UNITED STATES FOOD AND DRUG ADMINISTRATION(USFDA)

The U.S. Food and Drug Administration is

Scientific, Regulatory, Public Health Agency

Mission is to protect and promote public health Authority to regulate medical devices
Federal FD&C Act

Established regulatory controls for medical devices (May 28, 1976)

one of the United States federal executive departments, responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.

Basic Mission
Safety
Efficacy
Drugs

Medical Devices

Truthful Labeling
Adulteration Misbranding

Organization
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health, Center for Drug Evaluation and Research Center for Food Safety and Applied Nutrition Center for Tobacco Products Center for Veterinary Medicine National Center for Toxicological Research Office of Regulatory Affairs

FDA Centers and Regulated Products

Food Drugs Medical Devices * Biologics Animal Feed and Drugs Cosmetics Radiation-Emitting Products * Combination Products
CVM Center for Veterinary Medicine

*
CDRH Center for Devices and Radiological Health CDER Center for Drugs and Evaluation Research CBER Center for Biologics and Evaluation Research

FDA
CFSAN Center for Food Safety and Applied Nutrition

(drug-device*, biologic-device*, drug-biologic)

NCTR National Center for Toxicological Research

 FDA regulates:
Foods safety of all food products

(except for most meat and poultry products, which are regulated by the U.S. Department of Agriculture)
labeling bottled water food additives infant formulas Dietary Supplements Human Drugs product approvals

OTC and prescription drug labeling

drug manufacturing standards

 Vaccines, Blood Products, and Other Biologics

product and manufacturing establishment licensing safety of the nation's blood supply research to establish product standards and develop

improved testing methods Medical Devices from simple items like tongue depressors, to complex technologies such as heart pacemakers premarket approval of new devices manufacturing and performance standards tracking reports of device malfunctioning and serious adverse reactions

Electronic Products
products that give off radiation, such as microwave ovens and X-ray equipment radiation safety performance standards for microwave ovens, television receivers, diagnostic

x-ray equipment, cabinet x-ray systems (such as baggage x-rays at airports), laser products,
ultrasonic therapy equipment, mercury vapor lamps, and sunlamps accrediting and inspecting mammography facilities

Cosmetics
Safety,labeling Veterinary Products livestock feeds , pet foods

veterinary drugs and devices

veterinary biologics not regulated by USFDA are considered new animal drugs Tobacco Products

 FDA does not regulate:

advertising (except for prescription drugs, medical devices, and

tobacco products)
alcoholic beverages some consumer products, such as paint, child-resistant packages,

baby toys, and household appliances (except for those that give off radiation)
illegal drugs of abuse, such as heroin and marijuana health insurance meat and poultry (except for game meats, such as venison, ostrich,

and snake)
restaurants and grocery stores vaccines for infectious animal diseases

Inspections and legal sanctions

: FDA investigators and inspectors collect domestic and

imported product samples for scientific examination and for label checks. If a company is found violating a law that FDA enforces, FDA can encourage the firm to voluntarily correct the problem or to recall a faulty product from the market. When a company can't (or won't) correct a public health problem with one of its products voluntarily, FDA has legal sanctions it can bring to bear. FDA can go to court to force a company to stop selling a product and to have items already produced seized and destroyed. When warranted, criminal penalties--including prison sentences--are sought against manufacturers and distributors.

Product recalls:
About 3,000 products a year are found to be unfit for consumers and are withdrawn from the marketplace, either by voluntary recall or

by court-ordered seizure. In addition, about 30,000 import shipments a year are detained at the port of entry because the goods appear unacceptable

Investigational studies
Biologics
IND- Investigational new drug application

Drugs
IND- Investigational new drug application

DEVICES
IDE- Investigational devices exeptions

COMBINATION PRODUCTS

Examples of Device Classes

Medical Device Classes:
Class I General Controls Most exempt from premarket submission Class II Special Controls Premarket Notification [510(k)] Class III
Require Premarket Approval [PMA]
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Clinical Trials
Phase I What are the side effects? Is it safe enough to test? Phase II Does it work at all? What is the dosage range? Phase III Is it better than placebo? Is it better than other treatments? What are the side-effects

Premarket approval pathway

Biologics

IND Investigational new drug application Drugs NDA New drug application Devices IDE-Investigational device exemption Combination products

Drugs and Biologics Marketing regulations

21 CFR parts 210,211,225,&226 good manufacturing practices for drugs and biologics 21 CFR parts 600,601,&610 biologicals products regulations *21 CFR parts 201,202,203,314

prescription drug regulation *21 CFR parts 25 Environmental impact considerations

What does FDA inspect?

FDA inspects manufacturers or processors of FDA-regulated products to verify that they comply with relevant regulations. Those inspected include vaccine and drug manufacturers blood banks food processing facilities dairy farms animal feed processors FDA also inspects facilities that conduct studies in people (clinical trials) laboratories that conduct studies in animals or microorganisms when these studies are used to apply for FDA approval of a medical product foreign manufacturing and processing sites for FDA-regulated products that are sold in the United States imported products at the border

16 Classification Regulations
21 CFR (part 800-1299)

Clinical chemistry and clinical

toxicology Hematology and pathology Immunology and microbiology Anesthesiology Cardiovascular Dental Ear, nose and throat Gastroenterology & urology devices

General and plastic surgery General hospital and personal

use Neurological Ophthalmic Orthopedic and physical medicine Obstetrical and gynecological Radiology

Medical Device Definition in Sec 201(h) of the FD&C Act

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Two Most Common Pathways to Market in the U.S.

Premarket Notification (PMN or 510(K))

Safe and effective to a legally marketed (predicate) device through demonstration of substantial equivalence Class I, II, or III (pre-amendment)

Premarket Approval (PMA)

Demonstration of safety and effectiveness (supported by clinical data) Class III (new, high risk devices and no predicate device, new indications)

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Drug Application Types application types Drug

A New Drug Application (NDA) contains full

reports of safety and efficacy studies conducted by or for applicant or as to which it has right of reference
An Abbreviated New Drug Application (ANDA) is

for a generic duplicate of an approved NDA product:

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Legal Import of Medical Devices into the U.S. Market Section 801(a) (d) of the FD&C Act Subject to examination by Establishment Registration FDA even if the product is Medical Device Listing authorized for marketing in Compliant Labeling another country. GMP/Quality Systems Devices must be safe and Appropriate Marketing effective. Applications unless exempt Must contain informative 510(k) and truthful labeling in English. PMA Imported products are Adverse Event Reporting, required to meet the same Records/Complaint Files standards as domestic goods.

What are General Controls?

Basic authorities that provide FDA with the means to regulate medical devices.
Applies to all medical devices regardless of classification, are subject to premarket and postmarket regulatory controls.

Establishment registration and device listing Premarket notification or 510(k), if not exempt Labeling

Misbranding
Adulteration Quality Systems Records and Reports / Medical Device Reporting (MDR)

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Summary

If a product is labeled, promoted or used in a manner defined in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act, it will be regulated by the FDA as a medical device.
USFDA CDRHs regulatory paradigm is risk-based classification. The levels of regulatory control are based on the classification. Unless exempt, they require a premarket notification clearance or a premarket approval application. In entering the U.S. medical device market,

First determine if it meets definition of medical device. Then determine how the may FDA classify the device, if known. Finally, gather your information, collect the necessary data, organize your submission.

Products imported into the U.S. meets the same standards and requirements as domestic goods.

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Australian TGA The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health and Ageing, and is responsible for regulating therapeutic goods including medicines, medical devices, blood and blood products. This includes goods that we rely on every day, such as sunscreens, through to goods used to treat serious conditions, for example prescription medicines, vaccines, blood products and implants. Essentially, any product for which therapeutic claims are made must be listed, registered or included in the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia.

 The TGA evaluates therapeutic goods before they are

marketed and monitors products once they are on the market, it also assesses the suitability of medicines and medical devices for export from Australia. The TGA also regulates manufacturers of therapeutic goods to ensure they meet acceptable standards of manufacturing quality. It has a team of manufacturing inspectors that audit manufacturing facilities around the world to ensure that products supplied in Australia are of high quality. The TGA administers the Therapeutic Goods Act 1989. This legislation provides a framework for a risk management approach that allows the Australian community to have timely access to therapeutic goods which are consistently safe, effective and of high quality.

 The TGA works with consumers, health professionals,

industry and its international counterparts in order to effectively regulate increasingly complex products resulting from rapid scientific developments. The TGA does not regulate: veterinary medicines food health insurance cosmetics chemicals healthcare professionals.

 TGA Executive
The TGA Executive has overall responsibility for the

management of the TGA's regulatory functions and activities. The TGA Executive comprises: TGA National Manager, Dr John Skerritt Principal Medical Adviser, Dr Tony Gill (Acting) Principal Legal Adviser, Ms Philippa Horner Head, Market Authorisation Group, Ms Judy Develin (Acting) Head, Monitoring & Compliance Group, Dr Larry Kelly (Acting) Chief Operating Officer, Ms Jill Jepson Head, ANZTPA Project Team, Ms Margaret Lyons

 Market Authorisation Group

The Market Authorisation Group (MAG) is responsible for

undertaking evaluations of applications to approve new therapeutic products for supply in Australia. The MAG makes decisions whether to approve or reject market authorisation of medicines, medical devices and blood and tissues that are imported, exported, manufactured and supplied in Australia. The Offices and Units in the MAG are: Office of Medicines Authorisation (OMA) Office Head (Acting): Dr Peter Bird The OMA is responsible for approving prescription and non-prescription medicines

 Office of Complementary Medicines (OCM)

Office Head (Acting): Ms Trisha Garrett The OCM is responsible for approving complementary

medicines, including traditional and herbal medicines and vitamin and mineral supplements. Office of Devices Authorisation (ODA) Office Head (Acting): Ms Irina Tsyganova The ODA is responsible for approving medical devices, including in vitro diagnostic medical devices (IVDs).

 Office of Scientific Evaluation (OSE)

Office Head: Dr Mark McDonald The OSE provides scientific advice to support the

decisions made by the Market Authorisation Group. This includes clinical, toxicological, biological sciences and pharmaceutical chemistry evaluation of therapeutic products. It also includes the Experimental Products Unit which is responsible for the evaluation and authorisation of certain clinical trialsand special access arrangements for all types of therapeutic products. Group Support Unit (GSU) The GSU is responsible for providing planning, coordination and administrative services to all areas of the Group.

 Monitoring and Compliance Group

The Monitoring and Compliance Group (MCG) is

responsible for ongoing monitoring of therapeutic products approved for supply in Australia to ensure they meet the necessary standards throughout their lifecycle. The way our medicines and devices are manufactured is also regulated by the TGA. Australian and international manufacturers must operate in a manner that results in products meeting specified standards if they are to be supplied in Australia. The TGA conducts regular inspections of manufacturers, both in Australia and overseas, to ensure they continue to meet these standards.

 The Offices and Units in the MCG are:

Office of Product Review (OPR) Office Head: Dr Jane Cook The OPR is responsible for overseeing all therapeutic

products to ensure they continue to maintain an appropriate level of quality, safety, efficacy and performance following entry into the Australian marketplace. This includes monitoring reports of adverse events and reviewing medicine ingredients and device components. The Advertising and Recalls Unit also sits within OPR and is responsible for administering legislative requests for the advertising of therapeutic goods in Australia and coordinating product recalls when necessary.

What are 'therapeutic goods'?

Many of us use medicines or medical devices in our daily lives. When

we:
apply a bandage

relieve a headache with items from the supermarket

take echinacea , receive an injection, or undertake a prescribed course of treatment to manage a serious

illness.
In relation to the evaluation, assessment and monitoring done by

the TGA, therapeutic goods are broadly defined as products for use in humans in connection with:
preventing, diagnosing, curing or alleviating a disease, ailment,

defect or injury
influencing inhibiting or modifying a physiological process testing the susceptibility of persons to a disease or ailment influencing, controlling or preventing conception

testing for pregnancy

 This includes things that are:

used as an ingredient or component in the manufacture

of therapeutic goods; or used to replace or modify of parts of the anatomy, or Some products, even though they may technically meet the definition of a therapeutic good, are declared not to be therapeutic goods under section 7 of the Therapeutic Goods Act 1989.

Canadian HPFBI Health products and food branch has developed a policy that promotes a more open and transparent system for regulating the safety and effectiveness of health product and food. Recognizes that input from citizens and stakeholders is an important source of evidence in regulatory decision making about benefits and risks. In june 2005, the office of consumer and public involvement of health products and food branch started developing the policy on public input into the review of health products. This initiative began with a broader environment that includes increased citizen demands in canada and abroad for the opportunity to participate in decisions that affect their health.

 Govt commitments to greater accountability , openness

and transparency , coupled with an absence of supporting policy framework appropriate to the regulatory context. The objective set out for the policy development team was to articulate health canadas visit for public input in the review of a health product . The Policy on Public Input into the Review of Health Products situates public input as an important source of evidence in assessing and managing the risks associated with a health product. As a regulator, the Health Products and Food Branch (HPFB) recognizes that the benefits of the health products it regulates are usually accompanied by some degree of risk.

 , the Health Products and Food Branch is committed to

the following: Independence and accountability in decision making. The Health Products and Food Branch makes decisions on a regulated product objectively, independently, and without bias, according to its legislated mandate under the Food and Drugs Actand regulations. Making decisions in the public interest. Health Canada 's mission is to help "the people of Canada maintain and improve their health." Regulatory decisions in the public interest require Health Canada to identify and assess the safety and effectiveness of a regulated product to determine the level of acceptable risk weighed against the product's benefits.

 Openness and inclusiveness in our review process. The

Health Products and Food Branch recognizes that public input from a variety of sources can lead to more informed analysis of the safety and effectiveness of a regulated product. Transparency. To allow for informed public input while also respecting the privacy of individuals and confidential business information, the Health Products and Food Branch will provide the public with sufficient information on the review of a regulated product and the issues under consideration. Timeliness. The Health Products and Food Branch will inform the public of opportunities to provide input as soon as possible and will always endeavour to give the public enough time to prepare.

 hpfbi
The regions include Atlantic, Manitoba and

Saskatchewan, Ontario, Quebec, Alberta, and British Columbia. The Inspectorate's current responsibilities include the management of inspection and the assessment of conformity to standards related to the fabrication, packaging/labelling, testing, importation, distribution and wholesaling of marketed health products for human and veterinary use. The Inspectorate is also responsible for the management of investigations and other monitoring activities as well as enforcement strategies related to the fabrication, packaging/labelling, testing, distribution, importation and wholesaling of marketed health products for human and veterinary use;

 Mutual Recognition Agreements (MRAs) and other

international agreements with different Regulatory Authorities concerning Good Manufacturing Practices (GMP) for human and veterinary pharmaceuticals The inspection and the assessment of conformity to the Good Clinical Practices (GCP) regulatory requirements including the research performed on humans during clinical trials involving pharmaceuticals, biological products and genetic therapies; and, the communication and education functions related to each of the above activities.

Indian CDSCO {central drugs standard control organisation}

Objective: to ensure that medicinal products are of acceptable

quality, safety and efficacy, are manufactured and distributed in ways which ensure their quality until they reach the patient and their commercial promotion is accurate .
Indian CDSCO is a licensing authority for the approval of new drugs

proposed to be imported as well as the amount of drugs to be imported.

In 1940 D &C act was passed in order to regulate import,

manufacture, distribution and sale of drugs in india.

Drug rules were framed in 1945 In 1985 narcotic and psychotropic substances act. CDSCO under ministry of health and family welfare largely works on

 CDSCO under ministry of health and family welfare

largely works on Developing standards and regulatory measures for drugs, diagnostics and devices. Laying down regulatory measures by amending acts and rules. Regulating market authorization of new drugs. Works with Drugs technical advisory board, Drugs consultative committee and central drugs laboratory.

 Other functions: Screening of drug formulation available in indian market. Monitoring adverse drug reactions. Participation in WHOs GMP certification.

Screening of applications for granting NOC for export of

unapproved or banned drugs. Headquarters at FDA bhawan New Delhi, functions under directorate general health services Staff details: 1. Drugs controller general of India. 2. Joint drug controller of India. 3. Deputy director general (drugs) 4. Deputy director administration (drugs) 5. Assistant drug controllers of india. 6. Technical officers.

 Zonal offices
1. Mumbai

2. Kolkata 3. Chennai 4. Ghaziabad Sub zonal 1. Ahmedabad 2. Hyderabad

CDSCO Drugs controller general

Head Qtrs

zonal sub zonal office office

port office

laboratory

New dgs GMP audits GMP audits Imports coordination DTAB with states

Import/ testing of export drug samples validation of

Function of CDSCO
approval of new drugs and clinical trails import registration and licensing licensing of blood banks , vaccines, rdna products and some medical devices and diagnostic agents. amendment to D&C act and rules banning of drugs and cosmetics grant of test license , personal license NOCs for export. testing of drugs.

 Structure at state level

state drugs control organisation

Drugs controller commissioner deputy drugs controller drug inspector

drug testing laboratory government analyst analyst

supporting staff

supporting staff