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

作　　者：张磊[1] 朱夜琳 张海龙 ZHANG Lei;ZHU Ye-lin;ZHANG Hai-long(Anhui Medical Products Administration)

机构地区：[1]安徽省药品监督管理局

出　　处：《中国食品药品监管》2023年第11期92-97,共6页China Food & Drug Administration Magazine

摘　　要：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.

关 键 词：药品上市许可持有人 仅委托生产 问题分析 对策建议 

分 类 号：R95[医药卫生—药学]