1 / 14

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.

xandy
Download Presentation

On ICH

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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!

More Related