Overview of ICH

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Unique harmonisation initiative for regulators and pharmaceutical industry • Originally founded in 1990 • Reformed as a non-profit legal entity under Swiss Law on 23 October 2015

Promotion of public health through international harmonisation that contributes to: • Prevention of unnecessary duplication of clinical trials and post market clinical evaluations • Development and manufacturing of new medicines • Registration and supervision of new medicines • Reduction of unnecessary animal testing without compromising safety and effectiveness

Accomplished through Technical Guidelines that are implemented by the regulatory authorities.

▪ Founding Regulatory: ▪ EC, Europe; MHLW/PMDA, Japan; FDA, United States ▪ Founding Industry: ▪ EFPIA; JPMA; PhRMA ▪ Standing Regulatory: ▪ Swissmedic, Switzerland; Health Canada, Canada ▪ Regulatory: ▪ ANVISA, Brazil; NMPA, China; HSA, Singapore; MFDS, Republic of Korea; TFDA, Chinese Taipei ▪ Industry: ▪ BIO; Global Self-Care Federation; IGBA

30 Observers: ▪ Regulatory authorities; Regional Harmonisation Initiatives; international industry pharmaceutical organisations; international organisations regulated or affected by ICH Guidelines

MedDRA (Medical Dictionary for Regulatory Activities)

• Highly specific, standardised medical terminology developed by ICH to facilitate sharing of regulatory information • It is used for registration, documentation and safety monitoring of medical products both before and after marketing authorisation

Over 60 Guidelines on technical requirements on: • Safety – 14 Guidelines • Quality - 24 Guidelines • Efficacy – 21 Guidelines • Multidisciplinary - 7 Guidelines

Electronic Standards for the Transfer of Regulatory Information (ESTRI)

CTD/eCTD

MedDRA (standardised medical terminology)

Assembly is: • The overarching body of the Association, composed of all Members that take decisions, regarding Articles of Association, Rules of Procedures, admission of new Members, Adoption of ICH Guidelines, etc.

Management Committee is: • The body that oversees operational aspects of the Association on behalf of all Members, including administrative and financial matters and oversight of the WGs.

▪ The Management Committee provides: ▪ Recommendations on the selection of new topics for harmonisation as well as on the adoption, withdrawal or amendments of ICH Guidelines

▪ The Assembly takes decisions: ▪ By consensus ▪ In the absence of consensus: vote in accordance with the Articles of Association, where only regulatory members have the right to vote

Engagement in the ICH Process ▪ Past regular attendance in ICH meetings ▪ Past appointment of experts in WGs

Application of ICH Guidelines ▪ Have implemented at least the following ICH Guidelines (“Tier 1”): ▪ Q1: Stability Testing Guidelines ▪ Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

▪ E6: Good Clinical Practice Guideline

Data Entry Excel

Project ID: #24502517

About the project