid arthritis Anemia Rheumatoid arthritis Multiple sclerosis Multiple sclerosis Diabetes Neutropenia
Sales by Technology($bn) Biotechnology Conventional Other Unclassified Sales Total Rx & OTC Sales % of total Rx & OTC sales Biotechnology Conventional/Unclassified
Analysis of Sales by Technology 2010 2008 28 108 222 408 60 127 310 643 9% 91% 17% 83%
2014 169 406 163 738 23% 77%
3 4 5 6 7
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No
Name of the product Cerezyme Copaxone Rituxan
Ingredient
Company
Symptom
Market breadth* Expiration year (a number in of the patent the thousand (U.S.A. patent) million dollor) 1.1 1.6 4.5 2013 2014 2015
the clinic tests for dendritic cells, activated lymphocyte and cord blood stem cell. Table 5-1-4 Current Status on the Approval for Advanced Biopharmaceutical Products
Divition Cell Theraphy Products DNA Chip Genetically recombinant medicine Total 11 6 199 2001 1 0 12 2002 1 0 27 2003 0 0 31 2004 0 2 13 2005 1 0 16 2006 1 1 13 2007 6 2 30 2008 0 0 35 2009 1 1 22 2010 4 1 5
8 9 10
The Imigeulru cerase Glatiramer acetate Rituximab
Genzyme Tebar Genentech
Gaucher disease Multiple sclerosis Non-Hodgkins lymphoma The leukocyte promoting improvement Diabetes Rheumatoid arthritis Breast cancer Colorectal cancer Macular degeneration
11 12 13 14 15 16
Neulasta Lantus Humira Herceptin Abastin Lucentis
Peg filgrastim The insulin Glargine Adalrimumap Trastjumap Bevacizumab Ranibizumab
Amgen Sanopiabentis Abbott Genentech Genentech Norvatis
3.0 2.7 3.0 4.0 3.4 1.2
2015 2015 2016 2019 2019 2019
According to the Korea Institute for Industrial Economics and Trade (KIET), domestic advanced biopharmaceutical products are expected to have an annual average growth of 19%, based on production rates, and form a 13.9 billion valued market, which is higher than the estimated average growth rate for the world.
* Reference: Evaluate Pharma: Company Reports, 2007
2. Domestic and Foreign Trend of Vaccine Industry

1) Outline
A vaccine is a biological preparation that contains an agent that resembles diseases, such as microorganism, and is often made from weakened or killed forms of microbes or their toxins, to improve immunity to a particular disease. Vaccines can be prophylactic or therapeutic by the purpose of use. Prophylactic vaccines prevent or ameliorate the effects of a future infection by inoculation of any natural pathogen, revitalizing the immune system. Therapeutic vaccines are an advanced concept vaccine, which destroys the virus or tumor cell in the body by revitalizing the immunomechanism that affects such cells. Vaccines of the past were mainly single vaccines for rubella, smallpox, poliomyelitis and hepatitis. Lately, the polyvalent vaccine is gradually expanding its range. Also, innovative products, including vaccines for cancer, AIDS, avian influenza and anthrax, are in the research and development (R&D) phase.
Gene therapy products, which insert the genetic material into the body, are being studied for the purpose of curing genetic diseases although is only in the clinical trial test period. Recently, China permitted Gendicine, the medicine for head and neck cancer, in 2004. The value of the genetic therapy market was 350 million in 2005 and is expected to grow to 59.19% between 2005~2010. In 2010~2015, it will reach 29.9%, market size being estimate to be 13.4 billion dollars. (Reference: Biotech Information Potal, July, 2007)
(2) Domestic Trend

Chondron, which is the medicine for chondrocyte, is the first advanced biopharmaceutical product that received an approval for the clinical trial on January 30th, 2001. Genetic clinical trials of therapy products were approved in May 3rd of the same year. Recently, the development of customized medicine is being accelerated through item approvals of Skin Keratinocyte and DNA Chip, and general approvals of
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2) Trend of Vaccine Development

(1) Global Trend
International vaccine developers are expanding their business to the market of advanced concept vaccines that incorporate advanced biotechnology. They also appear to be making good results of vaccine developments for lethal diseases, including AIDS, malaria, anthrax, cancer, Alzheimer's, hypertension, diabetes mellitus, asthma and atherosclerosis along with the existing prophylactic vaccines. Promising vaccines for HIV, SARS and anthrax are also expected to be released in 3 years time. The field of vaccines for children, which is leading the present market, is expected to carry the same weighting by improving product formula and effects, but it is also predicted to be behind the field of vaccines for influenza or cervical cancer that is actively developing new products.
terrorism, while Dong-A Pharmaceuticals is establishing a consortium with Daewoong, Genexine, and Pohang University of Science and Technology for the commercialization of HepB DNA vaccines and is conducting clinical trials on AIDS DNA vaccines in cooperation with Genexine. Table 5-1-5 Current List of Clinical Trials for Major Vaccines and Plasma Derivatives
Company Product GC1102 Green Cross MG1109 Green Cross GC1109 Green Cross GC1107 MSD-Korea Sanofi Pasteur Korea Dong-A V710 Inj Pentaxim Inj HB-110 Dong-A GX-12 Ingredient Recombined HepB immunoglobulin Avian influenza vaccine Recombined Anthrax vaccine (Absorptive) Td vaccine for adult Staphylococcus aureus vaccine DTaP-IPV-Hib combined vaccine HBV antigen gene expression Plasmids HBV antigen gene expression Plasmids Note HepB Prevention of Avian influenza Prevention of Anthrax Prevention of Tetanus and Diphtheriae Prevention of Staphylococcus aureus infection Combined vaccine DNA vaccine to treat HBV patients Treatment for HIV pateints
Green Cross
(2) Domestic Trend

Major Korean pharmaceutical and biotechnology companies, which leads the domestic vaccine market, are also vigorously concentrating on the pharmaceutical developments, reciprocating the global trend. Berna Biotech Korea, who succeeded in developing the worlds third Hepatitis B (HepB) vaccine, has released the HepB vaccine that is Thimerosal (mercury) free since 2004. Also, for the first time in korea, it received an approval to develop and export Quinvaxem Injection, a vaccine that prevents Diphtheriae-Pertussis-Tetanus (a.k.a. DTwP), HepB, and Type B Haemophilus influenza (Hib) in one inoculation. LG Life Sciences has developed a second-generation HepB vaccine (Euvax-B) for the first time in Korea. It acquired approvals for DtaP-HepB combined vaccine (Eutravan) and Hib vaccine (Euhib Inj) in 2008 and 2010, respectively. LG also has developed the combined vaccine of DTaP-HepB and Hemophilus influenza type B. In 2009, Green Cross built a facility at Hwasun-gun, Jeonnam, to manufacture vaccines for varicella, Japanese encephalitis, hemorrhagic fever with renal syndrome, tetanus and influenza, from an undiluted solution. This means that Green Cross developed the influenza vaccine with its own technology, rather than relying on import. It is now developing vaccines to prepare against pandemic influenza. Korea Vaccine is currently in the R&D phase of an anthrax vaccine against bio-
Table 5-1-6 Vaccines Development and Sales (by Company)

Company LG Life and Sciences Development and Sales Sales of HepB vaccine (gene recombination), Influenza vaccine, Combined vaccine (DTP + HepB) and Hib vaccine Development of DTP + HepB + Hib combined vaccine Sales of Varicella-Zoster vaccine, Hemorrhagic fever with Renal syndrome vaccine, DTaP vaccine and etc. Development of Td vaccine for adult, Anthrax vaccine and Avian influenza vaccine Sales of HepB vaccine, HepA vaccine and Influenza vaccine Development (5 polyvalent vaccines) and supply of combined vaccine (DTP + Meningitis + HepB) to WHO Sales of Influenza vaccine Promoting the clinical trial of AIDS DNA vaccine and HepB DNA vaccine
Green Cross
Berna Biotech Korea
Dong-A
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Company Boryung Biophame CJ SK Chemicals Korea Vaccine
Development and Sales Sales of Influenza vaccine, Japanese encephalitis vaccine, Hib vaccine, Typhoid fever vaccine and etc. Development of Td vaccine for adult Sales of Influenza vaccine, Smallpox vaccine and etc. Sales of HepB vaccine, Influenza vaccine, Japanese encephalitis vaccine, Typhoid fever, DTaP vaccine and Hib vaccine Sales of Influenza vaccine, DTaP vaccine, Typhoid vaccine, Polio vaccine, HepB vaccine and etc. Development of Anthrax vaccine
1. C onditions and Prospects of Biopharmaceutical Products Administration 2. S ystem Management of Biopharmaceutical Quality Assurance 3. F ostering the Biopharmaceutical Products and Building the Foundation of Support System 4. Safety Management of Human Tissue 5. Reinforcement of Safety Management Infrastructure for Medicine and Herbal Medicine 6. Establishment of Management System for Cosmetics and Sanitary Aid
02
1. Outline
System Management of Biopharmaceutical Quality Assurance
3. Prospects of Biopharmaceutical Products

By 2020, the growth of domestic biopharmaceutical products is expected to be 19% in terms of compound annual growth rate (CAGR) on a production basis, and form 13.9 billion dollar market. It is also expected to exceed the growth rate of 14%, which is the average annual growth rate of worlds market. The top 5 countries, including, US, Europe and Japan, take up 81% of worlds market for biopharmaceutical medicine industry. Koreas market share in the worlds is expected to grow from 1.4% in 2005 to 2.7% in 2020, showing the nations steady growth in the market.
Biological products like vaccines are being frequently used in social classes that exhibit vulnerable dispositions, such as children. Since biological products safety and efficacy are immeasurable by physical and chemical testing as they are manufactured from materials deriving from living organisms, their quality management is much more difficult than general medicines produced from chemicals. Therefore, the steady management of quality is necessary. The Korea Food and Drug Administration (KFDA) is planning to improve the current system of national testing for biological products that are distributed domestically by applying lot release testing system of advanced countries, which focuses on the finished product. This is to strengthen the quality assurance system for and promote safe distribution of biological products. The KFDA requested for the revision of the Enforcement Regulation of Pharmaceutical Affairs Law, to unify standards for imported plasma and set legal basis for Plasma Master File System and look-back procedures. The administration is also establishing regulations for Plasma production, quality management and reporting, as a preparation for an upcoming revision of the above law. The KFDA is also establishing a safety management system for biopharmaceutical products that derive from human and animals being developed in large quantities.
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2. Improvement in Management System of Pharmaceuticals Subject to National Testing

Biological products are organic compounds that cannot be defined like a chemical. Due to its natural variability, it needs to be meticulously managed to maintain the quality. Countries like the U.S., Europe and Japan took an account of such characteristics and established a principle to conduct national testing on biological products. To increase the level of quality management and strengthen the competitiveness of national manufacturers, the KFDA is improving relevant regulations. It implemented the national lot release testing system, which is being practiced by other advanced countries. The relevant amendment was made to the Pharmaceutical Affairs Law in June, 2011 and is to be enforced from June, 2012. The national lot release system is to give an approval for the product release after a comprehensive review of the entire manufacture and quality control procedures of biological products. Specifically, the aim is to expand the application range of manufacture and quality control protocols to the entire products categories, advancing the national testing system. The KFDA is also planning to implement national testing certificate labelling system as an alternative measure to lighten the burden of the industry. Table 5-2-1 Current Status for Pharmaceuticals Going through National Testing
Division Number of National Testing (2010) Total 1,597 Microbial vaccine 306 Virus vaccine 562 Plasma derivatives 729
tests on imported plasma products and amended the relevant management standard for regular inspection of the exporting companies. The KFDA is also running a testoperation of Plasma Master File (PMF) System with the Korea National Red Cross. The PMF system enables the documentation of manufacturing and storing processes of plasma derivatives from the initial stage of blood donations. Last year, mandatory application of PMF system was extended to imported plasma. Currently, the revision of the Pharmaceutical Affairs Law is underway to combine separate standards of domestic and imported plasma products. The pharmaceuticals derived from human placenta is not currently considered as biological products. However, they are being managed as biological products by the Biopharmaceuticals and Herbal Medcine Bureau of KFDA since Nov 23rd, 2005, as they were deemed necessary to be applied with an appropriate level of management.
4. Establishment of a Definition for Biological Products

Although pharmaceuticals from living organisms are being constantly developed, there is no clear definition available for pharmaceutical products deriving from living organisms in the Pharmaceutical Affairs Law. Thus, the KFDA created definitions for both biological and biosimilar products during the revision of Item Approval and Evaluation Regulation for Biological Products (KFDA notification). Biopharmaceutical products are made of the raw materials or materials derived from human or other living organisms. It also means that the they require extra caution in terms of sanitation. It includes biological products, genetically recombinant medicine, cell-culture medicine, cell therapy product and gene therapy product or any other type that was approved by the Commissioner of the KFDA. Biosimilar is a term used to describe a biological product that has already received manufacture/
3. Establishment of the Safety Management System for Plasma Derivatives and Pharmaceuticals Derived from Human Placenta
The first requirement to consider in securing the safety of plasma derivatives is the system to provide raw materials that are not infected with pathogens such as virus. For that, the KFDA made it an obligation to conduct polymerase chain reaction (PCR)
sale/import approvals additional to the confirmation of quality, non-clinical and clinical equivalency with its innovator product.
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projects were to revise current approval and evaluation system through regulatory improvements and policy reforms.
03
1. Outline
increasing.
Fostering the Biopharmaceutical Products and Building the Foundation of Support System
1) Improvement of the Assessment System for Advanced Biopharmaceutical Products that Utilizes New Technologies
The necessity of the assessment guideline to evaluate the safety and efficacy of biopharmaceuticals according to its characteristics has been continually propounded. Hence, the KFDA published a total of 85 guidelines; 18 in 2005, 14 in 2006, 14 in 2007, 20 in 2008, 8 in 2009 and 11 in 2010, contributing to the development of advanced biopharmaceutical products. Since 2008, the KFDA opened the Guidelines information center for the biopharmaceutical products section on its home page, offering the easy retrieval of existing data. Also, the administration enabled the public to suggest guidelines or submit opinions to strengthen two-way communication, while disclosing the progress of the guideline development for transparency and objectivity. After publishing 85 guidelines from 2005 to 2010, it is now planning to publish another 7 guidelines in 2011 to support the development of new products.
Recently, bio-industry was selected as a growth engine industry for the next generation. Therefore, demands that KFDAs mission should be expanded not only to the safety management but also to policy development for industry support, is Consequently, the Biopharmaceuticals and Herbal Medicine Bureau is converting its management style as a regulator to a customer-focused management practice for the productization of advanced biopharmaceuticals. It will also expand current policies to provide wider supports for R&D of new drug products.
2. Innovation of the Customer-Focused Evaluation

In April 2007, the KFDA received positive results on the improvement of biopharmaceutical product approval and evaluation system, through the running of 12 innovation projects. Since then, the administration planned more projects with a similar objective. In 2008, 8 projects, including the 'Simplification of Standards and Test Methods Evaluation Data for Imported Biological Products, in 2009, another 8 projects, including the 'Simplification of Stability Testing Data when Biological Product Manufacturing Method is Altered, and lastly, in 2010, 5 projects, including the 'Reorganization of Efficient Approval and Evaluation System for Vaccines prepared for Emergencies such as National Pandemic and the 'Expansion of Evaluation Targets for Efficient Approval Support for Biological Products were carried out. All the
2) Preparation of Approval and Evaluation Standards for Biosimilar Products

Biosimilar is a product that adopts the concept of generic medicine in the field of biopharmaceutical products. It must be safe and effective as its original products, while requiring less cost and time to manufacture. Since the significant pharmaceutical patents to expire soon, many countries are introducing biosimilars in their nations as a solution to reduce the financial burden of medical expenses. In July 2009, the KFDA set up the biosimilars approval system and evaluation guidelines of international standard to meet the government's bio-industry development policy and build a support system for competitive bio-pharmaceutical products. In 2010, the administration adopted the step-wise evaluation system that allows pre-submission of required evaluation data prior to the assessment to shorten the time taken. It also provides professional consultation regarding the approval and evaluation by operating a civil consultation group.
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3) P reparing the Approval and Evaluation Standards According to Characteristics of Cell Therapy Products
Due to medical trend shifting towards customized treatment, the importance of the cell therapy products is being magnified. According to the Item Approval and Evaluation Regulation for Biological Products (KFDA notification), a cell therapy product is considered as a medicine manufactured by in vitro manipulation of the living, autologous, allogenic and xenogenic cells through physical and chemical methods such as culture and propagation. Cell therapy products are defined as autologous or allogenic or xenogenic by cell origin of the cell, or, tissue cell therapy or immunocyte therapy or stem cell therapy by cell type. By the end of 2011, cell therapy products licensed by KFDA will be 16 items, and in July 2011, the worlds first stem cell therapy product received an approval. There a total of 61 cases of approved clinical trials and 22 cases of these are tests for stem cell therapy products. Majorities of cell therapy products are expected to be released soon. The KFDA is doing its best to lead the international field of cell therapy, by improving approval and evaluation standards for cell therapy products and suggesting relevant guidelines of international standards.
04
1. Outline
Safety Management of Human Tissue
Human tissues for transplantation are part of the human body such as bones, cartilage, ligaments, tendons, skin, blood vessels, heart valves, amniotic membrane, fascia and etc., given to donated by brain-dead patients or the deceased or survivors. Unlike the organs (liver, kidney and etc.), human tissue is less likely to be rejected by the host, is available for long-term storage (3 to 5 years), and can be given to multiple patients by a single donor. However, if the donor has an infectious disease like HIV (AIDS), HepB, HepC and syphilis, it can infect patients who received the transplant. Therefore, the safety management of tissues for transplantation is very important. U.S. and Europe
3. Management of the Public-Private Communication Channel; Biopharmaceutical Industry Development Strategy Planning Group (Dynamic BIO)
Biopharmaceutical Industry Development Strategy Planning Group (Dynamic BIO) was launched in Septempber 2010. It is comprised of 5 parts (general planning, industrial support, training and public relations, international cooperation and R&D) to take the function as the control tower and maximize the effect of support given to biopharmaceutical industries. It is also making various efforts in collecting opinions and making quick decisions through public-private council for biosimilars, council for practical support of vaccine commercialization and manufactory support task force.
established the organizations and regulations to support the provision of safe tissues since the 1970s. The first human tissue transplant was done in 1972, when the Catholic University of Korea used human tissue (bone) to cure a tumor patient. Whereafter, 40 university hospitals extracted and transplanted the human tissues, such as bones, in the early 2000s. However, due to the absence of regulations and standard for tissue selection, there has been the risk of infection. The KFDA established the Advice for Safety Management of Human Tissue and Operational Guideline in February 27th, 2003, and the Human Tissue Safety and Management Act in January 20th, 2004 that was enforced from January 1st, 2005. The majority of approved national tissue banks usually extract tissues from the surgery and, less frequently, from brain-dead patient. However, domestic supplies are not enough to meet the demand. Therefore, majority of tissues are being imported
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every year. Imported tissues took up 78% of the total distributed tissues in 2010, reaches 21.5 billion won in import cost. The current condition of domestic production and import in 2010 is indicated in Table 5-4-3. Table 5-4-1 Major Uses of Human Tissues for Transplantation
Types Major Uses R econstruction of defected osseous tissue after the removal of the bone tuma Ligament reconstruction Artificial joint replacement Transplantation of skin and corium to cure the burn patient Transplantation of heart valves and blood vessel Transplantation of fascia to cure the urinary incontinence Transplantation of auditory ossicles Transplantation of demineralized bone to dental implant Cornea treatment using amnion
Table 5-4-3 Present Condition of Human Tissue Production and Imports in 2010
Class Total Total Bone

Cartilage Ligament Tendon Fascia 2,721 272 2 0 13,323 978 1,901 931 Skin 37,220 25,117 (including 703 export) Amnion 1,988 1,878 Valve 72 72
(unit : EA)
Blood vessel 326 326
258,069 200,516
143,535 (including Manufactured 173,109 1,811 export) Imported 84,960
Orthopedics
Plastic surgery Cardiothoracic surgery Urology Otolaryngology Dentist Ophthalmology
56,981 2,449 (including (including 146 re- 20 reexport) export)
12,345
970 12,103 (including (including 3 re3 reexport) export)
110
Out of the total domestic output: 173,109 - Products that processed domestic tissues: 56,665 (from tissue banks and medical facilities: 3,286, from processing company: 53,354) - Products that processed foreign tissues: 116,444 (from processing company) Out of the total amount of production and imports - Transplantable tissues processed in Korea: 66% - Transplantable tissues processed abroad: 34% - Transplantable tissues extracted and processed in Korea: 22% - Total of "Imported transplantable tissues" and "imported raw tissues processed in Korea": 78%
Table 5-4-2 Progress of Legislating the Human Tissue Act

Feb 27th, 2003 : Establishment of Recommendations and Operational Guideline for Human Tissue Safety and Management Jan 20th, 2004 : Establishment of Human Tissue Safety and Management Act Dec 30th, 2004 : A nnouncement of Enforcement Regulation for Human Tissue Safety and Management Act Dec 31st, 2004 : A nnouncement of Enforcement Rule for Human Tissue Safety and Management Act Jan 1st, 2005: Enforcement of Human Tissue Safety and Management Act Mar 23rd, 2005 : E stablishment of Operating Regulations including Approvals of Tissue Bank (KFDA notification) Mar 16th, 2010 : Revision of Human Tissue Safety and Management Act (proposed)
2. Human Tissue System Reorganization

In January 2005, Human Tissue Safety and Management Act was enacted to prevent indiscriminate imports and arbitrary transplantations, and improved the rate of domestic tissue supply through establishing the legal foundation for human tissue banks. Nevertheless, the level of dependency in import is still high, and all the imported tissues go through safety tests inspect their suitability, process history and storage methods. All of the tissue banks are required to apply the 'standard operational instructions' to secure the safety although standardized criteria have not been established. Hence, the necessity to unify and adjust management standards has been raised. Thus, the KFDA inquired the public organisations and companies as a research project, and established and distributed the standard guideline through consultations with the appraisal board for human tissue banks. It is about general safety management, including operations,
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administration, human resources management, training, document management, quality control, evaluation and selection of donors, tissue sampling, tissue processing, storage, labeling, side effect report and tissue disuse, and etc. The administration is expecting the gap of the quality and safety management to be reduced. Human tissue has low frequency of immunological rejection unlike organs such as the heart and is available to be transplanted to many patients by a single donor. Hence potential contamination by infectivity factor (viruses, bacteria, fungi) cannot be ruled out even though medical history, visual symptoms of infection, blood test and bacteriological examination on the tissues are confirmed. So the KFDA is preparing the guideline for disinfection and sterilization of human tissue and planning to improve the safety of secured human tissue. It is also planning to conduct a research on the exports manufacturers (tissue bank) through document inspections and revision of standards because document screening is not enough to secure the safety. The KFDA also conducted researches to implement NAT tests for HIV, HBV and HCV, and GTP system for human tissue banks. NAT tests can reinforce the screening inspection for tissue donors, and GTP system can provide safe tissues. Based on the result of these researches, the guideline for the GTP was established in December 2010, and in the year, inspections on foreign tissue banks are being conducted to inspect collection, processing, storage, distribution and overall quality management of imported tissues. Current Korean tissue banks still require more experience and expertise in their operation. Hence, one large-scale bank in major locations should be established for stable supply of tissues. In 2007, the research to develop a pilot project to determine the scope and structure of large-scale tissue bank was initiated. The large bank can perform extraction, examination, processing and distribution of tissue in bulk. Plans to establish the region-based large bank will proceed through the review on above mentioned research of 2007. This investigation includes analysis of Korean tissue banks, condition of domestic donation, size and distribution map of major foreign banks, and clear understanding of strengths and weaknesses of the domestic banks. Lastly, classification codes of human tissue that fits the Korean circumstances were developed (Korean registration of patent, June 2010), in order to promote the effectiveness of banks tissue management and secure the safety of transplant patients. The KFDA is also planning to develop computerised systems for integrated management of human tissues.
3. Enhancement of Follow-Up Control, Including Quality Control of Tissue Banks

The 'Human Tissue Safety and Management Act was implemented in 2005. Following that, authorizations of establishment of tissue banks were done through document screening and research on the actual condition, and tissue banks had to receive assessments to confirm quality, testing and control of tissues more than once a year. The KFDA carried out the inspections annually, based on evaluation check lists and management plans. Management in 2010 was implemented to 62 banks (37 medical institutions, 19 tissue import companies, 5 tissue processing companies and 1 not-for-profit corporation) out of 137 licensed banks by December 31, 2009. In 2011, the basic direction of tissue banks quality management is to focus on the optimization of management practices through selection and focus strategy. The considered agenda were realization of approval renewal system, quality management by specialized agencies, regular inspections that consider risks, establishment of selfassessment and foreign tissue bank inspections. A total of 59 banks (8 medical institutions, 44 import companies, 5 processing companies (4sideline), 2 non-profit corporation) are on the inspection list, including the brain dead/deceased donor banks, non-profit banks and other. It also included banks that failed quality assessments and those that did not receive the quality assessment in the last two years were. The inspection is to be conducted with experts from the private sector.
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1. C onditions and Prospects of Biopharmaceutical Products Administration 2. System Management of Biopharmaceutical Quality Assurance 3. F ostering the Biopharmaceutical Products and Building the Foundation of Support System 4. Safety Management of Human Tissue 5. Reinforcement of Safety Management Infrastructure for Medicine and Herbal Medicine 6. Establishment of Management System for Cosmetics and Sanitary Aid
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This manual also describes the raw material warehousing, storage management, final product manufacturing, and structural and management system for herbal medicine quality assurance.
05
Reinforcement of Safety Management Infrastructure for Medicine and Herbal Medicine
Once the herbal GMP system is stably implemented, national trust will be recovered through systematic quality management and the improvement in its quality.
(2) O rganization and Operation of the Development Council for Natural Pharmaceutical Industry
Korea is entering the aging society, and support of government is being demanded to secure the biotic resources and safety of herbal medicine. The general and systematic support of the KFDA were hitherto insufficient. The KFDA also formed and inaugurated a Natural Pharmaceutical Industry Development Council in March 3rd, 2011, which government related organizations, industry and academia attended. The Natural Medicine Industry Council gathers for a meeting every quarter and its department every second month. Each department is responsible for policy development and system improvement, to support the natural pharmaceutical industry. Figure 5-5-1 O rganization Structure of Natural Pharmaceutical Industry Development Council
Director General of Biopharmaceuticals and Herbal Medicines Bureau (Chair)
System Improvement Department (Herbal Medicines Policy Division) Medicine Department (Herbal Medicinal Products Division) Standard and Specification Department (Herbal Medicine Research Division)
1. Building the Safety Management System for Korean Herbal Medicine

1) Establishment of Quality and Distribution Management System
(1) P hased Introduction of GMP System to Improve the Quality of Korean Herbal Medicine
Korean medicine is traditional medicine found in Korea and is based on the use of plants and plant extracts. However, there has been national distrust due to the lack of quality standards. Furthermore, improvement of its management is being demanded due to changes of disease trends and increasing need for natural medicine by the senior citizens. To improve the quality and recover the trust of the nation, the KFDA is promoting the stable settlement system of herbal GMP in phased manner. The herbal GMP system will be implemented to new companies (new items) from the end of 2011. The transitional period will be provided for existing herbal medicine manufacturers until December 31st, 2014. The manufacturing and quality management system are expected to be organized and implemented to all Korean herbal medicine manufacturers by January 1, 2015. For the stable settlement of the GMP system, Jeonnam Herbal Industry Development Institute wrote a herbal GMO manual (proposed), which was commissioned in December 2010. The manual explains the standards established in 'Herbal Medicine Manufacturing and Quality Management Standards' and provided relevant reference data.
Total 3 Departments
Chair: Director General of Biopharmaceuticals and Herbal Medicines Bureau Departments : System Improvement Department, Medicine Department and Standard and Specification Department Department Directors : Government (Directors from Herbal Medicines Policy Division, Herbal Medicinal Products Division and Herbal Medicine Research Division) and General Director from the Private Sector Department Staff : ~20 people for each Deparment - Government : KFDA, Ministry of Health and Welfare, National Institute of Horticultural & Herbal Science - Private : Relevant Organization, Industry and Academia
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Figure 5-5-2 Inauguration of Natural Pharmaceutical Industry Development Council
be eliminated. In addition, it is not mandatory for herbal material importers to equip inspection tools, making it difficult to ensure the quality of the medicines if products are not subjected to inspections. According to the import herbal materials examination method, only 395 of 540 items are on the list. By expanding the examination list to include herbs mentioned in the Korean Pharmacopoeia and the Korean Pharmacopoeia - Herbal Medicines, the potential counterfeiting is expected to be eliminated, and safe medicine be supplied. Table 5-5-1 Number of Imported Herbal Materials on the Inspection List.
2006 2007 2008 April 2010 December 2010 All items in the Korean Pharmacopoeia and the Korean Pharmacopoeia - herbal medicine (and crude drug)
94 items 185 items 274items 395items
2) E stablishment and Revision of Korean Herbal Medicine Safety Management Standards

(1) A mendment of Management Regulations of Imported Pharmaceutical Products
Major contents of Management Regulations of Imported Pharmaceutical Products (amended on December 30th, 2010, KFDA Notification No. 2010-96) are of the following: Deleted 'musk' from the list of inspection exemption upon import to address its counterfeit products being distributed in the market, expanded the range of herbal medicines subject to detailed inspection (395 items) to all items listed in both The Korean Pharmacopoeia and The Korean Pharmacopoeia - Herbal Medicine Codex to prevent the distribution of illicit medicines (Note: Herbal medicine includes both Korean herbal medicine and crude drugs). 'Musk' is a high priced herbal material that has concerns to be counterfeited and requires a strict distribution management plan. However, its inspection can be exempted if imported by the pharmaceuticals or Korean herbal medicine manufacturers, providing opportunities for counterfeited product to be distributed in the market. However, other high priced herbal materials such as deer antlers and ox bezoar and aloeswood are on the exemption list, which means that they must be tested at import stage, and is managed accordingly. Therefore, by adding Musk to the inspection-exemption-not-allowed list, the potential counterfeiting can be expected to
(2) R evision of Standards and Test Methods for Residues and Pollutants in Herbal Medicines
Major contents of Standards and Test Methods for Residues and Pollutants in Herbal Medicines (amended on October 29th, 2010, KFDA notification No. 2010-75) are as follows: established the new pesticide residue limits for 10 items including licorice and included 43 items, such as oryzae fructus germiniatus, to sulphur dioxide residue tests. For pesticides that were newly registered in the guideline for safe use of pesticides to be used on herbs, uncontrolled use can occur if they do not have residue limits prepared in the Standards and Test Methods for Residues and Pollutants in Herbal Medicines. Hence, it was necessary to establish residue limits for each herb. This was also to promote the competitiveness of the industry through assurance of safety and enhancement of product quality. The testing standards of residual sulfur dioxide were needed to be established for the items, other than 265 items with the existing limit standards. 43 more items were selected through analysis and monitoring of residual sulfur dioxide with the expert advisory committee and general deliberation committee. Therefore, safety was secured through the rearrangement of residual sulfur dioxide that could be introduced during the processing of herbal medicines (briquet dry and sulphur fumigation).
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(3) E nactment of Regulations for Item Approval and Reporting of Herbal Medicine
Regulations for Item Approval and Reporting of Herbal Medicine was notified on May 30th, 2011 after its amendment proposals in December 10th, 2010. It combines relevant sections on herbal medicines from both Item Approval, Declaration and Evaluation Regulation for Pharmaceuticals and List Declaration Regulation for Herbal Medicines with Specifications. It is simplified and clarified the approval, declaration and evaluation regulations of natural pharmaceutical products to enhance the publics understanding and improve related regulatory processes. Main contents include the range of registration objectives, approval procedures (and reporting), safety, effectiveness, standards, screening method and registration of standardized herbal medicines. This enhanced the convenience of registration and reinforced the competitiveness of domestic companies. The KFDA is also collecting various opinions to develop an improvement plan for the registration procedures, regulation and rules revisions to support the development of herbal medicines. With various opinions and suggestion, regulations and policies will be consistently revised in order to improve the characteristics of herbal medicine.
trial program was 45 in 2009 and increased ~33% a year. There were 176 civil inquiries made in regards to clinical trials approval, displaying 24% increase compared to 2009. This reflects the industrys attention on the development of new natural medicine (Figure 5-5-3). Figure 5-5-3 N umber of Clinical Trial Approvals and Relevant Civil Inquiry of Natural Pharmaceutical Products
Cases 180 160 140 120 100 80 60 40 20 0 2005 2006 2007 2008 2009
Inquiries
clinical trials
2010
Clinical Trial Approvals and Enquiries Received
2. Approval and Evaluation of Herbal Medicines

1) Outline
(1) T ransition of Civil Service for Herbal Medicine
Due to the increase in chronic diseases based on life style changes and the aging society, the alternative medicine market is growing. Also, due to the integration of western medicine and herbal medicine, and the increase in demand for herbal medicine, the role of herbal medicines and crude drugs are becoming significant. Recently, pharmaceutical industries realized the merit of herbal medicines and began putting spurs to develop new natural medicines. This can be confirmed by checking the number of approvals requested for clinical trials and civil inquiries. The number of clinical trials has been steadily increasing since 2004 and in 2010, and the KFDA received 60 clinical trial approval requests. The number of permitted clinical
2) Major Achievement in 2010

(1) Current Status on Approved Products
Approved herbal medicine of 2011were 12 items, which was same as the previous year. However, the number of the domestically produced items were decreased to 5 from 11 items whereas the number of imported items increased to 7 from 1 item. (Table 5-5-2) In 2010, 7 items were prescription drugs, which took up 60%, and included 2 orphan drugs. The orphan drugs, which use absorbable collagen Hemostats, are the main ingredients in hemostatic agent (Table 5-5-3).
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Table 5-5-2 List of Permitted Herbal Medicines

Type Herbal medicines Total 12 Number of Approved Items Manufactured 5 Imported 7 Note 1 Korean herbal medicine (1 manufactured)
based on the prescription, Banhasasimtang succus. Banhasasimtang succus is based on the prescription of Banhasasimtang of Donguibogami. It was only permitted as powder and granule until now, but now liquid forms are approved for the first time. Table 5-5-3 List of Approved Herbal Medicine in 2010
Nu -mb -er 1 Type Company Product Name Ingredient Approved Effect Note
Figure 5-5-4 Current Condition of Herbal Medicine Arranged by Effects

Medicines for Sensory Organ 8% Metabolic Medicines 25%
Yuhan Newfactan produced Yanghaeng 240mg Co. Ltd.
Cow lung extract
Dec 12 Infant respiratory prescription 2010 distress syndrome Blood circulation disorder (arteriosclerosis)
The number of items
2
Medicines for Organ System 67%
Garlic oil/Crataegus Dong-A Oxyacantha 60% Jan 18 Pharmaceutical Circuran Ethanol ext./Melissa produced 2010 manufacturer Tab. leaf ext./Ginkgo flavon Co. Ltd. ext. Steleophaga plancyi Boleny/Aconitum ciliare Decaisne/Nux Vomica/Rhubarb/ Dalbergia odorifera/ Zanthoxylum piperitum De Candolle/Scutellaria Hwata baicalensis / World one analgesic Imported Phellodendron trade ointment amurense/Reynoutria japonica/synthesized Dryobalanops aromatica GAERTNER/ Peppermint oil/ dl-kampa/Methyl Salicylate/L-menthol produced Dong Wha Pharm. Co., Ltd Enter Pharm Co., Ltd. Enter Pharm Co., Ltd. Viofive granule Nova cole Fibrilar Nova cole Pad Psyllium powder/ Alexandrian Senna fruit powder/nicotinic acid amide/lactomin Absorbable collagen Hemostats Absorbable collagen Hemostats
Nonprescription
Figure 5-5-5 Current Condition of Herbal Medicine Arranged by Dosage Forms

3
Injections 8% Cataplasma 8% Drops 8% Granules 9%
201002-02
Anti-inflammatory Nonanalgesic prescription
The number of items
Tablets 50%
Liquids 17%
Feb 25 2010 Apr 6 2010 Apr 6 2010
Constipation and symptoms Hemostasis assistance for surgery Hemostasis assistance for surgery Diet adjurvants for secondary prevention and decreasing triglycerides
Nonprescription Prescription, Orphan Prescription, Orphan
Imported
In terms of medical effects, there were 8 medicines for organ system, taking up 67%, metabolic medicines had 3 items taking up 25%, and medicine for sensory organ had 1 item taking up 8%. When arranged by form, there were 6 items in tablet taking up 50%, 2 liquids items taking up 17% and 1 item for each of injection and drops. Most of the approved items were crude drugs, and there is 1 produced item approved
7 6 Import
Kwang dong Oster Soft produced Pharmaceutical capsule Co., Ltd.
Omega-3 acids ethyl ester 90
May 7 2010
Prescription
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Nu -mb -er
Type
Company
Product Name
the quick modification of approval regulations that fit rapidly growing medical and
Ingredient Approved Effect Note
pharmaceutical industries. Lastly, the KFDA prepared a task force team to carry out all the mentioned achievements in consumer and industry-focused manner.
Imported
Yuyu Umckamin Pelargonium sidoides Sep 17 Pharma, solution ext. 2010 Inc. Ripidem Inj. Middle chain triglycerides/Refined soybean oil/Omega-3 acids triglycerides
Acute, chronic Prescription infectious disease
B. Braun Imported Korea Co., Ltd.
Sep 17 Supply of essential Prescription 2010 omega 6 fatty acid
(3) R evised Approval Regulations to Facilitate the Development of Various Dosage Forms
The activity of herbal medicine industry was decreased after drug prescribing and dispensing became separated. To recover its past vitality, experts noted that traditional medicines need to be combined with modern pharmaceutical technology, moving on from their usual dosage form of tablets or powders. The KFDA amended burdensome regulations for screening data submission (grade
10
Han Wha Imported PHARM Co., Ltd
Iberis amara 50% ethanol tinc./Angelica root 30% ethanol tinc./Matricaria flower 30% ethanol tinc./ Caraway fuit 30% ethanol tinc./Milk Iberogast Thistle 30% ethanol Nov 12 2010 tinc./Chestnet leaf solution ethanol tinc. 30%/ Peppermint leaf 30% ethanol tinc./ Chelidonium majus Linne 30% ethanol tinc./licorice 30% ethanol tinc. pinellia/scutellaria baicalensis/ginseng/ licorice/jujube/ dried ginger/Coptis Chinensis FRANCH root liquid paraffin/light liquid paraffin
Gastrointestinal disorders
Prescription
of clinical difference test, biological parity test and etc.), which can create barriers, to offer more reasonable data scope for the relevant industries. Also, basic regulations were established to prepare for future amendments in approval regulations by forming an expert council with the pharmaceutical industry experts and the KFDA officers.
11
Iksubanh Iksu asasim produced Pharmaceutical -tang Co., Ltd. solution Bausch & Lomb South Asia Inc.
Dec 23 2010
Acute, chronic camouflage catarrh
Nonprescription
(4) L egislation of Clinical and Non-Clinical Guidelines of Herbal Medicine

We prepared the following guidelines for the objectivity and transparency of safety, effectiveness and quality (standard and test method) evaluation of herbal medicines. Published guidelines are as follows: Guideline for Clinical Trials of Herbal Medicine - Chronic Lower Back Pain Guideline for Efficacy Testing of Herbal Medicine - Atopic Dermatitis Guideline for Efficacy Testing of Herbal Medicine - Allergic Rhintis Guideline for Efficacy Testing of Herbal Medicine - Systemic Lupus Erythematosus Guideline for setting up Chemical Ingredient Profiling of Herbal Medicine Guideline for Clinical Trials of Herbal Medicine Herbal medicine is attracting the public attention as the alternative solution to eliminate the concerns about the long-term use of chemotherapeutic agents used to treat chronic lower back pain. It has become a diseases preferred to be treated using natural methods at the Symposium of Herbal Medicine Clinical Trial in 2006. This
12
Imported
Soothe XP eye drop
Dec 24 2010
Palliation of burning sensation caused by dry eye
Nonprescription
(2) E stablishment of Separated Approval Regulation for Herbal Medicine

Herbal medicines have properties that are not prescriptible unlike chemical medicine. The approval regulation was hitherto a part of general medicine regulations and caused the public difficulties in understanding them. Therefore, the KFDA separated and enacted the herbal medicine section from the general medicine regulations to promote the development of natural medicine. The independent foundation for the quality and safety management for herbal medicine was established. The flexibility of the regulation was secured through
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guideline describes the Herbal Medicine Diagonostic Standards of Lower Back Pain and Criteria to Assess Effectiveness of Herbal Medicine. This guideline was introduced and distributed through presentations, press release and homepage. This is the first guideline handling the herbal clinical trial of chronic lower back pain scientifically and reasonably, marking its significance. The administration will continue to develop the guideline by documenting further researches on safety and efficacy of herbal medicines. Guideline for Clinical Trials of Herbal Medicine
Guideline for setting up Chemical Ingredient Profiling of Herbal Medicine It is generally difficult to identify all the chemical structures and properties of herbal medicines produced from natural materials because it contains a wide range of compounds. Although some of active ingredients and correlation between the ingredients and affects were identified, it is not always possible to identify such correlations. So far, the method that manages the active component has been used only if the active component is revealed and possible to be standardized. If the active component is not yet to be identified or its analytic sensitivity and accuracy cannot be assured, a standard for a representative substance with similar property was used. Nonetheless, majority of cases are not even possible to set a representative index. Therefore, the key point of herbal medicine quality management is to control the uniform proportion of the compounds. Chemical profile is a comprehensive and consistent information of chemical properties of herbal medicines. Its purpose is to secure optimum quality and homogeneity of effects and quality by identifying and managing the valuable properties to assure safety and effectiveness of the medicine. This guideline contains the appropriate examples along with the object, scale, assurance and verification method of the Chemical profile. It also suggested the
Efficacy tests for medicines include data to confirm their safety and efficacy. The data required for the submission must prove pharmacological mechanisms of the effect expression. In case of herbal medicines, it is not easy to establish experimental models suitable for such purpose and evaluate the results accordingly. The guidelines for 'atopic dermatitis', 'allergic coryza' and 'systemic lupus erythematosus provide recommendations to researchers in terms of test methods and examples, with the consideration of herbal medicinal properties, to bring out objective and fair results. The KFDA collected opinions and suggestions of the public and industry to publish the guidelines. It was also provided to the public through presentations, press release and homepage upload.
methodology that assures the quality of confirmed effects and the equability of the manufacture's serial number. This guideline was introduced and distributed through the presentations, press release and homepage. Other Activities On November 11th, 2010, the KFDA hosted a presentation on Approval and Evaluation Policy of New Natural Pharmaceutical Products at Grand Hilton Hotel Korea to support the commercialization of new natural medicine and strengthen its global competitiveness. At the presentation, submission range and time of nonclinical trial materials were accounted for the approval of a clinical trial program. Also, explained was the evaluation method that secures the quality parity, and the
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results of standardization of herbal medicine(research conducted by the KFDA) were introduced. The presentation was attended by ~300 persons and was considered as an event that supported the nature-based pharmaceutical industry.
Improvement of Processing Capability for Approval and Evaluation of Natural Medicine To improve the processing of civil inquiries, the KFDA is planning to standardize approval and evaluation regulations to resolve the confusion in the civil service, and reduce the recurrent demands for the supplementation by activating the two-way communication. The KFDA will organise a practical research group for natural medicine. It will expand the education and training to improve the evaluators capacity and expertise, and specify the role sharing and cooperation procedures in natural medicine approvals. Also, the Approval Adjustment Council for Natural Medicine will be formed to revise and strengthen current standards in approval and evaluation. Also, the civil service consultation history managing system will be established and question and answer on natural medicine will be published to enhance the two-way communication with the public.
3) 2011 Plans and Prospects

Supporting Natural Medicine Development and Reinforcing Competitiveness Recently, interests in the natural medicine development are rising with natural medicine sector being selected as one of the leading technologies of future industry. However, constituents of the natural medicines are complicated. Hence, establishing quality management of raw materials to complete products, and developing safety and effectiveness evaluation standard, have been considered as a key to secure their competitiveness. In addition, to resolve the recession of traditional herbal medicine market and recover the trust of the public, it is essential to adopt the rational and scientific regulations to activate the development of herbal medicines in various dosage forms. The KFDA is planning to operate Joint Expert Council with Public-Private Sector that is composed of the pharmaceutical industry experts and persons in charge in order to amended the approval regulation to specifies the definition, scope and evaluation requirements of natural medicine adopt the quality management standard based on chemical profiles that reflect comprehensive properties of various constituents of natural medicines and prepare internal quality management standards for herbal medicine companies, based on the traditional herbal medicine books. Also, below guidelines providing customized information on quality, non-clinical trial and clinical trial of natural medicine development is to be published. Information on Ingredients and Extraction of Previously Approved Medicine Standards and Major Formats in writing Manufacturing Methods per Ingredients Guideline for Non-Clinical Trial Data in Natural Pharmaceutical Development and Approval
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upon the human body. Quasi-drugs have less concerns on misuse or abuse, and are expected to keep their safety and effectiveness intact without prescriptions are written out by doctors or dentists. It includes about 30 items such as sanitary pads.
06
Establishment of Management System for Cosmetics and Sanitary Aid
Actual output of quasi-drug is 1.1 trillion won, showing 12% growth compared to the previous year. Figure 5-6-1 Production Output of Domestic Cosmetics Industry
6,000 (Unit : billion won)
1. Current Conditions and Prospects of Cosmetics and Quasidrugs

1) Industrial Trends in Cosmetics and Quasi-drugs
Cosmetics is a product used to clean and beautify human body, by enhancing attractiveness or by maintaining the health of skin and hair. Due to changes in living standards and increasing interests in beauty, demand for cosmetics is also rising. The size of the Korean cosmetic market has grown by approximately 11 trillion won, taking up 2.0%(the 13rd) in the worlds cosmetic market in 2009. The actual output of the domestic cosmetic product is roughly 5.1 trillion won, showing a 9.5% increase when compared to the previous year. Under the influence of Korean popular culture, exports have sharply risen in 2010 providing 590 million dollars, and it is showing continuous growth. Due to the aging society and well-being trend, the cosmetic industry became a new growth engine from the luxury industry, reflecting its value and importance. Along with this trend, demand of natural, organic, herbal, environmentally friendly and ethical cosmetic products are increasing. It is also able to use it for leading businesses of lowcarbon green growth as one of the higher value-added brand businesses, showing the great possibility in further growth. The term Quasi-drug in the Korean pharmaceutical affairs law refers to fiber, rubber products or similar items, which are used for the purposes of treatment, reduction, disposal or prevention of human or animal diseases. It also includes nonappliance, non-machinery or similar articles, which act slightly upon or do not act
5,169
5,000 4,000
3,436 3,980 4,073
4,720
3,692
3,000 2,000 2004 2005 2006 2007 2008 2009
Source: Korea Cosmetic Association
Figure 5-6-2 Actual Import and Export Record of Cosmetics

900,000 800,000 600,000 400,000 200,000 0 -200,000 -400,000 -600,000 2004 2005
-287,692 -324,431 -405,016 -447,756 -482,173 538,887 251,195 589,076 264,645 751,823 685,327 280,311 304,067 363,823
(Unit : 1,000US $)
845,996
833,947 Import 423,240 Export
-410,707 Trade Deficit
2006
2007
2008
2009
Source: Korea Customs Service
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2) C urrent Condition and Prospect in Safety Management of Cosmetics and Quasi-drugs

The publics interest in the safe use of cosmetics and quasi drugs have been increasing from incidents of detecting formaldehyde and dioxane in the baby bath cosmetics and asbestos in baby powder. Therefore, there is a need to inform the public of relevant information through monitoring of risk information from domestic and foreign channels and establish advanced standard for international competitiveness of the industry. With Kor-U.S. and Kor-EU Free Trade Agreement, Chinas market expansion, lowered customs duty and import procedure simplification, Korea is currently facing a global competitive environment. It also means there is a risk in importing defective products and cross-certification opportunities.
3) Establishment of Safety Standard for Cosmetics Containing Hwangtoh (Red Clay)

The lead ( powder product 50ppm about the product which in order to resolve the safety assurance about the yellow soil containing cosmetics and consumer distrust, it informs the cosmetics standard and testing method the revision and uses the clay Due to the issue on some of the Hwangtoh facial packs containing heavy metals, the KFDA amended the Standard and Test Method for Cosmetic to set lead (50 ppm for powder, 20 ppm for other types) and arsenic (10ppm) standards.
4) Improvement of Information to Promote Safe Use of Cosmetics

After the implementation of all ingredients indication system for cosmetics, the KFDA prepared the legal basis for labelling safety information per ingredients(amendment of Enforcement Regulation for Cosmetics Act, March 12th,
2. Establishment of Foundations for Safe and Appropriate Use of Cosmetics and Quasi-drugs
1) C omparison and Review of Domestic and Foreign Hazardous Substance Management Policy
The KFDA reviewed and amended 1,651 policies for Cosmetics and 223 policies for Quasi-drugs through the project to advance standards and specification (July 31st, 2009).
2010). The amendment stipulated the cosmetic products to label 12 substances, including formaldehyde, to raise the awareness of consumers in hazards associated with cosmetic products.
3. Improvement of Industrial Competitiveness by Managing Safety in Production

1) Establishment of Acceptable Standards for Detection of Adventitious Hazardous Substances
Past incidents where formaldehyde and dioxane were detected in childrens products, and dibutyl phthalate in the nail enamel, created the public concerns. Formaldehyde, dioxane and dibutyl phthalate, are prohibited substances that cannot be used in cosmetics. The review revealed that these were created as by-products from cosmetic manufacturing procedures rather than being added on purpose. Thus, the KFDA conducted the review of the safety management standard to establish standards for adventitious hazardous substances, such as formaldehyde,
2) O bligation of Childrens Toothpaste to Display a Guide for Safe Use

If a child swallowed or ate the toothpaste that contain fluorine, it may cause fluorosis. The KFDA revised the system to make it mandatory for childrens toothpaste to indicate the guide for the safe use to prevent adverse effects, such as above mentioned.
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p-formaldehyde and phthalate, to resolve the publics concern and support the industry.
4. Reinforcement of Safety Management for Distributed Cosmetics and Quasi-drugs

1) Establishment of the Guideline for Management Standard of NanoCosmetics
The purpose of this guideline is to define nano-cosmetics and suggest the management standard for labelling and advertisement, in order to secure the safety of the product, protect national health, and promote R&D of nano-cosmetics. This guideline specifies the size of nano materials, and definitions of nano substance and nano-cosmetics. It also requires manufacturers to prepare data to support that the product has nano-property upon labelling and advertising it as nano-cosmetics. Lastly, if the product is infusible or body durable, it stipulates the manufacturer to prepare safety data.
2) Establishment of Application Standard for Carbon Black

Carbon Black (D&C Black No.2) is the coloring substance for cosmetics. It is a preferred substance for mascara and eyeliner because of its great impression of the color. However, it has been treated as a prohibited substance because of the impurities, including benzopyrene and dibenzanthracene. U.S. and EU control the amount of Carbon Blacks impurities for its use in cosmetics, raising the concern of the domestic industries in terms of competitiveness. Therefore, the KFDA revised the safety standard for impurities, so Carbon Black can be used as the cosmetics coloring and established the guideline on testing methods and standards, to secure the safety of consumer, and quality and competitiveness of the cosmetic products.
2) Cosmetics and Quasi-drugs Surveillance 3) E stablishment of Guideline for Cosmetic Indication and Advertisement
After the recent coverage of the cosmetics that contained illegal steroids, dissatisfactions and doubts have been amplified due to the absence of regulations, confirmation object and method, labelling and advertisement. The KFDA established and implemented the guideline for indication and advertisement by receiving opinions from industries and organizations. This guideline is expected not just to secure consumers trust, but also to lay the foundation to improve the domestic cosmetic industrys international competitiveness. To build a basis of safe production and distribution management for cosmetics and quasi-drugs, the KFDA annually establishes the Basic Plan for Production and Distribution Management to set the general direction of product surveillance and conduct post-managment. The general direction of surveillance for 2010 was to strengthen autonomous review of policy application and management by relevant industries. It also implemented the focused surveillance on unreported and companies that did not meet the given standard. If the company produced improvement methods through self-assessment, the KFDA gave exemptions in enforcing administrative measures. It aims for the efficient post-management through the joint surveillance with KFDA head quarter, regional KFDA and local governments. In the field of cosmetics, focused inspections included surveillance of prohibited and controlled substances and sellers misconduct. The products that received this surveillance were products for children, color make-ups, and nail and toenails. In the field of quasi-drugs, the KFDA improved the inspections on manufacturing and recall/discard processes. For companies subjected to GMP, the KFDA confirmed
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their progress in product validation, which began from 2010, and provided trainings for companies that did not meet the standard. Table 5-6-1 Surveillance Results for Cosmetics and Quasi-drug Manufacturers and Importers (2010)
Infringement Details Type Cosmetics Quasi-drugs Company 566 294 Subtotal 385 231 Quality Inadequate Labelling and Standard management equipment Advertisement document 57 36 10 4 241 87 11 10 Other 66 94
(Unit : EA)
4) Collection and Inspection of Cosmetics and Quasi-drugs

Every year, the KFDA established the general plan for quality inspection to improve the quality management of cosmetics and quasi-drugs. The work is shared by regional KFDA and local government by them taking the responsibility of product recalls and on-site inspections. Quality inspections of distributed products were redeployed to the local government in July, 2009, according to maintenance plans of specialized local administrations. Therefore, regional KFDA began to conduct the quality inspections of apprehensive items, and local government enforcing the quality examination based on the customized detail plans. Cosmetics and quasi-drugs are readily available to the public and are used in high frequency. The quality management system will be strengthen to prevent the distribution of defective cosmetics and quasi-drugs. It is planned to collect and examine items of high demand/interest and items such as childrens, toothpaste, hair dye, sanitary pads and functional cosmetics are to be inspected vigorously to ensure the safety of the public in using these products.
3) Inspection on Advertisements and Labeling

Cosmetics and quasi-drugs are products that the majority of people use on a daily basis. It can be sold without restrictions because the range of seller has expanded and purchase patterns changed by the propagation of internet media. Hence, issues with exaggerative labelling and advertisements have been concerning the public. Most companies who infringe regulations often are not aware that there are existing regulations. The KFDA often advise them to correct the error, and only charge them with of crime when they intentionally infringe the rule. Although it has not been very effective thus far. The solution to eradicate exaggerated labelling and advertisements are in demand. Currently Cosmetics Act is undergoing reviews to adopt a new advertisement system, which stipulates the cosmetic companies to substantiate the proposed effect of cosmetics through the provision of supporting data. The revision to determine effective punishments are also being considered, but in terms of prevention, observation and monitoring duties should be focused. The KFDA reviewed exaggerative labels and advertisement, which may mislead consumers in believing that products have pharmaceutical effects or deceive them by indicating organic or natural material content. It also inspected cosmetics for children with atopic conditions. All of the review was dictated by the prepared Guideline for Organic Cosmetics Labellig and Advertising, which was implemented from 2010. For quasi-drugs, the KFDA inspected the labelling for yellow dust or swine flu proof for the normal masks and instructions for use in childrens tooth paste.
5) Detection of Steroids from Cosmetics

Based on a report describing steroid detection from certain cosmetics, the KFDA conducted inspections of suspected items. The result revealed that clobetasol propionate, a steroid, was detected 3 products (14~41 ppm). The KFDA inspected relevant companies and collected the articles for examination. The administration also collected products with suspected inclusion of steroids by monitoring internet shopping malls or receiving civil complaints, and subsequently discovered that steroid substances - triamcinolone, Prednisone acetate and Betamethasone Valerate, in these products. A steroid hormone, also known as adrenocortical hormones, is an essential life conserving substance, maintaining the homeostasis. Due to its properties, many kinds of similar synthetic materials were developed as the medicine possessing pharmaceutical effects, such as anti-inflammatory effects, being called a steroid as whole. Although it is very effective and useful, indiscriminating use can cause serious adverse effects. Therefore, Glucocorticoid and Antiandrogens with steroid structures
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were prohibited from being used in cosmetics. The KFDA prepared steroid detection methods and reference standard for cosmetic products, and distributed them to regional KFDAs, Institute of Health Environment of each city and province, organization to initiate relevant tests. The administration also collected suspicious items and conducted nation-wide inspections. Based on a report of products containing steroid distributed by a medical institution, the KFDA collected and inspected 50 products from 45 places, including hospitals and cosmetic shops. The inspection showed that steroid substances were found in 14 items out of 187 that were examined. The administration continues to conduct collection and inspections of cosmetic products (Table 5-6-2). Table 5-6-2 List of Cosmetics that Contained Steroids
No. 1 2 3 4 5 Company Di-Ves, Co. Di-Ves, Co. Di-Ves, Co. Jang's Cosmetics Withyou Herbal Biotechnology Institute Product Pine Topy Moisturizer & Soothing Cream Pine Topy Moisturizer & Soothing Cream Pine Topy Moisturizer & Soothing Cream Damil Multi herbal Cream Doduwon Composite Herbal Cream Serial number (Packing date) 100729A (2010.7.30) 100809A (2010.8.9) 100210 (2010.2.10) DH100702 (2010.7.17) Name of the Steriod Clobetasol Propionate Clobetasol Propionate Clobetasol Propionate Clobetasol Propionate Clobetasol Propionate Triamcinolone aceto nid (2010.7.29)21Prednisone Acetate Triamcinolone acetonid (2010.6.28.)21Prednisone Acetate Triamcinolone aceto nid Content (g/g) 49 41 14 23 4 23 21 45 95 40 67 17-Betamethasone Valerate F011 (2010.6.12) 21-17Betamethasone Valerate 1,064
No.
Company Peauciel Cosmetic Co., Ltd. Dong Sung Pharm Co., Ltd
Product
Serial number (Packing date) DD85JF01
Name of the Steriod Triamcinolone Acetonide (2010.6.17)21Prednisone Acetate (2008.12.15) Triamcinolone Acetonide Triamcinolone Acetonide (2010.2.2)21Prednisone Acetate 17-Betamethasone Valerate 17-Betamethasone Valerate
Content (g/g) 43 37 14 11 21 1,045
10
Skin Top
11
AC HAHA Cream
DC10HL01
12
I-Natural Cosmetic
A16 Cream Aurore Whitening Solution(SnowII) Aurore Clearing Solution(Ice II)
C02009 20100820 (20100820) 20100820 (20100820)
13 14
BMC Ivy Co., Ltd. BMC Ivy Co., Ltd.
submarginal
5. Increase in Transparency and Predictability of Evaluation

1) Rapid Evaluation of Functional Cosmetics
As the cosmetics effects are expanding from simple correction of skin color or beauty treatment to creating beauty and activating the function of skin, development of functional cosmetics is becoming more popular. Thus, the number of functional cosmetics that were reported to KFDA is gradually increasing, especially, in multifunctional cosmetics.
Happy Cosmetic
Glaube Cream
AG2306
Peauciel Cosmetic Co., Ltd.
Noa-K1
DD76JI02
Dong Sung Pharm Co., Ltd
Atohhaha Cream
DC08JF01
Cleans Cosmetics
Limpia Whitening Cream
15
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Figure 5-6-3 Current Condition of Annual Evaluation (Including Reported Items) for Functional Cosmetics
Number of items 2,000 1,500 1,000 500 0 2005 2006 2007 2008 2009
The report system will be expanded to products with secured safety and efficacy. The KFDA is going through necessary processes in preparation, by selecting suitable items. It is expected that the administration will focus on cosmetics with dual-functions.
Combination Wrinkle Improvements UV Block Whitening
2) Establishment of Foundation for Enhanced Quality Assurance and Realiability of Cosmetics and Quasi-drugs
Approval and evaluation policies for cosmetics and quasi-drugs were improved, and regulations/guideline for the safety, efficacy and quality assurance of these products were amended. Major content includes the suggestion of Guidelines of Analysis of Hazardous Substances in Cosmetics, allowing the quality management of adventitious toxic substances by the industry. Also, multiple guidelines, such as the use standard for carbon black and testing method for the active substance in hair tonic, were
It is difficult to manage evaluation of functional cosmetics with limited human resources. Hence, the KFDA revised the evaluation system to enable the electronic document system for the reporting of those functional cosmetics with both previous item approvals, and assured safety and efficacy. This system decreased direct evaluations of products although the items listed as functional cosmetics are increasing. This allowed the KFDA to focus on the evaluation of substances that need professional reviews or items with specified administration or forms. Figure 5-6-4 Evaluation/Reporting Status per Year
Number of items 7,000 6,000 5,000 4,000 3,000 2,000 1,000 0 2008 2009
Evaluated items Reported items
established to invigorate cosmetics and quasi-drug industry. Table 5-6-3 Achievements in Improving the Reliability of Cosmetic and Quasidrugs
Achievements Details Review of assessment results for the safety of toxic substances such as Assuring Safety and formaldehyde Managing Adventitious Revision of regulation on designation of cosmetics raw material Hazardous Substances Revision of guideline for analysis of cosmetic formula in Cosmetics Revision of guideline for analysis of toxic substances in cosmetics Improvement of Cosmetic Colouring Standards Usage standard of Carbon Black Establishment of guideline for Carbon Black testing method Proposal and Notification for tar colour types, standards and test methods used in cosmetics
Preparing guideline to select test items in forming quasi-drug test Preparing Guideline for methods and standards Quasi-drugs Preparing the guideline for hair tonics active substance measurement Preparing the guideline for the specification of quasi-drug additives Preparing the Guideline Preparing the manual for cosmetic standard testing methods for Securing the Safety Preparing the guideline for repeated dose toxicity test method of cosmetic and Quality of Cosmetics
2010
Operating consultation group for specifications of cosmetic raw materials Operating Consultation Operating consultation group for SPF (sun protection factor) measurement Group for Cosmetic and standard Quasi-drug Standards Operating consultation group to prepare for quasi-drug standards and specifications
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3) Enhancement of Approval and Evaluation for Quasi-drugs

Guidelines to select test items in quasi-drug was published, to suggest test items of quasi-drugs by item types, for effective quality management. The products that have the properties of hair loss prevention and hair growth usually consist of many types of active ingredients. Since it is difficult to conduct tests on these substances, the KFDA standardized the examination method to establish guideline for hair tonics active substance measurement
Figure 5-6-6 Various Effects of Quasi-drugs
4) P ublication of Promotional Material for Safe Use of Cosmetic and Sanitary Aid
The KFDA published a leaflet on Various effects of quasi-drugs to promote safe use of quasi-drugs. Also to secure childrens safety, notice on childrens cosmetics and childrens toothpaste choice and oral health care were distributed to the schools. Figure 5-6-5 Promotion Material for the Use of Childrens Cosmetics
6. Reinforcement of International Cooperation for Cosmetics

1) Cosmetic-Related Exchange between Korea and China
China is the number one (42%) importing country and the ninth exporting country of Korean cosmetics. It makes China a very important cosmetic trade partner, and the trade volume is annually increasing. Therefore, the KFDA finalized the cooperation agreement on the cosmetic field with Chinese SFDA (State Food and Drug Administration), and held the first cosmetic practice conference in Seoul during 2010 for mutual understanding and information exchange of cosmetic systems and regulations of two countries. The second practice conference was held in Shanghai on May, 2011 and was agreed to established a direct communication channel for cosmetics, exchange cosmetic information, and discuss relevant regulations and standards through public-private joint conferences of experts. It offered a valuable opportunity to hear issues and understand the different regulations. The cooperative contract of cosmetics was finalized with the Chinese quarantine department in 2010, to discuss the mutual information exchange and cooperation method.
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2) International Cosmetic Safety Workshop

The International Cosmetic Safety Workshop began in 2004, inviting officers in charge of cosmetics from the major importing countries, to exchange information on standards, approvals, safety and trade, contributing to mutual understanding. In 2010, officers in charge of cosmetics from Mongolia and Malaysia attended. Through this workshop, we introduced Korean cosmetics management system, and discussed the method of mutual cooperation. Figure 5-6-7 2010 International Cosmetic Safety Workshop
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Chapter 06
Medical Device Area

01 The Condition and Direction of Medical Devices Safety Control 02 Improvement of Medical Devices Pre-Management System 03 International and Scientific Approaches to Medical Device Standards and Specification 04 Establishment of Medical Devices Quality Management System 05 Strengthened Post-Management of Medical Devices
1. The Condition and Direction of Medical Devices Safety Control 2. Improvement of Medical Devices Pre-Management System 3. International and Scientific Approaches to Medical Device Standards and Specification 4. Establishment of Medical Devices Quality Management System 5. Strengthened Post-Management of Medical Devices
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digitalization, networking and the introduction of U-healthcare for electro-medical devices based on technological advances in IT, BT and nanotechnology (NT). In tune with advances in medical devices development technologies, Global Harmoniztion Task Force (GHTF) was established, with US and Europe playing a leading role. This was to minimize the differences in approval systems and standardize management systems between countries. GHTF has achieved many results since its establishment and continues to organize active discussions between involved countries.
01
values.
The Condition and Direction of Medical Devices Safety Control
1. Policy Environment
The importance of medical devices is in both domestic and foreign settings, being recognized as a new growth engine and a key industry in the enhancement of public health. Furthermore, the introduction of medical devices that converges information technology (IT) and bio technology (BT) is identified as an industry with high investment Korean government selected medical devices as a new growth engine, owing to the remarkable development of IT industry, and subsequently established focused development foundation. It is currently expanding its newly developed medical device market with technology convergence to the field of hospital informatization, and home & mobile and ubiquitous healthcare (U-healthcare). Based on the expansion of medical devices market and increase in product demand, consumer-focused post-management, provision of safety information, and preparation of an environment that allows sale or use of safe medical devices by the public are being highlighted as well as the governments support in promoting the growth of its industry.
1) Characteristics of the Medical Devices Industry

The medical devices industry brings highly advanced knowledge and technologies together to produce and distribute products that contribute to the enhancement of health technologies and health services. It also includes industries that manufacture and distribute relevant products, such as machines, equipments, medical supplies and dental products. Although it may lag when compared to other industries such as machinery or electronics, it is assessed as one of the major industry with high investment values with potentials for future growth.
2) Current Status of the Global Medical Devices Industry

In 2010, American region was the biggest market for medical devices, taking up 45.1% of the world market size. Next was by Western European region, which includes countries such as Germany and UK, taking 29.8%. Asia-Pacific region, including China, Japan and Korea, took up 18.1%. When these three regions are combined, they cover 93% of the global market size, which shows that they are the dominating regions in the global market.
2. The Actual Condition and Prospect of Medical Devices Industry

The market size of medical devices is expected to expand based on changes in society trends, for example, ageing and well-being. This is accelerated further by
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Table 6-1-1 World Medical Devices Market Size According to Geographical Locations (2010~2014)
2010 America Asia/ Pacific Asia/ Pacific Middle East/ Africa Western Europe Total 106,507 42,850 11,175 5,261 70,428 236,221 2011 110,753 46,619 12,279 5,692 74,176 249,519 2012 114,989 50,598 13,532 6,140 80,108 265,367 2013 119,001 54,740 14,614 6,643 86,359 281,357
(unit: million dollars, %)
Rank 7 8 9 10
Country China Canada Russia Spain Total
Market Size (2009) 6,695 4,922 4,913 4,257 180,063
% 2.9 2.1 2.1 1.8 77.1
Rank 17 18 19 20
Country Brazil Sweden India Denmark
Market Size (2009) 2,219 2,195 1,986 1,891 233,651
% 0.9 0.9 0.8 0.8 100.0
2014 123,444 57,733 15,551 6,979 90,670 294,377
Annual Growth Rate (average) 3.8 7.7 8.6 7.3 6.5 5.7
World market
Note 1: The market scale of Korea (Production Exports + Imports) deduced by referring to medical devices production report Note 2: The decrease of Korean market scale in 2009 was affected by the exchange rate fluctuations in 2009 (the basic exchange rate in 2008 : 1,102 won, the basic exchange rate in 2009 : 1,276 won) Reference: The Handbook on Medical Devices Production, Import and Repair Companies (Statistics), Korea Medical Devices Industry Association, 2010
Notice : Estimation of Espicom Data : Espicom, The World Medical Markets Fact Book 2009
The most notable country with the prospect of displaying rapid market growth is China. According to the statistics, (Table 6-1-3), China is expected to grow by 10.9% annually from 2010 to 2014. Its market size to increase from 6.9 billion dollars (2.9%) in 2010 to 10.4 billion dollars (3.6%) in 2014. Its market scale is also expected to rank up from 7th in 2010 to 6th in 2014. Following Chinas rapid growth in the medical devices industry, its market share in the global market will continue to develop. This will result in more intensified competition between the Korean and Chinese medical devices industries.
According to Espicom, the medical devices market size of America was at 92.6 billion dollars (39.7% of the world market) in 2009, becoming the largest market in the world. It was followed by Japan, Germany, France, Italy and China. The 10 largest countries shared 77.1% of the global market. The market size of Korea in 2009 was 2.86 billion dollars (1.2%) and was scaled at 13th. Table 6-1-2 The Medical Devices Market Size According to Countries (2009)
Table 6-1-3 The Estimation of Medical Devices Market Scale for Each Country (2010 ~ 2014)
2010 Country America Japan Germany France U.K. China Italy Market scale 94,448 24,270 18,059 9,425 8,259 6,943 8,593 Sharing 40.0 10.3 7.6 4.0 3.5 2.9 3.6 2011 97,695 25,951 18,844 10,045 8,078 7,720 9,000 2012 101,046 27,713 19,913 10,726 9,378 8,526 9,438 2013 104,418 29,361 21,026 11,384 11,011 9,374 9,838 2014 108,090 30,061 22,117 11,924 11,406 10,489 10,109
Rank 1 2 3 4 5 6
Country America Japan Germany France Italy U.K.
Market Size (2009) 92,662 21,713 18,843 9,071 8,703 8,284
% 39.7 9.3 8.1 3.9 3.7 3.5
Rank 11 12 13 14 15 16
Country Swiss Australia Korea Mexico Netherlands Austria
Market Size (2009) 3,969 3,370 2,855 2,608 2,371 2,222
% 1.7 1.4 1.2 1.1 1.0 1.0
Annual Growth Rate (2010~2014) 3.4% 5.5% 5.2% 6.1% 8.4% 10.9% 4.1%
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2010 Country Spain Canada Swiss Total of 10 countries World medical devicess market scale Market scale 5,349 5,318 4,281 209,628 Sharing 2.3 2.3 1.8 88.7 2011 5,770 5,876 4,462 220,931 2012 6,240 6,333 4,722 234,425 2013 6,695 6,571 5,058 248,053 2014 7,132 6,896 5,376 259,302
Annual Growth Rate (2010~2014) 7.5% 6.7% 5.9% 5.5% Rate of imports depen -dence
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
Annual average growth rate -
64.8
60.3
65.6
64.0
61,0
59.5
61.4
64.7
65.8
67.5
Note 1. Value in bracket shows differences compared to last year Note 2. Market scale is calculated by production-exports+imports Note 3. The exchange rate for imports/exports use the basic exchange rate of annual average from the Bank of Korea Reference: Report on Medical Devices Production, Import and Repair, Korea Medical Devices Industry Association
236,221
100.0
249,519
265,368
281,357
294,377
5.7%
Data : Espicom, The World Medical Markets Fact Book 2009
(2) Current Status in Medical Devices Industry

The number of domestic medical devices manufacturers has increased by more than twofold in the last 10 years (from 723 to 1,857). The number of manufactured medical devices products has also increased rapidly (from 3,913 to 8,704 products). This is likely to be cause by the growth of the industry through the diversification of domestically manufactured products. In 2010, the number of medical devices production and imports companies have increased compared to the previous year along with the increase export values (22.2%). However, trade balance losses were increased due to the increase in imports (22.5%).
3) Domestic Medical Devices Industry

(1) The Trends in Domestic Medical Devices Market
The national medical devices industry has grown rapidly since 2001 and maintained the annual average growth rate at 9.4% for the past 10 years. The industry increased from 1.7 trillion won in 2001 to 3.9 trillion won in 2010. Table 6-1-4 The Trend in Korean Medical Devices Market (2001~2010)
(unit: 100 million won, %)
(3) The Measures Against Environmental Changes

As a result of the establishment of the GHTF, the global environment is changing with individual countries strengthen the protection and promotion of domestic medical devices industry development. The international community is also pushing for the development of internationally standardized policies. The need to develop and improve policies, which prioritize the consumer safety and do not deter industries growth, is being addressed by the Korean government. Furthermore, more efforts are being request to respond towards changes in domestic and foreign environment for medical devices, and to enhance the effectiveness of the medical devices safety management.
2001 Pro -duc -tion Exports Imports
2002
2003
2004
2005
2006
2007
2008
2009
2010
Annual average growth rate 10.7 13.0 10.0 8.9 9.4
11,941.0
13,481.3 13,271.1 14,781.7 17,041.6 19,491.6 22,169.7 25,252.0 27,642.6 29,644.4 (12.9) (-1.6) (11.4) (15.3) (14.4) (13.7) (13.9) (9.5) (7.2) 5,777.2 (0.4) 6,520.4 (6.1) 7,160.3 (9.8) 7,810.4 (9.1) 9,590.9 12,481.4 15,190.3 16,813.1 (22.8) (30.1) (21.7) (10.7)
5,777.2 5,753.8 (0.4) 11,411.9
11,722.2 13,592.9 14,708.0 15,461.1 17,193.2 20,014.2 23,408.8 23.988.1 26,613.9 (2.7) (16.0) (8.2) (5.1) (11.2) (16.4) (17.0) (2.5) (10.9)
-5,945.0 -7,446.3 -7,446.3 -8,300.8 -9,382.8 -10,423.3 -10,927.5 -8,797.9 -9,800.8 Trade -5,658.2 (5.1) (25.3) (25.3) (1.4) (13.0) (11.1) (4.8) (-19.5) (11.4) Balance Dome 7,704.2 -stic 6,187.2 (24.5) Demand Market Size 17,599.2 7,124.5 (-7.5) 8,261.2 (16.0) 9,881.4 11,681.2 12,578.8 12,770.7 12,452.3 12,831.3 (19.6) (18.2) (7.7) (1.5) (-2.5) (3.0)
19,426.4 20,717.4 22,969.3 25,342.4 28,874.4 32,593.0 36,179.5 36,440.4 3,9445.2 (10.4) (6.6) (10.9) (10.3) (13.9) (12.9) (11.0) (0.7) (8.2)
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3. The Direction of Medical Devices Safety Management

1) T he Reinforcement of Pre-to-Post Management for the Safe Use of Medical Devices by the Consumers
The increase in the use of home medical devices is reflected by ageing and wellbeing trends, and false and excessive advertisements of home medical devices prevalently targeting vulnerable social groups. As a preventive measure to protect consumer from such advertisements, the government have established a preassessment system for medical devices advertisements and has been operating it since April 2007. For the effective operation of the system, the KFDA monitors major media. The administration also established an information search service for advertisement pre-assessments through KiFDA system. Also, based on the growth of the medical devices market, observed by the rapid increase in number of home medical devices and frequently use of high-risk medical devices, there is a possibility of faulty devices being distributed in the market. Hence more effective pre and post management systems are being requested to address such complications. The KFDA will designate quality control targets, which subsequently will be collected for inspection every quarter to assure qualities of medical devices available in the market. Furthermore, the KFDA will strengthen its management for medical devices categorized as target-management products that can cause negative impact in the society if any adverse effects occur. The administration will also enforce its recall and destroy system for faulty devices. A project has been planned to reassess medical devices that was approved a long time ago, to assure their safety and efficacy are at the standard of the latest medical devices technology.
clinical trials policy and regulations to level with international standards. The KFDA is also developing clinical trials programs to train experts to involve major domestic companies in medical devices industry and assist existing devices companies to enter the global market. The KFDA will also focus in establishing a productization base and support system for efficient productizations of new technology medical devices. This includes selecting domestic endobot technologies with productization date near, to assist them in policy procedures and provide them with relevant information in approvals, such as clinical trials, safety & efficacy assessment and GMP inspections.
3) Internally Stable Operation of GMP to Improve Quality of Domestic Medical Devices

The KFDA organized various GMP training programs, guidelines for safety management inspections and sterile validation, and test-operation of on-site inspections for foreign medical devices manufacturers, to establish quality management infrastructure since GMP application became mandatory in May 2007. The focus now has shifted from policy settlement to internally stable operation for the purpose of improving the quality of domestic medical devices and international harmonization. First of all, the KFDA will improve the overall standard of GMP operation in smallmedium sized businesses by providing customized GMP assistance and trainings to educate staffs responsible for quality-management of products. A self quality management system for 1st grade medical devices, which have no potential risks, will be introduced. This will boost the effectiveness of administration procedures by selectively managing medical devices of 2nd ~ 4th grades that have relatively higher associated risks. It will also harmonize their GMP inspection to international standards. The administration is also to improve its current quality assurance abilities by introducing on-site GMP inspection scheme for foreign manufacturers and indirect confirmation of GMP certificates, which are to assist in the importation of high quality devices.
2) P romoting Medical Devices based on New Technologies and Establishing International Competitiveness in Their Quality
Even through medical devices development is becoming more frequent, there is a delay in the devices productization and introduction to the global market due to lack of infrastructure in clinical trials that are essential in confirming safety and efficacy of devices, which incorporates new technologies. The KFDA is reviewing its
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The KFDA unified the approval and evaluation process to simplify the tasks involved. The technical document review and item approval are now unified, minimizing unnecessary time taken during civil affairs. To simplify the system, each product type
02
Improvement of Medical Devices Pre-Management System
was given a responsible inspection department.
3) Current Condition in Improving Major Tasks involved Approval and Evaluation System
The three bureau under the Medical Devices Evaluation Department (Diagnostic Medical Devices Division, Therapeutic Medical Device Division and Medical Materials and Supplies Division) are attempting to simplify approval and evaluation process, increase efficiency of approval management, internationally harmonize standard & specification and product categorization, and expand transparency and objectivity of approval and evaluation system. Introduction of Excellent Medical Devices Inspection System to secure (1) consistency and professionalism Operation of 3-Helplines (medical devices approval/evaluation conference) (2) Approval assistance system for products such as new technology integrated (3) medical devices Private sector consignment on technical document review of 2nd grade medical (4) devices Model operation of pre-assessment system on medical devices approval and (5) evaluation
1. Overview and Current Condition of Medical Devices Approval and Evaluation System
1) Overview of the Approval and Evaluation System
The technical document review of medical devices inspects the safety and performance of a device that integrates various advanced technologies, such as medical engineering, electroengineering, physics, chemistry, biology and material engineering. Hence it requires specialized experts from multiple fields of technology. Difficulties have been experienced in evaluations as a small number of experts are reviewing and assessing medical devices that incorporate technologies from various fields. Nonetheless, they are doing their best to handle fast-paced changes of the market environment under the aim of promoting the development of medical devices industry.
2) Approval and Evaluation System

Figure 6-2-1 Task Process of Medical Devices Evaluation Department
Approval/Supplementation Classification of civil affair Technical documents screening Approval screening
(6) Rationalization of sterilized medical devices review data (7) Expansion of approval scope on manufacturers performance data (8) Expansion of biological safety test exemption category (9) Conversion for 1st grade medical devices to submit list
Receipt
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2. Current Condition of Medical Devices Approval and Evaluation System

1) Overview of Item Approvals
(1) A Medical Device is Categorized as 1st, 2nd, 3rd or 4th Grades According to Its Potential Risks
- 1st grade: registration in regional KFDA - 2nd~4th grade: Request for approval at KFDA headquarter Table 6-2-1 Number of Medical Devices Categorized by Grades
Classification Item classification Total 2,059 1st grade 587 2nd grade 931 3rd grade 301 4th grade 240
2) Civil Affair Processes

(1) C ivil Affairs Process Related to Approval and Evaluation in 2010 (Table 6-2-2)Civil Affairs Processes in 2010
Table 6-2-2 The Actual Condition of Civil affairs Process Related with Authorization-Inspection in 2010
Class (legal process period) Total Business permission New 21,978 Manufacturing (25 days) Imports (25 days) Sub total Approval (10 days, 65 days, 80 days) Item permission Registration (10 days) (at Regional KFDA) Sub total Technical documents (55 days, for change 32 days) Technical document review Safety-effectiveness inspection (70 days) Sub total Clinical trials Clinical trial plan review (30 days) Inquiries (7 days) Others English certification (3 days) Reissue (7 days) Sub total Change 12,029 445 447 892 5,384 3,936 9,320 1,780 37 1,817 30 Total 34,007 752 657 1,409 8,528 8,767 17,295 4,483 159 4,642 99 1,564 8,047 1,050 10,661
(2) C ivil Affairs Associated with Item Approvals

- Item approval, technical document review: 3 offices within Medical Devices Evaluation Department (33 staff members) - S afety-efficacy evaluation: 3 offices within Medical Devices Evaluation Department (33 staff members) - Issue of test-inspection certificate: 13 test organization (KFDA registered)
3. Technical Document Review for Medical Devices

The medical devices technical document review for a document that contains the name of the product, amount of raw materials or ingredients, shape, structure, size, production methods, performance, purposes, operation or usage methods, packaging
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unit, storage methods, service life, test specifications, and other relevant information. It is a requirement in item approval and is stipulated by Articles 4, 5, 17 and 18 of Enforcement Regulation of Medical Devices Act, and targets 2nd, 3rd and 4th grade medical devices as classified by Medical Devices Act. The review inspects the safety and efficacy of medical devices that were produced with integrated technologies. For this reason, the Medical Devices Evaluation Department is composed of experts from various technological areas, who assess different data to secure the safety and efficacy of these products. The KFDA established a common standard (KFDA notification) on electromechanical safety of medical devices that use general electricity. Also, a common standard (KFDA notification) on biological safety is for devices that are either inserted or comes in contact with the human body. Standards for individual products, such as blood storage container, are also developed to apply them in the review. In 2010, the KFDA conducted 4,483 reviews, and the pass rate and reject rate are 83% and 17%, respectively (Table 6-2-3). As shown in (Table 6-2-4), the major countries of import are Europe, America and Japan respectively. The imports from America and Japan have increased little to 988 (30%) of total imports, but imports from Europe and other countries were marked at 33% (1,090 cases). This shows diversification among import countries. Improving Medical Devices Technical Document Reviews The medical devices technical document is a technical document that confirms the safety and efficacy of products, and the technical document review is an essential procedure to evaluate the safety and effectiveness of products. These reviews require professional knowledge as they include product development principles, technical features and test reports. For these reasons, clear review standards and a direction in standardized technical document are necessary. The KFDA developed a measure to improve (proposed) the document review system in 2006 to harmonize with review systems of other advanced countries. For such standardization, the administration amended an overall structure of a technical document, introduction and test report formats, a conformity declaration form and a check lists.
Table 6-2-3 Technical Document Reviews on Medical Devices (New Format)

In Process Year 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 Total 4,241 5,013 5,336 3,834 4,463 4,281 4,745 4,410 4,161 5,518 5,262 Carryover 581 611 717 625 391 427 457 591 931 669 735 Receipt 3,660 4,402 4,619 3,209 4,072 3,854 4,288 3,891 3,230 4,849 4,527 Total 3,630 4,296 4,712 3,547 4,036 3,967 3,920 2,888 3,492 4,114 4,483 Pass 2,787 3,275 3,631 2,703 3,405 3,153 3,131 1,962 2,229 3,308 3,759 Rejected/ Canceled 843 1,021 1,081 844 631 814 789 926 1,263 806 724 Complete 611 717 624 287 427 457 591 931 669 735 779
Table 6-2-4 Technical Document Review Received (per Manufacture/Countries/ Category)

Year 2000 2001 2002 2003 2004 2005 2006 2007 2008 Receipt 3,660 4,402 4,619 3,209 4,072 3,854 4,288 2,793 3,230 Country Korea 1,069 1,704 1,941 1,331 1,794 1,643 1,896 1,040 1,152 America 1,000 933 92 324 746 723 793 611 731 Japan 378 423 328 238 305 311 261 155 257 Europe 953 1,029 1,177 798 905 841 759 723 811 Etc. 260 313 271 218 322 317 579 264 279 2nd 3,126 3,909 4,033 2,564 3,207 2,350 2,528 1,634 1,854 Grades 3rd 444 486 565 638 682 1,055 1,319 812 955 4th 177 433 412 314 409 Etc. 7 21 7 6 16 29 33 12
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Figure 6-2-2 Medical Devices Technical Document Review by Country (2008)

Others : 579 (24%) America : 793 (33%)
The medical devices, which were approved through safety-efficacy evaluation in 2010, are listed below. Figure 6-2-3 Medical Devices Approved through Safety and Efficacy Assessment
Europe : 759 (32%)
Japan : 261 (11%)
4. Safety and Efficacy Evaluation of Medical Devices

When compared to medical devices that were previously approved or registered, both new medical devices with different performance or purpose and new technology incorporated medical devices that have specialized raw materials or displays different technology, must submit reports on development procedure and clinical trials data, additional to already requested data in normal technical document reviews. Table 6-2-5 Clinical Test Data Submission and Approval Status (Dec 31st, 2010, unit:case)
Class Received Approval Approval rate(%) Total 359 155 43.2 02 30 8 26.7 03 23 10 43.5 04 25 13 52.0 05 18 8 44.4 06 33 14 42.4 07 31 14 45.2 08 41 25 61.0 09 49 25 51.0 10 109 38 35.8
Artificial toric crystalline lens Medical low temperature device
High strength focusing type ultrasonic wave operation device
Digital breast shooting X-ray device
5. The Medical Devices, Which Were Approved through Safetyefficacy Evaluation in 2010, Are Listed below.
1) Explanatory Sessions for the Public
The active supply of relevant technical information at government level are essential for small-medium sized medical devices businesses. For this reason, the Medical Devices Evaluation Department organizes explanatory sessions, focusing on the needs of consumers. These sessions represent that the administration is shifting its focus from policy to the cooperation with the industry to promote their development and involvement.
Table 6-2-6 Safety and Efficacy Evaluation Status

Class Total Technical document reviews Manufactured item approval (in batch) Imported item approval(in batch) Total 161 92 25 44
(Dec 31st 2010~Jan 1st 2011, unit: case)
Safety-Effectiveness New 122 87 11 24 Changed 39 5 14 20
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Table 6-2-7 Major Seminars and Explanatory Sessions Organized in 2010

Presentation Change & Jump 2010 Comprehensive presentation The 5th debate, Change & Jump 2010 general presentation Content Medical devices enhancement measures Technical support for GMP hazard management Discussion between the KFDA and the industry on approval and evaluation in medical materials and supplies sector Amendments on policies for approval targets in medical devices Measures in promoting pre-assessment system Information disclosure including medical devices approval and evaluation Improvement measures for medical devices approval and evaluation system to promote market access Date 2010.2.3
6. Provision of Technological Information and Method of Safe Use of Medical Devices for The Public
The KFDA published guidelines and technical document reporting methods for major medical device products to achieve a standardized and scientific, international harmonization and increase civil accessibility. The administration provided assistance to the public by increasing the predictability in the required documents for submissions and enhanced level of medical devices quality management.
2010.6.30 2010.5.24
The 6th debate CEO open floor
2010.10.13 2010.11.16
1) Guides on Technical Document Review Preparation Published to Actively Provide Relevant Information to the Public
Guideline on medical ion therapy device approvals and technical document (1) preparation Guideline on magnetic resonance computerization tomography device approvals (2) and technical document preparation Guideline on dental material approval and technical document preparation (3) Guideline on electronic operational equipments approval and technical document (4) preparation Guideline on technical document preparation for medical image processor and (5) its software Guideline on technical document preparation for potential generator (6) Guideline on technical document preparation for extracorporeal shock wave (7) treatment device Guideline on technical document preparation for ultrasonic image diagnosis (8) device Guideline on technical document preparation for paraffin bathtub (9) Guideline on skin resistance measuring instrument approval and technical (10) document preparation Guideline on optometry refractive power measuring instrument approvals and (11) technical document preparation Guideline on technical document preparation for medical endoscope (12) Guideline on technical document preparation for medical scooter (13)
2) Medical Devices Committee Activities for Medical Device Safety and Efficacy Evaluation
The development of medical devices with new technology is increasing, following the development of scientific technology. Factors in medical device that affect on safety-efficacy are variable according to their individual features. Also, the number of products, which demands safety-efficacy assurance, are also increasing. In order to manage these products, the KFDA is operating a new development department committee within the medical devices committee. The major activities of new development department committee in 2010 are listed below. Hosting committee consultation for the review of the validity of clinical test data on tissue repair material for penis enlargement (Nov 24, 2010) Hosting committee consultation for the review of the validity of clinical test data on Cilostazol and Paclitaxel (Dec 15, 2010) The labeling of the products being used for serious aortic stenosis, which apply cardiothoracic surgery aorta valve substitution cannot be applied, as rare medical devices. (Dec 15, 2010)
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Guideline on technical document preparation for electric wheelchair (14) Guideline on technical document preparation for (electronic) thermometer (15) Guideline on technical document preparation for ultrasonic wave stimulation (16) device Guideline on technical document preparation for blood pressure gauge (17) Guideline on personal combination stimulation approval and technical document (18) preparation Guideline on personal super heater approval and technical document (19) preparation Guideline on artificial kidney filter approval and technical document preparation (20) Guideline on infrared light device approval and technical document preparation (21) Guideline on technical document preparation for gene amplification device (22) Guideline on airway hearing aid approval and technical document preparation (23) (24) Guideline on laser surgery item approval Guideline on technical document preparation for treatment device (25) Guideline for medical device performance test (26)
03
International and Scientic Approaches to Medical Device Standards and Specication
1. Overview
Korea is actively participating in a Global Harmonization Task Force (GHTF), which was led by 5 advanced countries (America, Japan, EU, Canada and Australia), to achieve international standardization of domestic medical devices technology and international harmonization of its management control system. In 2006, the KFDA hosted Asian Harmonization Working Party (AHWP) in Korea. Although the KFDA is preparing its management standards to meet international levels by specialized item categorization and reorganization, an establishment and amendment of its current standards and specifications became necessary to develop domestic technologies and enhance competitiveness of the industry.
2. Current Status in Medical Devices Standards and Specifications

The medical device standard plays a crucial role as an indicator of quality management as well as for improvement in their safety. Through the various researches, Korea has established three common standards and specifications (electro-mechanical safety, biological safety, and electromagnetic wave safety) and 124 individual standards and specifications to apply them in safety assessments of medical devices. Aside from above mentioned 127 standards, Korea is utilizing international standard such as the IEC and ISO for approval and management, similar to advanced countries such as America, Europe and Japan. The KFDA also established and released a
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standard information database system on the KFDA website, which is identical to the Recognized Consensus Standards' of the American FDA, to provide the necessary information for the development and approval of medical devices. Figure 6-3-1 Provision of Information on Standards Applied for Medical Devices
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Establishment of Medical Devices Quality Management System
1. Defining GMP System for Medical Devices

1) Purpose in Introducing GMP System for Medical Devices
GMP system for medical devices is a part of high quality assurance procedure Table 6-3-1 Current Medical Device Related Standard
Individual Standards Class Number of standards Common standard 3 Electronic medical device standard 62 Medical device standard 62
to certify that the device is safe, effective, conforms to its intended use and be produced in a consistent manner. In Korea GMP system was introduced in 1997, as a recommendation by High Quality Medical Equipment Production and its Quality Management Standard, during which medical devices were managed by the Pharmaceutical Act. GMP system became mandatory from May 30th, 2004, after the introduction of Medical Devices Production, Import and Quality Management Standards published based on ISO 13485 as a part of the Medical Devices Act. Hence,
3. Future Directions
The KFDA will continue to develop new assessment technology that reflects the scientific development and addresses safety assessment methods. It will also develop and apply standards and specifications for various medical devices. Furthermore, they will revise existing individual standards for their international harmonization to assist in the enhancement of national health.
any medical devices manufacturer, medical devices importer and medical devices for clinical trials manufacturer that sell or distribute products without applying GMP system are subjected to administrative measures.
2) Early Establishment and Application of GMP System

GMP for medical devices became mandatory with the initiation of Medical Devices Act on May 30th, 2004. Following such measure, those who wished to become medical devices manufacturers and importers, and manufacturers of medical devices for clinical trials had to implement GMP system. Those who owned above businesses prior to the implementation were given an implementation period of 3 years, after which mandatory GMP was necessary. For efficient implementation of GMP system,
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an information section for GMP was prepared for businesses and industries in KFDAs website, providing relevant information such as guidelines, related data, risk management, validation and technical assistance. As a result, a total of 3,291 companies, 1,838 manufacturers and 1,453 importers, received GMP certification to December 2010.
2) Various Guidelines for Small-Medium Sized Manufacturers

The medical devices GMP system became mandatory in May 2004 and existing companies implemented GMP by May 2007. During the preparation period, the companies appealed to the KFDA on various issues, which was used to publish guidelines to reduce confusion or difficulties experienced by the industry in the GMP implementation.
2. Improving GMP Operating System and Its International Standardization

1) GMP Inspection Method
GMP conformity assessment of medical devices was performed in conjunction with 4 other quality management evaluation organizations that were registered at the KFDA and medical devices monitoring institute of the KFDA. The management operation standards of evaluating organizations are of international standard (ISO/IEC Guide 62). The KFDA assesses, directs and guides suitability of quality management tasks annually to improve the evaluation process. Figure 6-4-1 Overview of Evaluation Procedure
(1) G MP Operation Guideline for Small to Medium Sized Medical Devices Manufacturers
The guideline for GMP operation and application cases is suitable for small-medium sized manufacturers that shares 80% of domestic medical device manufacturers. It was aimed to help early implementation of GMP system and enhance its operation.
3) Technical Support on Overall GMP Implementation Including Risk Management

Risk Management is an advanced safety management system, which analyzes and evaluates every risk from overall procedures, including product design, production and usage, and manages such risks within the scope of an acceptable level.
Pre-evaluation
application receipt evaluation plan consultation pre-review
The KFDA applied high level quality management techniques, such as risk management, sterile validation and software validation, as a mandatory requirement since May 31, 2007. The administration applied ISO 14971 as a risk management method similar to other advanced countries. The KFDA has also been conducting customized technological assistance for overall application of GMP, focusing on the risk management and validation, since 2008 to improve current GMP operation status to the international standard and to establish a solid basis for high performance medical devices productions.
Openning Meeting Regulatory Audit
Main evaluation
Quality Management System Aduit Aduit Reporting Closing Meeting
Decision making
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(2) G uidelines on Medical Device Risk Management (Categorized by Item)

The KFDA conducted guideline development researches to apply standards during GMP inspections. This involved studying relevant cases on risk management. As a result, guidelines of risk management for various products were produced. (2008: 21 items including syringes, 2009: 13 items including respirator, 2010: 13 items including body fat measuring device)
fit to international settings. Furthermore, adequate education on risk management, sterile validation and software validations, which are high level quality management methods, should be taught to relevant businesses. Hence the KFDA has developed various educative contents and specialized GMP education programs.
6) International Harmonization of GMP Inspections through Differential Management

Current GMP inspections carry out conformity assessments for all the device grade and items under the same standards. This causes difficulties in focused management of high-risk devices and creates burdens in managing low-risk devices. Hence, a differentiated management system by medical device grade and item types is needed. The KFDA introduced categorized GMP assessment system to be applied inspections for clinical or other medical devices. The KFDA introduced self quality management system of companies that produce 1st grade medical devices (some products such as sterilizing items are not applicable) to achieve international harmonization of GMP inspection. Meanwhile, focus can be n 2nd~4th grades, which have relatively higher risks, and thus, enhancing of administrative efficiency and medical devices safety.
4) I ntroduction of on-site Inspection Scheme for GMP Implementation in Freign Manufacturers

The market share of imported medical devices in the domestic medical device market is at 65%, formed largely of 3rd~4th grade medical devices, which have a higher risk level. Hence, Korea needs on-site GMP inspections like America, EU and Japan to inspect foreign medical device manufacturers. Up until now, the confirmation of quality management for imported medical devices was carried out by checking the GMP certificates without on-site inspections. The KFDA improved such system and introduced on-site inspection scheme for foreign manufacturers, based on the result from the trial operation of 2007~2010. The scheme allows equal treatment for both domestic and foreign manufacturers and direct confirmation of the quality management of imported medical devices.
| Note | What is the GMP mark system ?
5) R einforcement of GMP Training for Medical Devices Manufacturers

A stable of operation of GMP is only possible when the CEO, the staff member in charge of product quality management and the whole staff of a manufacturer or importer are fully aware of the system. Hence, GMP standards put emphasis on the training of staff members. Recently, many countries are actively signing Mutual Recognition Agreement (MRA) in medical device approval and evaluations. For Korea to be a part of the global market, detailed operational standards of GMP must be reorganized and revised to
The GMP mark system is a quality assurance system, which was introduced in June 2007, to allow easier identification of products that received GMP certification by the consumers. The GMP mark is labeled on the products of manufacturers, which received the GMP certification, and can help to improve qualities of distributed medical devices through the GMP Mark elimination of unmarked products. Furthermore, it is expected to improve the quality of imported medical devices once on-site inspection for foreign manufacturers are implemented and above mark provided. The KFDA is planning to develop a GMP mark system similar to the CE mark of EU.
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2. Establishing a Reasonable Post-Management System Focusing on Safety

1) Medical Devices Advertisement Management System to Protect Consumer from False or Exaggerated Advertisements
The demand on medical devices has been increasing due to ageing and wellbeing trends, and false and exaggerated advertisements on medical devices are also becoming prevalent due to the introduction of various advertisement outlets. Recently, imprudent advertisements on medical devices, especially targeting elderly
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Strengthened Post-Management of Medical Devices
1. Overview
There was a sudden increase in the demand of home medical devices due to changes in cultural trend and rapid development of medical devices industry after the implementation of Medical Devices Act in May 2004. This led to sales and distribution of defective and fraudulent medical devices. The KFDA is actively engaged in the crackdown of unregistered devices, collect and inspect defective devices and supervise that advertisements for medical devices are not false or exaggerated to protect consumer health and relevant industry. The KFDA also prevent possible hazardous implication by collecting medical device adverse events reports from within and out of the county, which in turn are released to the public. Figure 6-5-1 The Basic Direction of Medical Devices Post-Management
The Basic Direction of Medical Devices Post-Management
Improvement of crack down efficiency : Termination of regular monitoring Switching to the autonomous check-evaluation system The reinforcement of planned monitoring on the problem reported products Securing quality of distributed medical device : Performing of the quarterly non-scheduled collecting-examination Extermination of false-exaggerated advertisement : Operation of special agents on illegal advertisement monitoring Safety re-confirmation of distributed medical device : Implementation of re-evaluation on medical device (2 times) Activation of safety information including side effect report : Establishment of activation measure including expansion of safety information training Management of trace-targeted medical device : Adjustment of designated target and inspection on current status of control
population, are causing concerns in regards to possible consumer health implications. The KFDA introduced medical devices advertisement pre-assessment system in 2007 that enforced mandatory review of advertisements made on daily newspapers, monthly magazines, television broadcasts and internet. In the late 2010, a total of 1,801 reviews were completed to exterminate misleading or exaggerated advertisements and to establish reasonable standards for effective response to products, whose advertisements were not reviewed. In 2010, the KFDA completed joint crackdown on companies that sold unauthorized medical devices with regional KFDA and government. These companies especially targeted senior citizens, giving them free trials of the devices and providing false and exaggerated advertisements. A total of 105 companies were caught during crackdown that was conducted twice, one early and one late during 2010. Another example of strengthened post-management system is the employment of medical devices monitors that surveys advertisement sources such as newspapers and the internet, to check for false and exaggerated advertisements. Also, an inspecting medium has been designated at each of the regional offices, to prevent duplicated inspections. These measures show effective mechanisms of which the KFDA employed to strengthen post-management of medical devices.
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Figure 6-5-2 Illegal Medical Device Advertisement Caught in the Last 3 Years
Year exposure (case) 2008 233 2009 278 2010 444
the reports for other businesses, and prevent hazardous factors in advance. The KFDA established internet reporting system through K!FDA network to assist the publics accessibility. Medical Devices Safety Information Reporting including Adverse Events shows that cases have increased by 5.7 folds in 2009 compared to 2008. In case of 2009-2010 comparison, it has increased by 6%. Figure 6-5-3 S afety Information Reporting Status (Inc. Domestic Adverse Events Reporting) in the Past 4 Year
2500 2000 1500 1000 500
autonomous collection side effect report safety information
The KFDA is to uncover issues in the advertisement pre-assessment system for its successful implementation and update assessment results on its website for the public access in 2011. It will cooperate with the Korean Senior Citizens Association to prevent fraudulent cases of medical devices affecting vulnerable citizen groups, such as elderly or women population. The KFDA will also be actively engaged in educating and promoting associated risks, to minimize complications due to misleading advertisements.
2) P revention of Risk Factors in Medical Devices: Adverse Events Reporting, Trace Management and Reassessment.
Current trend in medical devices is that the use of personal and higher-risk medical devices, such as ones that get inserted into a human body, are increasing due to ones interest in maintaining healthier life and advances in medical device technology, respectively. Finally, changes in cultural trend caused the public be more alert about the product safety. Since the initiation of Medical Devices Act, the KFDA is continuously revising relevant regulations and employing experts to prepare suitable environment for the effective medical devices safety management, especially for in assuring safety and efficacy of the devices. Furthermore, designation of trace management devices, adverse effect reporting and medical devices reassessment are tools established for efficient postmanagement of medical devices. By utilizing these tools, the KFDA will be able to prepare preventive management for distributed medical devices and enhance relevant domestic industry standards. The safety information report system, such as adverse event reports, allows those who handle medical devices to recognize the associated issues autonomously. The KFDAs role is to review such issues and prevent additional complications by relaying
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According to the Medical Devices Act, medical devices can cause critical damage to the human body during the usage from their adverse effects or faulty functions. Hence, devices that require trace-work has been designated to be managed through written records. This is done by the medical device manufacturers, importers and sellers and by those who opened the medical businesses. Until recently, the KFDA managed 8 products as trace-management targeted medical devices. It recognized that implantable cardiac impactor electrode and cardiac impactor needed to be designated as trace-management targets, and were added to the list subsequently (KFDA notification 2008-85, Dec 30, 2008). The administration also eliminated or decreased irrelevant products from the list. Minimizing Targeted Medical Devices (May 29, 2009) - Elimination of external artificial cardiac pacemaker and minimization of implantable medicine impregnator products
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Figure 6-5-4 Current List of Domestic Trace-Management Targeted Medical Devices

The trace control targeted medical device The medical device which was inserted in human body for over 1 year
Implantable mechanical heart pacemaker The electrode for implantable mechanical heart pacemaker Mechanical heart valve Implantable heart impactor Implantable drug injection pump item reduction (May. 29. 2009)
For the last 3 years, 2,969 reports on domestic safety information were made although it is still insufficient compared to reports made in the US and Japan. This largely due to insufficient awareness of the person in charge on medical devices and the difficulty to determine whether the occurred adverse event is a target of reporting or not. The KFDA will expand its education and training programs, and establish and provide Guidelines on Medical Devices Adverse Events Reporting to medical devices manufacturers, importers and healthcare workers. In 2011, the KFDA will establish a Medical Devices Safety Information Monitoring Center in 6 domestic medical organizations for active adverse events reporting. The administration is also to perform medical devices reassessment for 609 products, including soft contact lenses, which gained item approval before the implementation of common standard. The purpose is to reinforce national health safety standards through the elimination of risky medical devices from the market and promote distribution of high quality medical devices only.
The medical device which can be used outside of the medical organization from the life-support medical devices
Respirator (for constant wearing only) External mechanical heart pacemaker

removed (May. 29. 2009)
Silicon gel implant breast The electrode for implantable heart impactor
item added (Dec. 30. 2008)
Heart impactor
item added (Dec. 30. 2008)
The medical devices reassessment is a system built to reflect and manage strengthened standards and specifications, and address issues raised after the distribution of the product. In 2010, the KFDA arranged reassessments of 205 products, such as laser operators and electronic operators, which were authorized before the implementation of the common standard. Figure 6-5-5 Medical Device Reassessment Flowchart
Designation of target item The medical device committee review the target item, requested period, submitted papers.
4) Collection and Inspection of the Quality Reinforcement of Distributed Medical Devices

The KFDA conducted quality assessment for various distributed medical devices from home medical devices to those for insertion into human bodies. The quality assessment was accomplished to confirm if devices have equivalent safety and efficacy compared their approval records. If deemed unsuitable, the KFDA will enforce administrative measures, including a product recall. In 2010, the KFDA carried out quality assessments for 251 products, including personal heaters, and of these, 62 products assessed to be unsuitable. These products subsequently received administrative measures, and those products that partly deviated from the previous records were recalled. The KFDA established systematic collection standards and steps through the revision of Guidelines on Medical Devices Collection and Discard to strengthen public health.
Item illustration
Notify one by one by homepage or mail till 1 year before the re-evaluation
Re-evaluation application
Submit (request) the needed data for re-evaluation including copy of the item license certification
Reading of the evaluation result Notification of re-evaluation
Reading of the re-evaluation draft proposal (1 month)
Notification of re-evaluation result on the item after the end of draft proposal reading
Follow up action
Actions including change of the re-evaluation result
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Table 6-5-1 Medical Devices Collection and Assessment Records in the Last 5 Years
Class 2006 2007 2008 2009 2010 Products 117 137 145 289 251 Result Suitable 76 125 137 261 189 Non suitable 41 12 8 28 62
Figure 6-5-6 M edical Devices Self Assessment Details

Target : Manufacturing(GMP), Import(GIP), Repairing
Except the companies which completed first-regular inspection from Apr. 1. 2009 to Mar. 31. 2010 for the year they completed the inspection.
Period : 1 time a year

The first half of the year (3.1 ~ 3.31) for the manufacturers, importers, repairing companies.
Required papers : Company current status card, check list, evaluation report Evaluation method : A ~ E (5 steps relative evaluation)
Details of autonomous check evaluation Submission method : paper or CD (regional KFDA)
Since its model operation in 2009, the participation rate has increased (Table 6-5-2)
5) S ystemic Changes in Post-Management of Medical Devices (Implementation of Self-Assessment)

The ability to self assess the medical devices by their manufacturers and importers is improving due to the implementation of Good Manufacturing Practice/Good Import Practice (GMP/GIP) conformity certification system that is based on the international standard of ISO 13485. This is strengthening the safety and quality of market distributed medical devices. Based on such improvement, the KFDA abolished regular medical device monitoring system, which made the administration visit the manufacturer or importer or repairer to confirm that they were abiding to the relevant regulations. From 2009, the KFDA initiated Medical Devices Self Assessment for the business owners to check themselves against the regulations and report the result to the responsible regional KFDA office. This self assessment is conducted on an annual basis and targets medical devices manufacturers and importers that received GMP/GIP certification. The assessment is based on the documents submitted by the business owners and assessment items are based on Medical Devices Production, Importation and Quality Management System (GMP/GIP).
in 2010 as a result of civil presentations and regular training to improve participation rates. Table 6-5-2 Regional Participation Rates of Self Inspection Assessment
Class Manufacturing Import Repairing Total Total 996 833 695 2,524 Participation 676 675 414 1,765 Non participation 320 158 281 759 Participation rate compared to previous year 2009 49.6% 70.7% 31.6% 2010 67.9%(18.3%) 81%(10.3%) 59.6%(28%)
In 2011, the KFDA will request the entire medical device manufacturers and importers to conduct self inspection assessment. Based on the assessment result, any companies that did not participate or were deemed inadequate (trainings to be provided) will be given options for further surveillance and inspections to ensure the safety of products. The KFDA is also to implement Good Sales Practice (GSP), which is additional to GMP/GIP, for managing import and production and to manage issues raised during the sale and distribution of medical devices. GSP is to be followed by medical devices merchant and renters and will support the KFDAs aim to ensure safe trade and distribution of medical devices.
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Chapter 07
Food and Drug Safety Assessment

01 Building Advanced Foundation for Scientific Risk Assessment 02 Enhancement of Status as an International Institute for Test Analysis and Research 03 Providing Scientific Basis for Advanced License Screen System and Safety Management 04 Improvement of Status of the Institute as an International Safety Evaluation Institution through the Enhancement of Safety Evaluation Technique 05 Upgrading National Prestige through Enhancing International Cooperation
1. Building Advanced Foundation for Scientific Risk Assessment 2. Enhancement of Status as an International Institute for Test Analysis and Research 3. Providing Scientific Basis for Advanced License Screen System and Safety Management 4. Improvement of Status of the Institute as an International Safety Evaluation Institution through the Enhancement of Safety Evaluation Technique 5. Upgrading National Prestige through Enhancing International Cooperation
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Food and DrUg Safety Assessment
to final consumption stages of food preparation including manufacturing processes. Finally, risk assessment should build realistic exposure scenarios by considering various factors. However, in case of groups with higher sensitivity to harmful substance or display higher risks, the substances acute, chronic, accumulated and combined effects must be considered. For vulnerable groups such as pregnant women or children, a more careful investigation and analysis is required, and various circumstances should be considered when developing a scenario.
01
Building Advanced Foundation for Scientic Risk Assessment
1. Overview
Recently, determining health risks and establishing standards of foods, cosmetics and herbal medicines are gaining importance. This is due to the increased awareness of the public regarding their health and food safety based on enhanced standards of living. Risk assessment may function as a communication tool, and such a role is crucial in resolving the publics concerns on health risk factors. Furthermore, it can be served as a scientific basis in establishing policies for risk management. National Institute of Food and Drug Safety Evaluation (NIFDS) developed safety standards for food with health risk concerns and prepared grounds for risk assessments and new assessment technologies to strengthen its pre and post management to protect the health of the public. Relevant Act: Article 15 of Food Sanitation Act, Article 20 of Framework Act on Food Safety, and other Acts such as Pharmaceutical Affairs Act and Cosmetics Act)
1) Chemical Risk Assessment

Risk assessment is performed in 4 stages: Hazard Identification, Hazard Characterization, Exposure Assessment and Risk Characterization. The assessment must allow re-assessment possible when new scientific facts are discovered through clear and systemic documentation of risk assessment procedures. - Hazard Identification: Identify health risk of a substance by considering key information reviewed during the research and analysis of recently collected domestic/international data (such as physical specification, toxicity and other relevant facts of a risk factor). - Hazard Characterization: Describe procedures to quantify the risk impact based on the target substances human or animal toxicity data, such as toxicity count (NOAEL and BMDL) and daily intake standards (TDI and ADI). - Exposure Assessment: Describe different types of statistical models (exposure formula) and methods for each risk factor, which is employed for a quantitative assessment of exposure to the human body, by setting up hypothetical scenarios
2. Principles of performing Risk Assessment

Risk Assessment is performed in 4 stages: Hazard Identification, Hazard Characterization, Exposure Assessment and Risk Characterization. Risk Assessment should primarily refer to data that reflect domestic situations. Data from international organizations or foreign countries may also be used when domestic data is insufficient or is not available. It also must consider analysis methods, sample collections and testing, and exposure frequencies that are conducted throughout the entire supply
based on relevant exposure data such as the amount of intake. - Risk Characterization: Describe the likelihood of human health risk in terms of risk index (in %), excess risk for carcinogenicity and MOE, based on results from two previous stages of Hazard Characterization and Exposure Assessment.
Chemical risk factors of foods, herbs and cosmetics: Pesticide residues, veterinary medicine residues, environmental pollutants, naturally-occurring toxins, mycotoxins, food additives, chemicals derived from containers and packages, and etc.
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2) Biological Risk Assessment

Risk assessment is performed when establishing standards or responding to incidents/accidents or managing problems with social implications. It is performed in 4 stages: Hazard Identification, Hazard Characterization, Exposure Assessment and Risk Characterization. - Hazard Identification: Investigate and analyze data (route of infection and clinical symptoms) of recently reports national and foreign sources. - Hazard Characterization: Suggest available model (Exponential, Beta-poission, Weibull-gamma) to determine the amount of microorganism that can develop risk implications. - Exposure Assessment: Suggest an assessment model to measure human exposure level per either single or daily intake by predicting the growth rate of microorganisms in major food with risk concerns. - Risk Characterization: Suggest risk levels in patients and FSO by running simulations based on results from two previous stages.
Biological risk factors of food, herbs and cosmetics: infectious bacteria, toxin-producing microorganisms, molds, parasites, viruses and etc.
Table 7-1-1 Risk Assessment Performed in 2010 (by Type)

Type Chemical substances such as residual pesticides Pollutants such as heavy metals Hazardous substances from production process Microorganisms Food additives Cosmetics Herbal Medicine General ingredients Subtotal Major Target Agricultural products Wine Food Marine products, and etc. Snack foods Cosmetics Herbs Foods Ingredient Isotianil, and etc. Lead, aflatoxin, and etc. Benzopyrene, and etc. Cases 108 13 3 2 1 7 1 1 136
Staphylococcus aureu , and etc.

Tar color Nickel, Aluminium, etc. Cadmium Hydrogen cyanide related with linseed
For the purpose of increasing the publics perception of scientific facts behind food safety management, the NIFDS developed and provided risk communication contents in various format, including hazardous material handbook, smartphone application and theatrical plays. Furthermore, these contents were used to strengthen risk communication capabilities of laborers directly involved in food safety, and utilized as
3. Performances of 2010
The NIFDS performed 134 risk assessments for pesticide residues from food, food additives (tar color), heavy metals found in wine (lead, cadmium and the etc.), microorganisms (Staphylococcus aureus etc.) from marine products, nickel, aluminium, methylmercury and others from cosmetics. The NIFDS suggested provisional tolerable weekly intake (PTWI) and arranged a data integration program (MIMS) for hazardous material monitoring data of domestic food for risk assessment. The institute provided a casebook on food safety management from the regulatory agency of foreign countries such as USA, Japan and EU to support preventive safety management.
part of customized communication with specific groups. Risk Assessment Expertise Training was held twice in 2010 to exchange risk assessment techniques and foster experts by applying theories and practical trainings. The 1st training targeted officers from food and pharmaceutical sectors that were involved in risk assessment, and discussed Method to Select Optimal NOAEL of Hazardous Substance (I). The 2nd training targeted public officers and researchers from the Korea Food and Drug Administration (KFDA), and public health sector organizations established in various cities and provinces, respectively. The main subject of the training was Exposure Assessment for Hazardous Substances in Food . The NIFDS signed MOU with the German Federal Institute for Risk Assessment (BfR), a European agency specialized in risk assessment, to exchange information on integrated risk assessment, expertise, and to cooperate in relevant technologies. The NIFDS hosted an international symposium with a discussion on Present and Future
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Conditions on Risk Assessment for Food and Policy of Korea and Europe, to exchange and increase understanding of risk assessment techniques and its processes developed in various agencies.
BfR : Bundesinstitut fr Risikobewertung (Federal Institute for Risk Assessment)
foreign origin, and finally, establish a library of the reference food. In addition, the NIFDS will prepare a section on its homepage to upload domestic and foreign risk assessment information, aiming to promote the publics understanding of risk assessment procedures, evaluation and management. The NIFDS will develop and distribute different guidebooks on food poisoning prevention, preservatives and antioxidants, illegal substance analysis, food hygiene monitoring, and methicillinresistant Staphylococcus aureus (MRSA) in food and its hazard analysis. It is also to publish customized training manual for endocrine disrupter, and training material for cooking and general equipment washing methods.
The NIFDS hosted the Technical Workshop for Food Safety Risk Assessment in AsiaPacific Region with the subject on Combination of Methods for Risk Assessment, to strengthen the shared system for hazardous material safety management between Korea, China, and Japan. Likewise, it hosted an open forum on endocrine disrupters such as phthalate, for the purpose of providing accurate information and strengthening risk communication by education and training. Government agencies (the KFDA and the Ministry of Environment), NGO, and academic researchers participated in the open forum, and debated management practices to reduce the level of endocrine disrupter and to alleviate related anxieties and concerns. Developed countries are actively taking leading roles in conducting risk assessment for genotoxic carcinogens in food, such as PHA or aflatoxin. With a reference to relevant guidelines published by WHO and EFSA, the NIFDS prepared a guideline for risk assessment of genotoxic carcinogens. Moreover, another guideline for practical methods and processes required in risk assessment of specific hazardous factors in food, cosmetic and herb was published to enhance the reliability and efficiency of assessment results.
5. Expected Result
All practices of the NIFDS will facilitate the attainment of practical, fast and accurate risk assessment system by introducing steps for standardized risk assessment of each area and basis for scientific risk assessment. The NIFDS will continue to improve and protect the quality of public health, and promote national competitiveness by establishing policies that are based on risk assessment.
4. Action Plans for 2011

The NIFDS is planning to conduct risk assessments for pesticide residues in food, pollutants, microorganisms, food additives and cosmetics. It is also planning to assess emergency cases relating to food illness for validation of appropriate standards and requirements. Plans are made to collect primary data for pesticide residues, heavy metals and food additives, inspect norovirus pollution in water for human consumption, prepare research foundation to conduct an investigation on possible hazardous nutrients with the collaboration with local governments. It is also to secure DB of naturally-derived food additives and the human body monitoring data for hazardous materials, collect information on illegal and adulterated food from domestic and
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focus was made on the development and operation of the management system for quality assurance documents to address such need. The NIFDS established a system, which unifies standard work protocol forms, manages new entries, amends and
02
Enhancement of Status as an International Institute for Test Analysis and Research
compiles and history of documents, to prepare a professional and reliable operating platform. This enabled comprehensive management and efficient data search of quality documents on test analysis. Figure 7-2-1 M anagement Program of Documents on the Quality Assurance of Test Analysis
1. Overview
In order to obtain accurate test analysis results, there needs to be a system that can establish reliable detection techniques and testing procedures. For that purpose, the following procedures must be met followed guarantee the condition of test analysis. Assure quality of reference standards through strengthened management system for national reference standard that can be utilized as a reference standard during test analysis; Validate relevant facilities and equipments, and document and verify the result; Systematize the quality evaluation method of test analysis and instructions for facilities and equipments; and Document all steps of test analysis as a Standard Operating Procedure (SOP). Based on earlier objectives, the NIFDS established a system for continuous management of documents, verification of equipments, development and improvement of reference standard and method standardization, maintenance of international certification and preparation of crisis-response manual, meanwhile attaining the institutes international credibility.
3. Production and Provision of Reference Standard

Reference standard manufactured and distributed by the NIFDS are difficult to purchase from the market, and is only for use in the specialized field. Main types of reference standards are narcotics, biopharmaceuticals and herbal medicines. To 2010, a total of 36 types of national reference standards were developed and distributed. Currently, the NIFDS is also managing and distributing 43 types of narcotics, 89 types of RMPM (reference of medicinal plant materials), and 46 types of CRS (chemical reference standards). Detailed information on reference standards is available from the KFDAs website. (http://www.kfda.go.kr)
2. Development of Document Management System for Quality Assurance of Test Analysis

When the NIFDS was established as an institute for test analysis, the need to integrate scattered works on quality assurance of test analysis was raised. Primary
4. Enhancement and Development of Test

Based on socio-environmental changes, newly established standards and specifications, changes in analytical techniques with scientific advancements and preparation of administrative support for safety management, development of new
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test analysis methods and standardization are being requested. The NIFDS developed and enhanced 183 test methods through continuous efforts and hosted training on the theory and practice in the distribution of standardized tests for the 52nd time. The training demonstrated the institutes reliability and professionalism. By preparing Emergency Manual for National Lot Release for effective response against emergencies caused by new endemics, the NIFDS developed testing methods that address public requirements and rearranged its system. The NIFDS verified the superiority of human breast cancer cell proliferation test method through an international joint validation study with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), for the purpose of validating search-test method for endocrine disrupter. Also by organizing practical workshop with OECD Endocrine Disrupter search-test method to share relevant technologies and train human resources, the NIFDS confirmed its ability to respond towards any global policy management.
1. B uilding Advanced Foundation for Scientific Risk Assessment Enhancement of Status as an International Institute for Test Analysis and Research 2. 3. P roviding Scientific Basis for Advanced License Screen System and Safety Management 4. I mprovement of Status of the Institute as an International Safety Evaluation Institution through the Enhancement of Safety Evaluation Technique 5. Upgrading National Prestige through Enhancing International Cooperation
03
Providing Scientic Basis for Advanced License Screen System and Safety Management
1. Study on the Safety Management of Pharmaceuticals

1) Overview
The publics awareness in safe medicine based on social, cultural and environmental changes, internationalization of pharmaceutical approval, evaluation and safety management between developed countries and ICH, and in the dissemination of
5. Construction of an Advanced Core Laboratory

With the relocation to Osong, the NIFDS established a supporting system by constructing an advanced core laboratory for the inspection of hazardous materials, such as asbestos. The advanced safety management system was also prepared for immediate analysis of new, illegal and hazardous substances found in food and medicines. To facilitate above, the NIFDS prepared a solid hardware system by acquiring 97 equipments in 15 different laboratories, and preparing mechanisms to maintain constant temperatures and humidity, for advanced analysis of different hazardous substances. Furthermore, laboratories operate an equipment reservation system to promote task efficiency.
information through the internet are increasing. Hence the public expectation towards responsibility of the KFDA in managing, approving, evaluating pharmaceutical products and promoting their safe use, has been growing steadily accordingly. The KFDA has been reviewing Study for Safety Management of Medicine since 2004 to achieve further development and internationalization for safety management scheme, evaluation, and general management system of drugs. Moreover, the NIFDS supports the supply of safe and high quality pharmaceuticals to the people by conducting out researches and developments to lay a scientific basis of safety management policy for drugs. The purpose of these examinations is to secure transparency, objectivity, fairness of pharmaceutical approval and evaluation processes. Furthermore, they aim to promote safe and correct use of pharmaceuticals. Major research topics in Study on the Safety Management of Pharmaceuticals of 2010 includes studies on standard, specification and quality assessments, safety and efficacy assessments, equivalence, enhancement of pharmaceutical management, evaluation and assessment, and methods to reinforce monitoring of adverse effects of pharmaceuticals.
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2) Major Achievements
(1) E nhancement of Pharmaceutical Standard, Specification and Testing Methods
Enhancement of Pharmaceutical Standard and Specification The NIFDS conducted comparative reviews on international standards on additives, active pharmaceutical ingredients and final pharmaceutical products to address its need in specification enhancement measures to achieve anticipative risk prevention of pharmaceuticals. In Korea, pharmaceuticals that are primarily or frequently used are managed according to the KFDA notifications such as The Korean Pharmacopoeia and The Korean Pharmaceutical Codex. The NIFDS compared and reviewed domestic standards and test items against advanced pharmacopoeia from foreign countries such as USA, Japan and Europe. In 2010, the NIFDS established new and revised existing test items with risk concerns and thereby developed 144 amendments (proposed). Enhancement of Test Although there are test methods described in notifications such as the Korean Pharmacopoeia, international harmonization and enhancements are continuously required by considering developments in analysis techniques, industrial condition, and level of science. The NIFDS consolidated testing methods and pushed for advances in testing methods of related compounds, simultaneous analysis of combined products, sterile test from general testing methods, microbial limit tests, and residual solvent tests. These were also included in notifications such as The Korean Pharmacopoeia, The Korean Pharmaceutical Codex and The General Test Method of the Korean Pharmacopeia.
Table 7-3-1 Target and Schedule of Enhancement of Test for Drugs

Classification the Korean Phamacopoeia Standard of drugs excluding the Korean Pharmacopoeia General test excluding the Korean Phamacopoeia Current 1,565 1,538 3 test for target of improvement 90 35 1 Schedule 2010 74 24 1 2011 15 10 2012 1 1 -
Supporting Lot Release Test for Pharmaceuticals, Designation of Testing Laboratory, and their Inspections In 2010, the NIFDS examined 27 lot release testing against pharmaceuticals available in the market to verify their quality and safety. Likewise, the NIFDS also designated 5 laboratories to carry out consigned work for quality testing and conducted regular inspections.
(2) P roposed a Guideline for Pharmaceutical Approval and Evaluation, and Related Policies
The NIFDS reviewed and compared related regulations and literatures from both domestic and international sources, gathered expert views of the industry and academics, developed approximately 20 improvement proposals and evaluation guidelines for each screening assignment. These reports were forwarded to departments responsible for policy development to ensure transparency, objectivity, and fairness of drug license screening, and to harmonize with international standards. These improvements are expected to improve the understanding of new or existing drug development by pharmaceutical companies and regulatory officers, and generate positive effects such cost and time reduction for drug development, more systemized and scientific development process, and more effective drug evaluation by the KFDA officials.
(3) Provision of Customized Safety Information to Consumers

The NIFDS opened a website that delivers information on drugs in accordance with the level of customers; consumer (1st level customer), industries (2nd level customer),
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and medical specialist (3rd level customer). This established safer and more adequate control over drugs through bi-directional communication between customers and the information provider, the NIFDS. Update on the on-line Information Page on Drug Intake (http://medication.kfda. go.kr) The NIFDS created and provided video guides on proper drug intake method for different drug types, facts on drug intake for patients with liver or kidney disorders, facts on drug interactions, and method to read fact sheet included in medicines. Also, information on Over-The-Counter (OTC) is available in both Vietnamese and Chinese languages. Update on the Information Page with Reference to the Usage of Drugs (http:// opendrug.kfda.go.kr/drugsafeuse) The NIFDS uploaded materials to provide additional information on therapeutic effect and safety for frequently or commonly prescribed anti-fever/anti-inflammatory, antibiotic, cardiovascular and metabolic drug. Formation of a Database for Bioequivalence Test Data (for Project Plannings and Reports) and Update of the Elution Comparison Test Data on the KiFDA Web Site for Examiners The NIFDS formulated a database, enabling 20,819 bioequivalence test data to be searched for the KiFDA website, where the information can be accessed for future project design or reports.
3) Future Projects
(1) A dvanced Prevention Management through the Enhancement of Standard, Specification, and Test Methods of Pharmaceuticals
The NIFDS will analyze trends in drug standards and its international harmony by monitoring other countries, and regularly examining the enhancement in the drug standardization. The institute will fully support the protection of the national health care through the advanced prevention management, and be involved in resolving any public anxiety or concern over pharmaceuticals and their safety. The NIFDS will also prepare phase-based amendment (proposed) of testing methods that require revisions by 2012, through organizing various research projects.
(2) Guidelines for License Screening of Drugs, and Political Plan

In 2011, the NIFDS will prepare 16 amendments (proposed) to improve pharmaceutical approval and evaluation scheme, and develop and provide assessment guideline for each evaluation departments, as part of initiatives to promote pharmaceutical approval and evaluation procedures that conform to the international standard.
(3) P roviding Safety Information on Drugs for the Socially Vulnerable Groups
It is a world-wide tendency to establish a safety-net for socially vulnerable groups. Also, the importance of preparing safety measure, while addressing the distinctive nature of each group, is being equally highlighted. The NIFDS will present revisions of related regulations, such as the introduction of pictograms, to enhance the integration of drug intakes in elderly, publish and distribute books with Braille and voice code for the visually-impaired, and booklets translated into different languages for multicultural families, to help improve their quality of life (proposed).
(4) R esearch for the Enhancement of Good Manufacturing Process (GMP) for Pharmaceuticals
The NIFDS organized an international training of WHO (World Health Organization)/ GLO GMP for 10 GMP inspectors from 7 different countries including the Philippines, Laos and Cambodia, for 9 days from March 9 to March 17, 2010. The institute also completed an English translation for Implementing Regulations of Pharmaceutical Affairs Law (Table 3), Quality Management Standard for Biological Products, and GMP related regulations, as a preparation for acquiring the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) membership.
(4) Providing Consumer Customized Safety Information

The Information on Safe Use of Medicine provides customized safety usage information to patients who are affected by high risk diseases, and medical experts, such as doctors and pharmacist. It demonstrates the safe use of drugs for respiratory,
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alimentary, and urogenital systems, and for allergy, antifungal, and anti-viruses. It is expected to provide information on safe and efficient use of drugs. It can also be referred during safety management actions invoked by adverse effect event for the analysis of cause-and-effect relationship.
(1) Establishment of Tests for the Quality Management of Biopharmaceutical Product and Establishment/Revision of Related Regulations
For the improvement of biopharmaceutical national lot release testing, the NIFDS established quality management testing methods and prepared effective management system through newly establishing or revising related policies. In addition, a recording scheme of The Korean Pharmacopoeia for recombination medicine (interferon) has been arranged to provide the local industries with more accessible and effective in quality management that conforms to international standards.
(5) Research for the Enhancement of GMP of Pharmaceuticals

The NIFDS will monitor training system for pharmaceutical GMP inspectors in US, Europe, Japan and other countries and recommend appropriate training directions for local inspectors. There is a plan to translate GMP related guidelines and SOPs, and conduct researches to develop and install QbD/PAT foundation for pharmaceutical manufacturing and quality assurances.
(6) E stablishment of Side Effects Management System of Drugs in Accordance with International Standards
The NIFDS is to build localized drug monitoring centers in 20 different locations by 2011.
(2) D evelopment of Guidelines (Proposal) for the Evaluation of Biological Drugs

The NIFDS undertook researches to provide evaluation guidelines for each biological drug derivative and developed/published 6 guidelines (proposed) such as Guide for Management of Cytoplasmic Matrix Utilized for Manufacturing of Biological Drugs.
2. Research on the Safety Management of Biological Drugs

1) Overview
The KFDA has been conducting researches to establish a basis for the evaluation on the standard and safety management of biological drugs such as vaccine, blood products, gene recombination drugs, drugs used in gene therapy, cell therapy derivatives, and biological diagnostic derivatives. The main research areas are Safety management of biological products Evaluation of vaccine viability Safety management of advanced therapy products, and Cooperation with international organizations.
(3) D evelopment and Implementation of Internal and External Training Programs for Pharmaceutical Approval and Evaluation Procedure
To address the latest trends of the rapidly changing biological drug and increase efficiency in collecting relevant data, the NIFDS organized the Biological Medicine Examiner Course as a regulator training program.
(4) Production and Establishment of National Reference Standard

The KFDA started manufacturing and distributing national reference standards of biological drugs since 1998, and produced, managed and distributed 36 products to present. Moreover, the KFDA conducts stability monitoring for national reference standards once a year to improve the reliability on their quality. As an example of such monitoring, the KFDA built separate storages.
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3) Future Plans
(1) F ormulation of Newly Standardized Local Products and Continuous Improvement of the Management System
In 2011, projects to establish national reference standards for nine blood coagulation factors and anti-tetanus human immunoglobulin will continue. Also, there will be continuous improvement in operating national reference standard development.
3. Study on the Safety Management of Herbal Medicines

Herbal medicines are natural materials that contain numerous substances and differs from chemical drugs, which contains single ingredient. Its quality is not uniform due its content of an active ingredient, which may vary according to cultivated area, geographical condition, climate, cultivation period, drying method, and storage method. Nonetheless, the assurance of uniform quality is crucial as it determines the safety and efficiency of a drug. Therefore, it is crucial to manage uniform quality by establishing appropriate standards. Korea has used herbal medicines traditionally and recorded a total of 563 items of herbal medicine. Of these, 181 items can be found in The Korean Pharmacopoeia, and 382 items in The Korean Herbal Pharmacopoeia. The Korean Pharmacopoeia, The Korean Herbal Pharmacopoeia and Korean Pharmaceutical Codexare being revised annually by applying the most recent scientific standards and test methods for reasonable and scientific management of pharmaceutical products. Furthermore, Herbal Medicinal Products Division manages Herbal Resource Centers at Okcheon of Chungcheongbuk-Do, Yanggu at Kangwon-Do, and Jejudo. They collect and preserve herbal resources with distinct origin and provide information on herbal medicines. All information on herbal medicine are being provided through General Information System of Herb Medicine (http://herbmed.kfda.go.kr), and pictures, origin, features and conditions, related study data (study reports and guidelines) are constantly being updated. The site also provides information on the use and interaction of herbal medicine and its accessibility to ordinary citizens.
(2) Formulation of a Standard for the Evaluation of Biological Drugs

The NIFDS will produce a detection method for hazardous substancs in vaccines and blood products through basic research for the valid evaluation of clinical trial data on newly introduced vaccines, and establish medium and long term plans for safety/ efficacy assurance of distributed vaccine. It will also evaluate virus validation, research for management of blood plasma used to produce blood plasma fractionated products, and research for the detection of harmful viruses found in blood.
(3) Formulation of a Standard for Recombination of Drugs

The NIFDS will start to constitute an internationally harmonized standard for interferon assays to support the development and quality management of industries for the drug recombination, including biosimilar product development. This will extend out to establishing related standards for EPO, somatropin and other substances.
(4) D evelopment of Assessment Techniques and Standards for Biopharmaceutical Products

The NIFDS establish assessment techniques for assured quality, safety and efficacy of biopharmaceutical products and introduce systemic guideline to establish fair and transparent approval processes. Furthermore, the institute is aiming to develop effective approval and management systems to provide supports in developing drug products.
4. Study on the Safety Management for Cosmetics and Quasidrugs

The purpose of this study is to assist the improvement of the national health care and the competitiveness of the national industry by developing standards and test methods to extract harmful substances in cosmetics and quasi-drugs that are closely associated with the daily lives of the public. It aims to provide safety information to the public for their assurance, and to allow the industry to conduct advanced risk
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management based on science. The NIFDS provided relevant departments with The Standards and Test for Nonmedical Products, revised (proposed) Regulations for Setting Raw Materials of Cosmetics and Amendments/New Standards for raw material and their specification for Quasi-drugs. These documents were produced by inspecting and conducting comparative studies with international specifications. They also aim to ensure specifications of cosmetics and quasi-drugs are in line with international specifications. The NIFDS developed advanced tests for hazardous substances for cosmetics and quasi-drugs closely related to daily lives of the public, where these substances may lack specific analytical method and possible cause issues and concerns. The NIFDS also performed quality tests on products already available on the market, which were collected to confirm their safety. The NIFDS is currently establishing a scientific foundation for safety management policies, based on a fast and accurate analysis and scientific risk assessment of hazardous substances, such as steroids, as safety issues of cosmetic products are becoming more frequent. The institute also designates institutions to conduct quality test of cosmetics or quasi-drugs, and assist the further research on actual cases. The demands to secure safety of daily household items, such as cosmetics, are increasing due to the peoples awareness on hazardous substances and knowing the different ways to protect them. The NIFDS helped educate people on cosmetic risk assessments for through the circulation of Information Newsletter on Food and Drugs and distribution of brochures. Furthermore, it provided Safety Information Service on Cosmetics to enhance the accessibility of fast and accurate data to consumers and related industries. In the future, the NIFDS is to revise standards (proposed) for items recorded on existing regulations, support approval, evaluate safety management of cosmetics and quasi-drugs through by establishing corresponding analysis method, and create a scientific risk assessment system to act actively against safety incidents or accidents of cosmetics and quasi-drugs.
5. Study on the Safety Management of Medical Devices

1) Overview
The development of medical devices along with new technology is advancing due to the aging population and well-being becoming a cultural trend, general improvement of quality of life, also with the appointment of medical devices as one of the future growth engines. Therefore, establishing an evaluation system for medical devices is essential to ensure their safety and efficacy. Additionally, the formation of GMP, international harmony, and securing of international reliability of medical equipment are becoming significant. Lastly, studies on evaluation methods for safety and performance of high-tech fusion medical devices, newly developed with support for high-tech medical equipment and fusion technology are required. Studies on the enhancement of the safety management of medical radiation directly transferred to patients must be examined.
(1) Enhancement of Standards of Medical Devices
The KFDA is conducting studies to enhance standards for all type of medical devices. They began working on the enhancement of medical equipment standards in 2009, and accomplished 77% of the total workload. They revised of 7 chapters on The Common Standards for Biological Safety of Medical Equipment, which includes revisions for whole body toxins and transplant tests.
(2) F ormulation of a Basis for Evaluation Technique of New Medical Devices Technology and Radiation Safety Management through the Provision of Guidelines for Medical Devices Evaluation, and Manuals
The NIFDS improved the standardization, scientific approach, and internationalization of screening for technical documents of medical devices through publishing guidelines for major medical devices and new-tech equipments. A guide for formulating technical documents to improve local quality management and international competitiveness
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of medical devices was also published. Likewise, they published journals of guidelines on the recommended amounts of radiation for patients and an individual, to reduce patients and health industry laborers exposure to radiation.
reviewed for the general management and real condition of management within it.
(8) I mplementation of Policies for the Enhancement of GMP of Medical Devices

The NIFDS analyzed fee schedule of major GMP inspection authorities in both oversea and local locations to set a reasonable medical device GMP inspection fee. Moreover, they suggested a precise and efficient system, structure, and requirement for the implementation of post-sale monitoring through the formation of operation standard and guidelines of research on the actual condition for foreign producers of medical devices.
(3) Development of Evaluation Technique for High-tech Medical Equipment

The technical development in the improvement of accessibility to medical conditions with remote medical treatment using Ubiquitous-healthcare medical devices is prolonged due to the widespread use of smart phones, tablet PCs and other similar devices. Developments of better security, interactive working and evaluation technique according to each function of U-healthcare medical devices is currently in progress.
(4) Maintenance/Supply of Standards for Medical Radiation

The KFDA established a quality system that conforms to KS Q ISO/IEC 17025 standard, and has been designated by the Korea Laboratory Accreditation Scheme (KOLAS) as a calibration agency. It also maintains and supplies standards for medical radiation.
3) Future Plans
The NIFDS will develop a new technique for the safety evaluation of newly introduced medical devices and new growth engine industries based on the development of scientific technology. The institute will regularly develop and implement standards for various medical equipments. In addition, it will prepare an integrated management system for external diagnostic products, which are currently being managed separately as medicine and medical devices domestically, and publish manuals and check-list for long-term enhancement of GMP. Finally, it will develop and secure an evaluation technique of radiation for safety management in treatment and diagnostic fields, and publish guidelines by regularly providing relevant information.
(5) Safety Management on Medical Radiation Producing Equipments

In March 2010, there were 65,313 diagnostic radiation equipments installed in medical institutions around the country. The equipments and radioactive protected facilities were inspected 27867 and 7910 times in 2010, respectively. There were 376 incongruous equipments present which account to only 1.35% of the total equipments.
(6) Assurance for the Amount of Radiation in Medical Care

The KFDA has projects to manage radiation level used during medical care in local medical institutions, and enhance and maintain their accuracy to the level of international standard.
6. Customized Support from Initial R&D Design to Final Drug Approval

1) Overview
In general, pharmaceuticals are going through various types of rigorous scientific assessments regarding their quality, toxicity, pharmacology and clinical trials prior to receiving marketing approval. The Center for Drug Development Assistance (CDDA) is tasked to provide expert
(7) T esting of Medical Device Quality Management and Supporting Inspections of Testing Institutions
The testing of medical device secured the reliability and fairness on test results through the establishment of scientific and advanced test methods. The KFDA performed technical support for the designation of test institution and evaluated/
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consultations on regulatory issues ranging from the initial drug development stage through final approval processes, and provide clients with opportunities to receive the necessary training regarding regulatory matters related to drug approval.
(4) Visiting Service for Domestic Drug Developers

The CDDA visited 11 institutions in 2010, including universities, research labs and venture companies, to offer training and consultations on approval-related processes and requirements.
(1) Technical Consultation

The CDDA provides technical consultations on various drug-related regulatory issues ranging from R&D design, clinical trials, approval and post-approval control. The types of drugs offered for consultation are chemical drugs, biological drugs, herbal medicines and quasi-drugs. The number of consultations offered in 2010 4774 in total, which was 25% higher when compared to the previous year. Out of the 4,774 cases, consultation on incrementally modified drugs was the majority accounting for 44% followed by generic drugs and new molecular entity. By indication-related consultation, metabolic medicines such as drugs for diabetes or osteoporosis came first at 12% followed by central nervous system drugs including medicines for dementia and arthritis and medicines acting on the circulatory system such as high blood pressure medicines. The results show that pharmaceutical companies are exhibiting an increasing interest in developing drugs for senior citizens as the number of elderly patients is on the constant rise.
(5) Cooperative Network

The CDDA is operating a drug development support unit to provide expert advices and support for governments R&D projects to develop new drugs. The CDDA is currently working with the Ministry of Knowledge Economy, Ministry of Health and Welfare and Ministry of Education, Science and Technology to provide technical advices for their R&D projects.
(2) CDDA Publications

The CDDA published Guidance on Successful New Drug Application in November 2010, to give information on drug development processes and data submission requirements for obtaining approval. In addition, the Center published Informational Magazines four times a year. This quarterly-published magazine contains articles on success stories of drug development, clinical trial approval status and information on overseas approval-related regulations.
(3) Training Workshops

The CDDA has so far hosted four training workshops to provide local drug developers with opportunities to learn detailed information on regulation, pharmaceutical quality, non-clinical and clinical.
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1. Building Advanced Foundation for Scientific Risk Assessment 2. Enhancement of Status as an International Institute for Test Analysis and Research 3. Providing Scientific Basis for Advanced License Screen System and Safety Management 4. I mprovement of Status of the Institute as an International Safety Evaluation Institution through the Enhancement of Safety Evaluation Technique 5. Upgrading National Prestige through Enhancing International Cooperation
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on 5 herbal medicines; moutan, Chelidonium majus, Cimicifuga rhizome, Xanthium
strumarium and Hovenia dulcis .
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mprovement of Status of the Institute as an I International Safety Evaluation Institution through the Enhancement of Safety Evaluation Technique
(2) Development of Test Methods and Evaluation Technique

The NIFDS conducted repetitive toxicity test and geno-toxicity test on 3 herbal medicines, such as mahuang, for 13 weeks. For that, the institute secured the raw material of cinnamon extracts, and conducted substance analysis tests, repetitive administration test for 14 days to determine dosage and gene toxicity tests. The result was subsequently submitted for the preparation of safety evaluation and management actions and the production of toxicity data for herbal medicines, as a post measure to signing MOU with US NTP.
1. National Toxicology Program in Korea (KNTP)

1) Overview
Although the publics awareness on safety and function of foods and drugs are increasing, the possibility of risks posed to human health due to the appearance of hazardous substances is also on the rise. These substances, such as hazardous chemicals, heavy metal contamination, and exploitation of organic materials are posing a threat to public health care. According to demand, the NIFDS is operating National Toxicology Program in Korea (KNTP) to support the enhancement of national health. They perform toxicity tests on selected hazardous substances, which directly concerns national health.
(3) Examination of Toxicity Test

The NIFDS examined repetitive toxicity test of 13 weeks on 3 herbal medicine such as mahuang, genetic toxicity test, and securing-analysis of raw materials of cinnamon extracts for these tests, repetitive decision making test for capacity and genetic toxicity test for 14 days to provide scientific basis for building toxicity test data of herbal medicine as a post-action for American NTP MOU, and for safety evaluation and establishment of management system on herbal medicine.
(4) Review of Basis and Application for Toxicity

The NIFDS performed a peer review on the KNTP toxicity test data, and cross checked it with pathology data to improve their reliability. Further investigation and research have also been made for toxicity, poisoning and product information required to build toxicity information database, and reinforced it accordingly.
2) Advancement of KNTP in 2010

(1) Establishment of Toxicity Infrastructure
The NIFDS formed the basis and a network for international cooperation on KNTP, supported technical aspects of KNTP toxicity test, improved expertise of scientists in related field (conducted toxicity pathology internship training program). It also established an electronic program on KNTP toxicity testing, where it won a bronze award from Korean Software Contest. It also operates KNTP management and advisory committees, collects and analyses relevant information from foreign NTP and international organizations such as OECD, and updates new information to current KNTP database. Lastly, it produced technical reports and peer-reviewed documents
2. Establishment of Toxicity Information Database

1) Overview
The NIFDS began the establishment of toxicity information DB for quick search of toxicity information on food and drugs in 2006. Poison information DB was added in
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2007 and product information DB in 2008, to support the professional treatment of poisoning in regional areas. The current toxicity information system, known as ToxInfo, merged all three systems mentioned above into one database.
2) Major Achievements of 2010

R esearch conducted to establish a basis to build a nano-materials safety support center The NIFDS supported collaboration researches, based on suggested 14 main nano-materials selected by OECD WPMN. The institute also secured differential data on target organs and blood through in vivo safety test for nano-materials from gold. It also trained specialists in the field of nano safety. S tudy on the safety evaluation of nano-materials OECD suggested a list of nano-materials that can be used as raw materials for nano-feed. The NIFDS selected 5 types of nano-materials and performed safety evaluation to deduce lethal dosage level. Study on the basis of evaluation for nano-food The NIFDS established conditions for the production and analysis of protein and mineral nano-calcium from food according to their size, and compared and studied their accumulation and distribution in the human body by size and volume. The institute also suggested in vitro and in vivo protocol (proposed) to evaluate the movement of nano-food in the human body. Department of study on the basis of nano safety evaluation. The department performed a study on the effect and movement of toxin according to administration method, and developed analysis techniques within and out of the human body for a nano-materal called ZnO. ZnO was selected from 14 nanomaterials suggested by the OECD WPMN.
2) Major Achievement of 2010

Toxicity data DB (Tox-Info) provides toxicity, metabolic, dynamic and general information of substances that are potentially harmful to humans in Korean. It provides the poison information DB containing clinical toxicity data (clinical aspects, diagnosis, emergency measures, de-toxicant, etc.) required to treat poisoned patients, and products information DB containing information of products that carry poisonous substances. The institute also published booklets on the prevention of accidental poisoning in children, also organized trainings.
3) Major Plans for 2011 and Medium-Long Term Growth Plan

The NIFDS will actively promote poison information required for proper treatment that can quickly treat patients of poisoning, and product information on products that contain poisonous substances for the treatment and prevention of accidental poisoning. Information materials are added on a regular basis and are submitted to the local medical emergency system, such as central emergency medical centers.
3. Study on the Basis of Toxicity from Nano-materials

1) Overview
The NIFDS is performing development of safety evaluation technique of nanomaterials, which is currently being developed actively worldwide. They will assist in the improvement of national health care through safety evaluation of nano-products in foods and drugs.
4. Study on the Basis of Evaluation Technique for Toxicity

1) Overview
The study on the basis of evaluation technique for toxicity aims to establish a reliable and competitive local basis for toxicity studies compared with international standards through the development of technique for the prediction and evaluation on toxicity, and to secure toxicity evaluation system.
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2) A nnual Examinations on the Basis of Evaluation Technique for Toxicity

The contents of annual examinations of the study on the basis of evaluation technique for toxicity are listed below. Table 7-4-1 C ontents of the Performances of the Study on Basis of Evaluation Technique for Toxicity
Aim and contents of business Study on local validation for establishment of toxicity evaluation standard - Study on genetic toxicity evaluation for international harmony of safety evaluation for medicine - Organization of terms on abnormal embryo-fetus and publishing of source book - Study on local validation about in vitro/in vivo comet assay Study on alternative animal test for international harmony and approval - Establishment of non radioactivity test for part of lymphatic gland according to OECD guideline Performances - Test for skin irritation using improved artificial skin model of - Search for additional indicator for test of mucous membrane of eye using cornea of cow 2010 - Laboratory validation of non radioactivity test for part of lymphatic gland using analysis of parenchyma cell Study on next generation in regards to hazardous substances exposure during pregnancy - Study on development of biological indicator about alcohol spectrum disorder in fetus - Study on effect of folic acid related genetic variation for future generations - Study on effect for development of immunity of fetus caused by exposure of hazardous substances Research on alternative animal test - Research on alternative skin autosensitization test using cell strain from human body and mouse - Research on alternative skin autosensitization test through peptide reactivity test - Development of alternative light autosensitization test using analysis of parenchyma cell - Research on alternative light autosensitization test using cell strain Plan for 2011 Research on enhancement of standard documents about process for special toxicity test - Establishment of standard documents about process of heredity, reproduction, immunity toxicity test Research on establishment of guideline(proposal) for evaluation of non clinical trial in order to harmonize regulations on medicine - Establishment of guideline(proposal) of screening and revision(proposal) of related regulations for approval of clinical trial plan and products - Establishment of guideline(proposal) of evaluation for immunity toxicity of medicine, and etc. and revision(proposal) of related regulations
5. Study on the Prognosis of Safety on Drugs

1) Study on the Prognosis of Safety Using Toxic Gene Technology
The NIFDS is conducting various projects on a development of safety prognosis technique based on gene, determination of toxic marker in a living body, and research of toxicity production using bioinformatics.
(1) S tudy on the Development of Safety Prognosis System in Pharmaceuticals

The NIFDS is examining the development of the system that can predict drug toxicity, using hepatic cells from humans, rats and OMICs technology. In addition, a cooperative study with the American FDA National Center for Toxicological Research (NCTR) is being conducted to establish LTKB (Liver Toxicity Knowledge Base) through securing profiles of transcriptome, protein, and metabolome for 200 substances that cause liver toxicity.
(2) S tudy on the Identification of Toxicity Indicator for Living Body Using Biological Information Science
The NIFDS is to develop LiverToxPredictor program, which can identify both known and unknown liver toxins and their interrelations, and toxicity prediction indicators. This program will be provided to the KOTIS database (http://kotis.NIFDS.go.kr).
2) Pharmacosafety Research
The NIFDS developed various types of training resources, such as the guide and leaflets on testing procedures for pharmaco-safety, to support new drug developers. It also hosted the 12th Pharmacology Research and Pharmacosafety Seminiar, to play a leading role in the exchange of relevant technologies in this field.
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3) Dependence Study
The NIFDS performed evaluation tests for dependence and examination propofol and its abuse, to provided clear scientific basis in defining it as a psychotropic drug for the first time in the world. The institute also published and distributed a pamphlet titled Beware the use of Propofol!, and produced the 8th Scientific Information paper on Drug (SIDA) containing an article on propofol to prevent its abuse.
conditions for drug usages for Koreans are particularly relevant. Department of clinical study of NIFDS, which hosted a symposium for leading researcher consultative group of pharmacogenomics, is developing a diagnostic kit for Korean pharmacogenomic type and currently possess 11 patents for various pharmacogenomic types. The institute also maintains a Korean pharmacogenomic information DB on the NIFDS website. It established a basis of development and evaluation for personalized drugs appropriate to the Korean pharmacogenomic type. In 2010, this study was selected as one of the 100 leading national researches and development programs.
4) Study on Drug Metabolism

The NIFDS runs a research group to study drug metabolism. This group is primarily responsible for the development of standard enzyme based on enterobacteria complex found in Koreans, analysis and identification of a metabolome, and research to find interrelation between rumen microorganism and eating habits or disease. The NIFDS planned and performed a series of promotion such as Understanding of Enterobacteria in Everyday Life based on study results of the research group, which helped to raise the awareness of the public on these microorganisms and their role in the publics daily lives.
2) Study on the Establishment of an Evaluation Basis on Clinical Trials for Korean Population
A clinical trial is a test or research performed on humans to identify movement, history, action, clinical effect of a drug. The trial also investigates abnormal reactions of the drug to confirm their safety and efficacy of a drug. In a development process, a clinical trial is a highly significant step in deciding the effectiveness, and usage-volume of medicine because safety management, including quality, safety and efficacy of medicine, is necessary. The department of clinical study is establishing Microdose Clinical Trial Guideline,
6. Study on Pharmacogenomic Information and Evaluation Guidelines of Clinical Trials

1) S tudy the Basis of Evaluation for Personalized Medicine Appropriate for Koreans
Pharmacogenomics is a discipline that identifies the genetic information that causes individual differences in drug reactions.. It is a leading science of personalized medicine, which can maximize the effects of treatments without the risk of causing any side effect. Pharmacogenomic differences reflect not only individual differences in drug reactions but also ethnic differences in the drugs metabolic ability. Therefore, understanding of pharmacogenomic information and establishment of appropriate
which fits domestic situation, to address the international vitalizations of microdose clinical trial, a high tech clinical trial technique that can increase the success rate in the development of a new drug. The institute has also hosted a Workshop for using Initial Stage of Clinical Trial (phase 0) in Developing New Drugs. It also established Clinical Trial Database to ensure evaluation technique of clinical trial and are preparing to upload data of nearly 1,000 clinical trials.
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7. Management and Study on Test Animal Resource

1) Management of Test Animal According to International Standards
The NIFDS registered an animal test facility according to Test Animal Act, and supported various responsibilities such as national vaccine approval, and researches with high tech facilities in international standard. They received a certification from the international certification institute for test animal (AAALAC-I) in February 2001, and are aiming to achieve a re-certification since the move to Osong in 2011. The Animal test facility of Osong Health Administration Complex is the largest facility among other similar facilities in the nation. It is composed of 4 facilities with high tech equipments. Total area of 15,541m2 includes a laboratory for test validation, a laboratory for raising and testing sterile animals, a testing laboratory for hazardous substances, and an animal testing laboratory. The facility is totally isolated from the external environment using a barrier system. The NIFDS is developing model animals that carry a disease similar to those occur in human and is providing them for domestic and international research-development of effective drug evaluation studies. The institution is likely to be assigned as a donating, registering, and conserving institution (April 1st, 2010) for a mouse, the disease model animal and resource of biological researches of national health and welfare. The institute will secure and sustain test animal resources while allowing local researchers to access these resources.
3) Establishment of a National Management System for Test Animals

The NIFDS carried out national management of test animals since 2004 to improve the management level of domestic test animals and lead an early establishment and stabilization of regulations, according to the enactment of Act on Test Animal. Through this, the institute supported the quality management of test animal being used in the safety management of food-drug in a view of microbiology and genetics, secured reliability of animal test results, developed and secured disease model animals, and distributed the animals to universities and laboratories to support drug effect evaluation and biological researches. An animal test facility manager training for builders, managers, suppliers, and examiners of animal test facilities was also organized according to Act on Test Animal.
2) Scientific Support for Animal Tests

The NIFDS runs a test animal management committee with external members, such as civilians and veterinarians, attending. The committee reviews and approves animal test plans and supervises the operation and management program of test animal in institutions. In 2010, a total of 26,027 test animals were used for national lot testing and researches. In terms of species, 2,988 mice, 326 rats, 1,852 guinea pigs, 1,827 rabbits, 37 dogs, and gerbils were used.
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through training workshops. The AHC is working continuously to provide practical and useful training programs for regulators and industry experts in the APEC region, thus contributing to bringing
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Upgrading National Prestige through Enhancing International Cooperation
growth in regional efforts to achieve regulatory harmonization of pharmaceuticals and medical devices. The AHC has so far been highly regarded for its excellent training programs. The AHC will continue to work hard to meet the training needs of the region and become an exemplary model for regulatory harmonization in the region.
1. APEC Harmonization Center

The APEC Harmonization Center (AHC) was established on June 15, 2009 within the Korea Food and Drug Administration (KFDA) following endorsement of its establishment by APEC leaders and ministers at the APEC Leaders Summit Meeting in Lima, Peru in 2008. The AHC is an official APEC training center under the APEC Life Science Innovation Forum (LSIF) dedicated to providing both regulators and industry representatives in the region with high-quality education programs with the purpose of promoting regulatory harmonization of pharmaceuticals and medical devices. The AHC organized three training workshops in 2009 with the attendance of about 1,500 participants in total. In 2010, the center hosted three international training workshops covering a wide range of topics including pharmaceutical supply chain, multi-regional clinical trials (MRCT) and medical device clinical study. In the year 2011, the AHC, with Drug Information Association (DIA) and International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), co-organized the Asia Regulatory Conference under the theme of Asias role in global drug development in April. The center hosted the medical device workshop in early July in cooperation with the Asia Harmonization Working Party (AHWP) to discuss implementation of GHTF guidelines. Additionally, the AHC, partnered with ICH, to hold the Quality by Design workshop in October to provide in-depth lectures on ICH Q8, Q9 and Q10 guidelines. In addition, the AHC has formed the Advisory Board (AB) composed of experienced experts from regulatory authorities, industry and academia around the world to seek their expert input and opinions regarding AHCs training programs. The AHC is continuously seeking to expand its AB to develop and provide quality training courses
2. International Cooperation on Alternative Animal Tests

USA, Japan, Europe, and Canada signed an International Cooperation on Alternative test (ICATM) in order to assist scientific validation and evaluation of new alternative test in April, 2009. The Korean Center for the Validation of Alternative Methods (KoCVAM), established in November 2009, have tried to create a cooperative basis with centers for the validation of alternative methods of USA, Europe, and Japan through participation of 5 meetings such as ICATM conference 2010, and scientific advisory meetings of foreign centers for the validation of alternative methods. KoCVAM allowed Korean laboratories to participate in international joint researches with USA and Japan, and tried to establish a related local infrastructure through the hosting of the international symposium and workshop on alternative tests.
3. Operation of WHO GLO Training Center in the Field of Biological Medicine

The KFDA was designated as a training center of WHO/GLO GMP in December 2007 and have undergone international training. They provided training opportunity to 43 GMP inspectors from 12 different countries such as Philippines, Thailand, Iran, and Turkey. They have, likewise, participated in clinical examiner training on vaccine, hosted by WHO since 2005, to be designated as a WHO/GLO clinical examiner training center on vaccine. They hosted the 1st expert meeting for designation as a clinical examiner training center and submitted a memorandum on the clinical trial examiner
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training on a vaccine to WHO. The KFDA underwent a clinical trial examiner training to operate WHO Global Learning Opportunities (GLO) and was authorized to become a WHO GLO clinical trial (GCP) training center. The KFDA will secure professionalism of GMP inspector, and establish a scientific and efficient approval/evaluation system by cooperating with WHO to become an international leading regulatory body.
The KFDA has performed various WHO collaborating activities such as joint research on international standard products, provision of GMP inspector training and similar works from 1998 up to the present. Table 7-5-1 Major Programs of WHO Collaborating Activities (Aug. 1998~Jul. 2011 up to the Present)
Field International joint research Main Contents Establishment of international standard of endotoxin, Establishment of international standard of BCG vaccine and etc. Training for GMP inspectors from 14 countries such as Thailand and Egypt, selected by WHO Evaluation on stability of vaccine, regulation on biological medicine and etc. WHO Assessment Guideline for biopharmaceuticals and etc. Expert meeting on WHO biopharmaceutical regulation, Network meeting on vaccine regulation, etc.. Performances 23 6 4 5 56
4. Operation of WHO Collaborating Centre for Biological Standardization

The WHO collaborating center is a network to carry out global cooperation works, authorized by the WHO secretary general. (Reference : Definition of WHO collaborating center - A WHO Collaborating Center is an institution authorized by the Director-General to form part of an international collaborative network carrying out activities in support of the Organizations programs at all levels) Just before 2010, in the field of the standardization for biological medicine, the FDA CBER of USA, NIBSC of UK, PEI of Germany, TGA of Australia, NIID of Japan were designated as WHO collaborating centers. The KFDA was authorized as the 6th WHO collaborating center in January 2011. It denotes that the KFDA was validated as an advanced institution for biological medicine. Figure 7-5-1 Signboard Hanging Ceremony of WHO Collaborating Center
Training Hosting WHO/KFDA Joint workshop Support for development of WHO guideline Participation of international meeting
The KFDA will perform technical reviews on newly established or revised WHO guidelines, international joint researches as a WHO collaborating center, and will host workshops for the application of international standards in WHO Western Pacific Regional Office (WPRO).
WHO divided and administered the entire world in 6 regions, with South Korea included within the West Pacific region
5. International Cooperation with EDQM

There are increasing demands on the international agreement on drug management. The KFDA agreed to active cooperation with the European Directorate for the Quality of Medicines & Healthcare (EDQM) and signed an MOU in October 27th, 2010 (Strausbrou, France). They performed KFDA/EDQM joint workshop as a post-MOU action in May 29th, 2011 in order to maintain and improve the agreement (Osong, Korea).
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The EDQM is a specialized institution which conducts researches that can serve as a basis of safety management such as the publishing and distribution of European Pharmacopoeia, validation of test and analysis for the contents of standard in Pharmacopoeia, management and distribution of standard products of drugs and biological drugs. They agreed to exchange information on the standard of pharmacopoeia, technical cooperation on the standard products of drugs and biological drugs, technical cooperation and exchange of information between tests and analysis laboratories (such as OMCL), mutual training of workers and hosting of the joint workshop.
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2011 KFDA Report

2011 KFDA Report

187 Osongsaengmyeong2(i)-ro, Gangoe-myeon, Cheongwon-gun, Chungcheongbuk-do, Korea 363-951 Tel : +82-1577-1255

Registration Number 11-1470000-001902-01

2011 KFDA Report

2011 KFDA Report

the Commissioner of the Korea Food and Drug Administration

Korea Food & Drug Administration

Successful Relocation of Osong Health Technology 26 02  Administration Complex

Reinforcement of Cooperation with 33 04 

Consumer Organization and Civil Affairs Administration Service

40 05 Policy Statistics to Manage Productions

KOREA FOOD & DRUG ADMINISTRATION

48 06 Korea Internet Food and Drug Administration (KiFDA)

51 07 Promotion of R&D - Supporting the Safety of the Public

Chapter 01 Scope of Policy Support

Food and Drug Risk Prevention and Dissemination of 62 01  Safety Information

Integrated Control System of Risk Information and 70 02  Reinforcement of Analysis Capability

72 03  Introduction of an Advanced Operation System in Foods

Preventive and Scientific Management Infrastructure of Food Hazards 76 01 

91 02 Securing Health by Food and Nutrition Management

119 04 Establishment and Operation of Food Safety Information Center

Chapter 02 Risk Prevention

Conditions and Prospects of Biopharmaceutical Products 194 01  Administration

Chapter 04 Pharmaceutical Products

194 199 202

203 02 System Management of Biopharmaceutical Quality Assurance

Current Status and Progress in Pharmaceutical Product Safety 152 01  Management

160 02 Promoting Appropriate and Safe Use of Pharmaceuticals

209 04 Safety Management of Human Tissue

170 03 Assistance in Commercialization of Pharmaceuticals

Establishment of Management System for Cosmetics and Sanitary 228 06  Aid

Establishment of Foundation for Supply of Safe and Effective 178 04  Pharmaceuticals

186 05 International Cooperation in Pharmaceutical Sector

Chapter 05 Risk Prevention Area

246 01 The Condition and Direction of Medical Devices Safety Control

Chapter 07 Food and Drug Safety Assessment

282 01 Building Advanced Foundation for Scientific Risk Assessment

254 02 Improvement of Medical Devices Pre-Management System

267 04 Establishment of Medical Devices Quality Management System

272 05 Strengthened Post-Management of Medical Devices

Improvement of Status of the Institute as an International 306 04 

Safety Evaluation Institution through the Enhancement of Safety Evaluation Technique

Chapter 06 Medical Device Area

Upgrading National Prestige through Enhancing 316 05  International Cooperation

365, Happier Korea

365, Happier Korea

The Top 6 Priority Tasks

2.  Tightened safety control from raw materials to consumption

3.  Support for competitive new growth engine industries

5.  Vitalization of communication to spread sympathy of safety

6.  Strengthening cooperative system to establish safety basis

Korea Food & Drug Administration

Korea Food & Drug Administration

Vision / Mission / Aim

Promising Future 2020 for a safer/healthier life for the people

Global Top 5 by 2020

Knowledge Foresight Desire & Innovation Association

Korea Food & Drug Administration

Scope of Policy Support

Scope of PoLicy sUpport

2) Supporting Globalization of Pharmaceutical Industry

Successful Relocation of Osong Health Technology 26 02 Administration Complex

Reinforcement of Cooperation with 33 04

Food and Drug Risk Prevention and Dissemination of 62 01 Safety Information

Integrated Control System of Risk Information and 70 02 Reinforcement of Analysis Capability

72 03 Introduction of an Advanced Operation System in Foods

Preventive and Scientific Management Infrastructure of Food Hazards 76 01

Conditions and Prospects of Biopharmaceutical Products 194 01 Administration

Current Status and Progress in Pharmaceutical Product Safety 152 01 Management

Establishment of Management System for Cosmetics and Sanitary 228 06 Aid

Establishment of Foundation for Supply of Safe and Effective 178 04 Pharmaceuticals

Improvement of Status of the Institute as an International 306 04

Upgrading National Prestige through Enhancing 316 05 International Cooperation

2. Tightened safety control from raw materials to consumption

3. Support for competitive new growth engine industries

5. Vitalization of communication to spread sympathy of safety

6. Strengthening cooperative system to establish safety basis

4) E xpansion of Autonomic Management for Minor Change in Medical Devices

1. Establishment of Cooperative Network with Consumer Organizations

2) Reinforcement of Cooperation by Organizing Meetings with Consumer Organizations

3) Civil Service and Professional Skill Consultation

2) I nnovation of KiFDA System and Civil Service

Table 1-5-2 Application for Clinical Statistics in 2009 to Early 2011

Figure 1-5-7 2 010 Clinical Statistics Workshop

Figure 1-5-6 2010-2011 Guidebooks for Clinical Statistics