INDEX WHAT IS ICH ? HISTORY INITIATION INTRODUCTION TOPICS QUALITY GUDILINES

ICH INTERNATIONAL CONFERENCE ON HARMONISATION (ICH) OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE.

WHAT ? An agreement between the European Union (EU), Japan and the United States (US) Joint initiative between government regulators and industry manufacturers.

WHY?  to harmonize regulatory requirements for the testing, application and approval process of pharmaceutical medications.

Historical Overview first attempt by the European Commission (EC) member nations during the 1980’s EC began bilateral discussions with both Japan and the United States

Specific plans began to materialize at the World Health Organization’s (WHO) Conference on Drug Regulatory Authorities in Paris in 1989 ICH was created in April 1990 at a meeting in Brussels Historical Overview

NEED FOR HARMONISATION RAPID INCREASE IN LAWS, REGULATIONS ANG GUIDELINES FOR TESTING SAFETY, QUALITY AND EFFICACY OF NEW PRODUCTS DIFFERENT TECHNICAL REQUIREMENTS BY REGULATORY AGENCIES, ALTHOUGH FUNDAMENTAL GUIDING PRINCIPLES SAME INDUSTRY BECOMING GLOBAL DUPLICATION OF TIME CONSUMING AND EXPENSIVE TESTING

PROGRESS TOWARDS INTERNATIONAL HARMONISATION GOALS :  DECREASE COUNTRY-TO- COUNTRY DIFFERENCES IN GUIDELINES  DECREASE DIFFERENCES BETWEEN REGULATORY AUTHORITIES

TARGET :  STREAMLINE DRUG DEVELOPMENT AND REGULATORY PROCESS  INCREASE EFFICIENCY AND ENFORCEMENT OF GMP, GLP AND GCP GUIDELIENS PROGRESS TOWARDS INTERNATIONAL HARMONISATION

ICH FOUNDER MEMBERS EUROPEAN UNION : EUROPEAN COMMISSION (EU) EFPIA (EUROPEAN FEDERATION OF PHARMACEUTICAL; INDUSTRIES, ASSOCIATIONS) JAPAN : MINISTERY OF HEALTH AND WELFARE JPMA ( JAPAN PHARMACEUTICAL MANUFACTURERS ASSOCIATION) USA : FDA PhRMA (PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA

Initiation of ICH Formation of steering committee Agreement on terms of references Expert working groups Eleven topics Four categories

Eleven possible topics to address divided into four main categories SAFETY QUALITY EFFICACY MULTIDISCIPLINARY

An ICH Guideline is FDA Guidance

STEERING COMMITTEE Monitors and Facilitates EWGs An EWG has 6 Topic Leaders - one from each ICH party Expert Working Groups

ICH Steering Committee Determines the policies and procedures for ICH Selects topics for harmonization Monitors the progress of harmonization initiatives Has two members for each of the six co-sponsors, the IFPMA and Observers

Expert Working Groups The Steering Committee assigns an EWG to each of the technical topics selected The groups are comprised of industry specialists on the topics discussed from each of the six members Do not have a fixed membership

QUALITY Q1 : STABILITY Q2 : ANALYTICAL VALIDATION Q3 : IMPURITIES Q4 : PHARMACOPOEIAS Q5 : BIOTECHNOLOGICAL QUALITY Q6 : SPECIFIACATIONS Q7 : GMP Q8 : PHARMACEUTICAL DEVELOPMENT Q9 : QUALITY RISK MANAGEMANT Q10: PHARMACEUTICAL QUALITY SYSTEM

Q1 Stability Testing Q1A(R2) Stability Testing of New Drug Substances and Products Q1B Photostability Testing of New Drug Substances and Products Q1C Stability Testing for New Dosage Forms

Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products Q1E Evaluation of Stability Data Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV Q1 Stability Testing

Q2 Validation Q2(R1) Validation of Analytical Procedures: Text and Methodology Q2A Text on Validation of Analytical Procedures Q2B Validation of Analytical Procedures: Methodology

Q3 Impurities Q3A(R) Impurities in New Drug Substances Q3B(R) Impurities in New Drug Products Q3C Impurities: Residual Solvents Q3C Tables and List

Q4-Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions Annex I: Residue on Ignition/Sulphated Ash General Chapter Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter

Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter

Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter

Annex 5: Disintegration Test General Chapter Annex 6:Uniformity of Dosage Units General Chapter Annex 7:Dissolution Test General Chapter Annex 8: Sterility Test General Chapter

Annex 9: Tablet Friability General Chapter Annex 10: Polyacrylamide Gel Electrophoresis General Chapter Annex 11: Capillary Electrophoresis General Chapter Annex 12: Analytical Sieving General Chapter

Q5 BIOTECHNOLOGICAL QUALITY Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products

Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products; Availability Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process Q5 BIOTECHNOLOGICAL QUALITY

Q6 SPECIFICATIONS Q6A International Conference on Harmonisation; Guidance on Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products

Q7A GMP Guidance for APIs This document is intended :  To provide guidance regarding GMP for manufacturing of API under an appropriate system for managing quality  To ensure that API meets the requirements of quality and purity

Q8(R2) Pharmaceutical Development To design a quality product and its manufacturing process to consistently deliver the intended performance of the product

Q9 Quality Risk Management It provides principles and examples of tools for Quality Risk Management that can be applied to different aspects of pharmaceutical quality such as :  Development  Manufacturing  Distribution  Inspection

Q10 Pharmaceutical Quality System It applies to Drug Substance and Drug Product including biotechnological and biological products throughout the lifecycle of the product.

ICH 1 ( NOVEMBER 1991) DEVELOPMENT OF TRIPARTITE AGREEMENT

ICH 2 (OCTOBER 1993) REVIEW OF PROGRESS TOWARDS HARMONISATION IN AREAS OF : EFFEICACY SAFETY QUALITY

ICH 3 ( NOVEMBER 1995) UPDATE STATUS OF : TRIPARTITE AGREEMENT PROGRESS TOWARDS HARMONISATION

ICH 4 ( JULY 1997) REIVIEW AND UPDATE OF THE IMPEMENTATION AND IMPACT OF ICH GUIDELINES

ICH 5 ( NOEMBER 2000) COMPLETION OF CTD(M4)

ICH 6 ( NOVEMBER 2003) continued development of new guidances did work on the implementation of existing guidelines

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