SEMINAR ON ICH GIDELINES

PRESENTED BY GUIDED BY DASHARATH DESAI Ms TEJAL SHAH

ICH GUIDELINE

A unique project that brings together the regulatory authorities of three regions and experts from the pharmaceutical industry to discuss scientific and technical aspects of product registration.

The Need to Harmonise

The realisation that it was important to have an independent evaluation of medicinal products before they are allowed on the market was reached at different times in different regions. 1. In the United States a tragic mistake in the formulation of a children's syrup in the 1930s was the trigger for setting up the product authorization system under the Food and Drug Administration.

2. In Japan, government regulations requiring all medicinal products to be registered for sale started in the 1950s. 3. In many countries in Europe the trigger was the thalidomide tragedy of the 1960s, which revealed that the new generation of synthetic drugs, which were revolutionizing medicine at the time, had the potential to harm as well as heal.

ICH REGIONS

European Union Japan United States

SIX FOUNDER MEMBERS of ICH

European Commission (EC) European Federation of Pharmaceutical Industries Associations (EFPIA) Ministry of Health, Labor and Welfare (MHLW) Japanese Pharmaceutical Manufacturers Association (JPMA) Food & Drug Administration (FDA) Pharmaceutical Research and Manufacturers of America (PhRMA)

OBJECTIVES

Initially regional (EU, USA & Japan, 1990)

Eliminate duplicative regulatory requirements, Use resources more efficiently and Ensure quicker access to safe, effective and good quality new pharmaceutical products

ROLE OF ICH GUIDELINES

ICH: 17 countries 15% world population 82% drug production 90% drug sales 95% R&D New Chemical Entities Chronic & lifestyle diseases

PHASE I (1991-1997)
Focused on the technical requirements for developing and registering products containing new drug substances, in these regions. Have developed over 40 guidelines for new drug products.

PHASE II (1998-CURRENT)
Develop a: mechanism to harmonize new technical requirements resulting from scientific progress and developments in innovative drug research; process for updating and supplementing current guidelines and monitoring their use, so that the benefits of harmoniszation achieved so far are

ICH TOPICS

"Quality" Topics, i.e., those relating to chemical and pharmaceutical Quality Assurance. "Safety" Topics, i.e., those relating to in vitro and in vivo pre-clinical studies.

Contd

"Efficacy" Topics, i.e., those relating to clinical studies in human subject. (E6) Good Clinical Practices "Multidisciplinary" Topics, i.e., cross-cutting Topics which do not fit uniquely into one of the above categories.

Medical Terminology (MedDRA) Electronic Standards Timing of Pre-clinical Studies in Relation to Clinical Trials

Quality Topics

Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9

Stability Analytical Validation Impurities Pharmacopoeias Quality of Biotechnological Product Specifications Good Manufacturing Practice Pharmaceutical Development Quality Risk Management

Safety Topics

S1 S2 S3 S4 S5 S6 S7 S8

Carcinogenicity Studies Genotoxicity Studies Toxicokineticsand Pharmacokinetic Toxicity Testing Reproductive Toxicology Biotechnological Products Pharmacology Studies Immunotoxicology Studies

Efficacy Topics

E1

Clinical Safety E2 Addendum to E2C: Periodic Safety Update Reports for Marketed Drugs E3 Clinical Study Reports E4 Dose-Response Studies E5 Ethnic Factors E6 Good Clinical Practice E7 Clinical Trials E12 Guidelines for Clinical Evaluation by Therapeutic Category E14 Clinical Evaluation

Multidisciplinary Topics

M1 Medical Terminology M2 Electronic Standards for the Transfer of Regulatory Information M3 Timing of Pre-clinical Studies in Relation to Clinical Trials M4 The Common Technical Document M5 Data Elements and Standards for Drug Dictionaries

CONTENTS OF ICH GUIDELINES

Preamble Objective Scope Drug Substance General Stress Testing Formal Studies Selection of Batches Test Procedures Specifications

Storage condition Testing Frequency Packaging containers Evaluation Statement\ Labeling Drug Product General Selection of Batches Specification Test Procedures

Storage Condition Testing Frequency Packing Containers Evaluation Statement\Labeling Annexure 1. Glossary and information

BENEFITS OF THE GUIDELINES

The exercise has helped in raising the standards of the quality, safety and efficacy parameters. ICH has helped to create methodology for diagnosing problems of drug development from a transitional perspective. The pharmaceutical companies have been a spared the meaningless burden of repeating tests under slightly different conditions to meet each regions requirement.

The benefits is directed to the patient who will have to wait less for the introduction of new treatments. The harmonization prevents unnecessary delays in the global development and availability of new medicines. Finally, the ICH has proved that industry and regulators can work constructively together in public interest when science is regarded to be more important than politics. As a principle, ICH has excluded the elements other than science and ethics in the discussion of ICH.

The excellent activities done by ICH in the areas of common medical terminology, electronic transmission of regularity information is certainly a leap towards use of information and communication technologies in the international transfer of regulatory information. The implementation of Electronic Standards for Transfer of Regularity Information (ESTRI) gateway will enable industry to submit regulatory information to authorities, and authorities to electronically exchange and share information among themselves.

REFERENCES

WWW..ICH.ORG The ICH Process, its Benefits and Implications, CRIPS, vol.1 ,No.1, 2000