On ICH

Feb. 13, 2013

Toshi Tominaga Ph. D.Food and Drug Evaluation Center, Osaka City Univ. Hospital

International Regulatory Harmonization Amid Globalization of

Biomedical Research & Medical Product Development: An Institute of Medicine Workshop

International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for

Human Use (ICH) (since 1990)

• Objectives: – to improve efficiency of new drug development and

registration process– To promotepublic health, prevent duplication of

clinical trials in humans and minimise the use of animal testing without compromising safety and effectiveness

• Development and implementation of harmonized Guidelines and standards

Organization Structure

Steering Committee

Global Cooperation Group (GCG)

MedDRA Management Board

Working GroupsQ, S, E, M

Secretariat

MembershipFounding Members• Europe: EC/EMA, EFPIA• Japan: MHLW/PMDA, JPMA •United States: USFDA, PhRMA

Observers•WHO, Canada, EFTA

Interested Parties• International Generic Pharmaceutical Alliance(IGPA)• World Self Medication Industry (WSMI)• Biotechnology Industry• International Pharmaceutical Excipient Councils (IPECs)• API Industry

Drug Regulatory Authorities Regional Harmonization Initiatives

ICH Products• Over 50 Guidelines :

– Quality - 21 Guidelines– Safety - 14 Guidelines– Efficacy - 20 Guidelines– Multidisciplinary - 5 Guidelines

• Electronic Standards (ESTRI, E2B)• Common Technical Document (CTD & eCTD)• Medical dictionary for adverse event reporting and

coding of clinical trial data (MedDRA)• Consideration documents

Example “Stability Testing of New Drug Substances and

Products (Q1A(R2))”

Global Cooperation Group (GCG)

• ObjectiveGlobal implementation of ICH guidelines

• Members – Founding Members and Observers (since 1999)– Regional Harmonization Initiatives (RHIs) (since 2004) APEC, ASEAN, East African Community (EAC), Gulf

Cooperation Council (GCC), PANDRH, Southern African Development Community (SADC)

– Drug Regulatory Authorities (DRAs) (since 2008)Australia, Brazil, China, Chinese Taipei, India, Korea, Russia,

Singapore(- Experts from RHI/DRAs invited to EWG/IWG (2010))

Benefit of ICH1. For Industry– Reduced duplicate tests, reports, submissions

2. For Regulator– More consistent review, good review practice– Ease in cooperation b/w authorities

3. For Public– Quicker access to safe and effective drugs

4. For Japan– Revamping outdated clinical trial system (ICH GCP(E6))– Rationalize requirements based on ethnic factors (E5)• Continued to current discussion on Multi-regional CTs

ICH: Keys to success

• Well-defined process and Effective management • Commitment to implement product Guidelines• Concentration on Technical Requirements

Regulatory Decision

Regulation, Procedures

Technical Requirements

Levels of Harmonization

Thank you for your attention!