On ICH Feb. 13, 2013 Toshi Tominaga Ph. D. Food and Drug Evaluation Center, Osaka City Univ. Hospital International Regulatory Harmonization Amid Globalization.

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Presentation transcript:

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 Groups Q, S, E, M Secretariat

Membership Founding 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) Objective Global 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 ICH 1.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!