我国药品上市许可持有人(MAH)制度实施路径问卷调研与结果分析  

A Questionnaire Survey and Result Analysis on the Implementation Pathway of the Marketing Authorization Holder(MAH)System in China

作　　者：李冬梅 陈震[3,4] 吴正宇 雷继峰 陈桂良 俞佳宁 刘颖 徐开祥 陈江鹏[4] 温东婷 杨建红 武志昂[4] LI Dong-mei;CHEN Zhen;WU Zheng-yu;LEI Ji-feng;CHEN Gui-liang;YU Jia-ning;LIU Ying;XU Kai-xiang;CHEN Jiang-peng;WEN Dong-ting;YANG Jian-hong;WU Zhi-ang(Shenyang Pharmaceutical University;BeiGene(Beijing)Co.,Ltd.;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;Baxter(China)Investment Co.,Ltd.;Yangtze River Pharmaceutical Group Co.,Ltd.;Center for Drug Evaluation,National Medical Products Administration)

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]郑州大学药学院 [4]沈阳药科大学亦弘商学院 [5]诺和诺德(上海)医药贸易有限公司 [6]上海安必生制药技术有限公司 [7]上海药品审评核查中心 [8]百特(中国)投资有限公司 [9]扬子江药业集团有限公司 [10]国家药品监督管理局药品审评中心

出　　处：《中国食品药品监管》2024年第4期32-49,共18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：目的:对我国药品上市许可持有人(MAH)制度实施过程中的关键问题及解决思路进行业内调研,为提出完善我国MAH制度实施路径的建议提供支持。方法:结合对我国MAH制度相关法规和实施过程中关键问题的梳理,以及对欧盟、美国、日本等国家和地区MAH监管体系的深入研究,提取了法规、监管制度及责任赔偿方面的关键问题,设计调研问卷,以医药行业专业人员为目标调研对象开展定向调研,并对调查结果进行分析。结果与结论:调研结果表明,多数调研对象对我国MAH制度在药品全生命周期各环节落地实施过程中的关键问题与解决思路有一定共识,同时也反映出部分关键问题的解决思路仍需要进一步探索。Objective:To investigate key issues and management elements of implementing the marketing authorization holder(MAH)system in China and to support related solutions and proposals.Methods:The study combines an analysis of the major issues in implementing relevant laws and regulations of the MAH system in China and in-depth investigation of MAH regulatory systems in Europe,the United States,Japan,and other countries and regions.Key issues in regulations,regulatory systems,and liability compensation are extracted,and a questionnaire survey is designed among pharmaceutical professionals.Results and Conclusion:The results of the survey reflect a consensus among most respondents on key issues and solutions for implementing the MAH system in the entire life cycle of drugs in China.Survey results also show that some key issues still need to be further explored.

关 键 词：药品上市许可持有人制度 实施路径 关键问题 解决思路 问卷调研 

分 类 号：R95[医药卫生—药学]