ICH Q-IWGIntegrated Training Programme课件.ppt

精品文档 ICH Quality Implementation Working Group - Integrated Implementation Training Workshop slide * ICH Q-IWG Integrated Training Programme International Conference on Harmonisation of TechnicalRequirements for Registration of Pharmaceuticals for Human Use Implementation of ICH Q8, Q9, Q10 ICH Q-IWGIntegrated Training Programme J.-L. Robert, Q-IWG Rapporteur Disclaimer The information within this presentation is based on the ICH Q-IWG members expertise and experience, and represents the views of the ICH Q-IWG members for the purposes of a training workshop. 精品文档 ICH: 20 years process (1) Start in 1990 (Brussels) Objective of ICH:Technical and scientific harmonisation between Japan, Europe and USA. Scope: New chemical entities and biotechnology derived products Sponsors: Regulators: EU, FDA, MHLW Industry: EFPIA, JPMA, PhRMA Observers: EFTA, Health Canada, WHO Steering Committee 精品文档 ICH: 20 years process (2) 1990: Pharmacopoeial Discussion Group EP, JP, USP, WHO 1997: Interested Parties: IGPA, WSMI 1999: Global Cooperation Group 2004 RHIs: APEC, ASEAN, GCC, PANDRH, GCG 2008 DRAs: Australia, Brazil, China, India, Russia, Singapore, South Korea 2008: DoH: Chinese Taipeh 2003: Quality New Paradigm 2006: Biotech Industry 2010: ICH Training: Implementation Q8, Q9, Q10 精品文档 Achieved so far (1) Areas Quality, Safety, Efficacy Multidisciplinary areas, MedDRA, e-submission,….. Initial ICH Quality topics Scientific/technical guidelines mostly: Stability, Method Validation, Impurities, Specifications, Q5 series (Biological) System oriented: GMP for APIs Structure: Common Technical Document 精品文档 Quality: A New Paradigm Develop a harmonised pharmaceutical quality system applicable across the lifecycle of the product emphasizing an integrated approach to quality risk management and science  Q8: Pharmaceutical Development Q8 (R2): Pharmaceutical Development Revision Q9: Quality Risk Management Q10: Pharmaceutical Quality System Q11: Development and Manufact