drug technical evaluation in China 冯毅2011.pdf

中国药品技术审评概况 中国药品技术审评概况 Drug Technical Evaluation in China Drug Technical Evaluation in China 国家药品监督管理局药品审评中心冯毅 Mr. YI Feng ，Centre for Drug Evaluation State Drug and Food Administration 内 容 Content 内 容 Content • 法规和监管部门 • 法规和监管部门 Legislation and Responsible Organization Legislation and Responsible Organization • 药品注册 Drug Registration • 药品注册 Drug Registration • 药品技术审评 Drug Technical Evaluation • 药品技术审评 Drug Technical Evaluation • 面临的挑战 Challenge • 面临的挑战 Challenge 法规和监管部门（1） 法规和监管部门（1） Legislation and Responsible Organization(1) Legislation and Responsible Organization(1) • 《药品管理法》 Drug Administration Law of P. R. China • 《药品管理法》 Drug Administration Law of P. R. China – 生产、经营、医院制剂、药品管理等 – 生产、经营、医院制剂、药品管理等 – Manufacturers ，Distributors ， Pharmaceuticals in Medical Institutions – Manufacturers ，Distributors ， Pharmaceuticals in Medical Institutions Drug Administration ，etc Drug Administration ，etc • 《药品管理法实施条例》 • 《药品管理法实施条例》 Regulations for Implementation of the Drug Administration Law of P. R. China Regulations for Implementation of the Drug Administration Law of P. R. China – 上位法的细化 Detail Requirements of the Law – 上位法的细化 Detail Requirements of the Law – 定义新药、监护期、资料保护等 – 定义新药、监护期、资料保护等 Definition of New Drug, Period of monitoring for New Drug, Data Protection，etc Definition of New Drug, Period of monitoring for New Drug, Data Protection，etc • 《药品注册管理办法》 Provisions for Drug Registration • 《药品注册管理办法》 Provisions for Drug Registration – 定义药品注册 Definition of the Drug registration – 定义药品注册 Definition of the Drug registration – 注册工作的各项程序 Procedure – 注册工作的各项程序 Procedure – 药品的分类 Category of Dru