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On ICH

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.

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On ICH

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  1. On ICH Feb. 13, 2013 ToshiTominaga 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

  2. 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

  3. Organization Structure Steering Committee Global Cooperation Group (GCG) MedDRA Management Board Secretariat Working Groups Q, S, E, M

  4. 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

  5. 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

  6. Example “Stability Testing of New Drug Substances and Products (Q1A(R2))”

  7. 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))

  8. Benefit of ICH • For Industry • Reduced duplicate tests, reports, submissions • For Regulator • More consistent review, good review practice • Ease in cooperation b/w authorities • For Public • Quicker access to safe and effective drugs • 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

  9. ICH: Keys to success Well-defined process and Effective management Commitment to implement product Guidelines Concentration on Technical Requirements

  10. Levels of Harmonization Regulatory Decision Regulation, Procedures Technical Requirements

  11. Thank you for your attention!

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