我国药品上市许可持有人制度的实施情况及对策研究

The study on implementation and suggestions of drug marketing authorization holder in China

药品上市许可持有人制度是一种在国际上较为完善的药品注册制度。不同于我国先前上市许可与生产许可"捆绑式"的管理模式,药品上市许可制度的核心在于上市许可持有人和生产许可持有人可以相互独立。本文通过整理分析我国药品上市许可持有人制度试点的相关数据,了解该制度在试点的实施情况,并借鉴国外较完善的药品注册制度,对药品上市许可持有人制度在国内的顺利实施提供参考建议。

Drug marketing authorization holder( MAH) is a relatively completed drug registration system in the world. The core of drug MAH is that marketing authorization holder and production license holder could be independent of each other. This is different from the previous management mode of "bundling"of license and production license in China. This paper analyzed the relevant data of drug MAH pilot projects in China,confirmed their implementation,and learned the advantages of relatively completed drug registration system from foreign countries. Finally the study gave some suggestions on how to implement drug marketing authorization holder smoothly in China.