我国药品上市许可持有人(MAH)制度实施路径中关键问题的建议  

Suggestions on the Key Issues of the Implementation Pathway of the Marketing Authorization Holder(MAH)System in China

作　　者：李冬梅 杨建红[3] 陈震[4,5] 吴正宇 雷继峰 陈桂良 王立新 刘颖 温东婷 牛佳玮 武志昂 张象麟 LI Dong-mei;YANG Jian-hong;CHEN Zhen;WU Zheng-yu;LEI Ji-feng;CHEN Gui-liang;WANG Li-xin;LIU Ying;WEN Dong-ting;NIU Jia-wei;WU Zhi-ang;ZHANG Xiang-lin(Shenyang Pharmaceutical University;BeiGene(Beijing)Co.,Ltd.;Center for Drug Evaluation,National Medical Products Administration;School of Pharmaceutical Sciences,Zhengzhou University;Yeehong Business School,Shenyang Pharmaceutical University;Novo Nordisk(Shanghai)Pharmaceutical Trading Co.,Ltd.;Shanghai Anbison Lab Co.,Ltd.;Shanghai Center for Drug Evaluation and Inspection;Center for Inspection of JSMPA;Baxter(China)Investment Co.,Ltd.)

机构地区：[1]沈阳药科大学 [2]百济神州(北京)生物科技有限公司 [3]国家药品监督管理局药品审评中心 [4]郑州大学药学院 [5]沈阳药科大学亦弘商学院 [6]诺和诺德(上海)医药贸易有限公司 [7]上海安必生制药技术有限公司 [8]上海药品审评核查中心 [9]江苏省药品监督管理局审核查验中心 [10]百特(中国)投资有限公司

出　　处：《中国食品药品监管》2024年第4期50-57,共8页China Food & Drug Administration Magazine

基　　金：沈阳药科大学亦弘商学院横向课题:我国药品上市许可持有人制度实施路径研究(YH-R-202001-0030)。

摘　　要：针对我国药品上市许可持有人(MAH)制度相关法规和实施过程中的主要问题,以及在对欧盟、美国、日本等国家和地区MAH监管体系深入研究的基础上提取的我国MAH制度实施中的关键问题,本文结合我国MAH制度实施路径问卷调研结果,围绕MAH落地实施的核心原则,在现行法规框架下,从MAH制度落地实施总体考虑和关键问题两个方面,提出完善我国MAH制度实施路径的建议。In view of the main issues in the relevant laws and regulations and implementation process of the marketing authorization holder(MAH)system in China,as well as the key issues in the implementation of MAH system in China extracted on the basis of in-depth research on the MAH regulatory systems in the European Union,the United States,Japan and other countries and regions,this article combines the results of the implementation path questionnaire survey,focus on the core principles of MAH implementation and under the current regulatory framework,and put forward suggestions for improving the implementation path of MAH system in China from two aspects:overall considerations and key issues for the implementation of the MAH system.

关 键 词：药品上市许可持有人制度 实施路径 关键问题 建议 

分 类 号：R95[医药卫生—药学]