中国药品技术审评概况.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