当前我国仅委托生产的药品上市许可持有人存在问题及对策分析

Analysis on the Issues and Strategies for Marketing Authorization Holder Only Entrusting Production in China

2019年12月1日,新修订《药品管理法》正式生效后,我国开始实行药品上市许可持有人制度,仅委托生产的药品上市许可持有人作为一种全新业态,其数量在我国逐年快速增长。本文梳理了我国药品上市许可持有人法律法规体系,以及各省市制定的政策文件,分析了仅委托生产的药品上市许可持有人存在的问题,探讨了药品监管部门面临的挑战,并提出了对策建议。

Since the official implementation of the revised Drug Administration Law on December 1st,2019,China has adopted the Marketing Authorization Holder(MAH)system.As a completely novel model,the number of MAH only entrusting production has rapidly increased annually.This paper analyzes the laws and regulations concerning the MAH system formulated by the State,as well as policy documents established by provinces and cities.It also identifies the existing issues of MAH only entrusting production,discusses challenges faced by drug regulatory authorities,and provides strategies and recommendations.