我国药品上市许可持有人制度试点、实践探索与未来展望  

Pilot Program,Practical Exploration,and Future Outlook of the Marketing Authorization Holder System in China

作　　者：谢金平 杨伊凡 华焱钊 韩悦[1] 邵蓉[1] XIE Jin-ping;YANG Yi-fan;HUA Yan-zhao;HAN Yue;SHAO Rong(Institute of Regulatory Science for Medical Products,China Pharmaceutical University,NMPA Key Laboratory for Drug Regulatory Innovation and Evaluation)

机构地区：[1]中国药科大学药品监管科学研究院,国家药品监督管理局药品监管创新与评价重点实验室

出　　处：《中国食品药品监管》2024年第12期16-23,共8页China Food & Drug Administration Magazine

摘　　要：2019年新修订《药品管理法》明确全面实施药品上市许可持有人(MAH)制度。MAH制度是新修订《药品管理法》确定的基本制度,也是核心制度,是贯穿整部《药品管理法》的一条主线。我国MAH制度设计既接轨国际做法,又紧密贴合中国国情,释放了医药创新活力、优化了市场资源配置、夯实了主体责任、强化了监督管理,对于构建新时期药品监管制度体系、全面谱写中国式现代化药品监管新篇章意义深远。The newly revised Drug Administration Law(2019)clearly stipulates the comprehensive implementation of the marketing authorization holder(MAH)system.The MAH system,as a fundamental and core framework defined in the revised law,serves as a central thread running through the legislation.The design of China's MAH system not only aligns with international practices but also closely reflects China's specific national circumstances.It has invigorated pharmaceutical innovation,optimized market resource allocation,strengthened accountability of primary entities,and enhanced supervision and regulation.This system holds profound significance for constructing a modern drug regulatory framework in the new era and for opening a new chapter in China's modernization of pharmaceutical regulation.

关 键 词：药品上市许可持有人制度 委托生产 药品全生命周期管理 主体责任 创新激励 

分 类 号：R95[医药卫生—药学]