我国药品上市许可持有人制度变迁及建议

The Institutional Change and Suggestions of Pharmaceutical Marketing Authorization Holder in China

药品上市许可持有人(MAH)制度是一项国际上较为完善的药品注册制度,也是2019年新修订《药品管理法》的重要制度之一,这项制度贯穿了药品研制、生产、经营、使用全过程。当前《药品注册管理办法》《药品生产监督管理办法》《药品上市后变更管理办法(试行)》等配套法规的出台,有利于MAH制度的顺利实施,促进我国医药产业高质量发展。分析了我国药品上市许可持有人制度的探索、试点到实施的变迁过程,并就激发科研人员和企业的积极性和创造性,从MAH制度的主体、转让方式等方面提出建议。

As a relatively comprehensive drug registration system internationally,the drug marketing authorization holder(MAH)system is one of the important systems of the newly revised Drug Administration Law in 2019.The MAH system runs through whole process of the drug development,production,operation and usage.Currently,the promulgation of supporting laws and regulations such as measures for the administration of drug registration,measures for the supervision and administration of drug production and measures for the administration of post marketing changes of drugs(for trial implementation)is conducive to the smooth implementation of MAH system and promotes the high-quality development of China’s pharmaceutical industry.This paper analyzes the exploration,trial implementation and final implementation of pharmaceutical marketing authorization holder(MAH)system in China,and puts forward some suggestions on stimulating the enthusiasm and creativity of scientific researchers and enterprises from the aspects of the main body and transfer mode of MAH system.