ICH和Q4B 药典要求和协调指导原则 默克.pdf

ICH and Q4B Pharmacopeias Harmonization Lionel Randon th Beijing 30 November 2018 Overall introduction on ICH ICH’s mission is to HARMONIZE global regulatory requirements to ensure safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use Objectives Intended Benefits • Harmonize criteria and documents required for • Prevent clinical trial duplication approval and authorization of new medicinal • Minimize use of animal testing without products across different regions compromising safety and effectiveness • Improve efficiency of new drug development and • Streamline submission preparation and regulatory facilitate faster patient access to new, safe, and processes, providing better use of limited resources effective drugs • Share industry/regulatory experience and • Create venue for involvement of both regulatory knowledge and industry stakeholders in harmonization work Harmonisation does not mean loss of national sovereignty/autonomy Provides platform for better commu