变革中持续探索探索中立足国情--再谈我国药品上市许可持有人制度

Continuing Reform Based on National Conditions--Insights on the Marketing Authorization Holder System in China

2019年新修订《药品管理法》将药品上市许可持有人(MAH)制度正式从法律层面确定,此后新修订《药品注册管理办法》《药品生产监督管理办法》《药品委托生产质量协议指南》等规章、指南对MAH制度具体细化,构建了符合中国国情的MAH制度。MAH制度是贯穿整部《药品管理法》的主线,也是一项颠覆性变革,对监管理念和传统认知都带来了挑战。随着MAH制度的推行,为更好地落实MAH及相关主体责任,科学地做好变更管理,更好地设计跨境持有与生产等管理模式,应对跨省监管带来的挑战等,需要结合我国国情在实践中持续探索、不断完善,以实现释放创新活力,优化产业和行政监管资源配置,促进医药产业发展,同时满足公众用药需求的目标。

The newly-revised Drug Administration Law of 2019 formally established the Marketing Authorization Holder(MAH)system by law.Since then,the newly-revised Provisions for Drug Registration,Provisions for the Supervision and Administration of Drug Manufacturing,the Quality Agreements Guidelines for Drug Contract Manufacturing,and other regulatory documents have specified the details of the MAH system,and a MAH system tailored for China’s national conditions is taking shape.The MAH system is a central theme of the Drug Administration Law,and it is a fundamental change that challenges the regulatory concept and tradition.With the implementation of the MAH system,it is important to better implement the responsibilities of the MAH and related subjects,better manage changes,better design management of cross-border holding and manufacturing,meet the challenge of cross-provincial supervision and so on.We need to continue to explore and improve the MAH system in practice based on China’s national conditions in order to achieve the goals of facilitating innovation,optimizing the allocation of industry and regulatory resources,promoting the development of pharmaceutical industry and meeting public needs for drug use.