欧盟、美国、日本经验对我国药品上市许可持有人(MAH)制度实施中持证和生产关键问题的启示与借鉴  

Experiences in Europe,United States,and Japan for the Key Issues on Certificate Holding and Product Manufacturing During the Implementation of China's Marketing Authorization Holder(MAH)System

作　　者：吴正宇 刘颖 贾颖君 陈震[2,3] 杨建红 武志昂[3] WU Zheng-yu;LIU Ying;JIA Ying-jun;CHEN Zhen;YANG Jian-hong;WU Zhi-ang(Novo Nordisk(Shanghai)Pharmaceutical Trading Co.,Ltd.;School of Pharmaceutical Sciences,Zhengzhou University;Yeehong Business School,Shenyang Pharmaceutical University;Center for Drug Evaluation,National Medical Products Administration)

机构地区：[1]诺和诺德(上海)医药贸易有限公司 [2]郑州大学药学院 [3]沈阳药科大学亦弘商学院 [4]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20-31,共12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：药品上市许可持有人(MAH)与药品生产者可以是不同主体,实行持证和生产分离管理,是MAH制度的基本内容。我国既往是实行持证和生产合一的管理制度,要求MAH必须是该药品的生产企业。随着制药产业的发展和监管科学的进步,持证和生产合一管理制度下生产设施重复建设、药品主体责任落实不充分等问题日益突出,亟需建立和实施MAH制度,以持续强化MAH责任,合理调整实施持证和生产分离管理。本文着眼于行业需求反映突出的持证和生产问题,针对MAH跨境持证和生产管理、境外MAH的境内代理人及其职责管理、MAH与原料药持证和生产管理3个方面,分析当前监管措施和行业需求,剖析监管与需求之间的差异和难点,并针对这些差异和难点,对比分析了欧盟、美国、日本和我国的相关监管措施及监管特点、差异和成效,以期为完善我国MAH制度提供参考与借鉴。The marketing authorization holder(MAH)may or may not be the same as the drug manufacturer.The separation between the holder and the manufacturer is one of the essential aspects of the MAH system.Under the previous regulatory system in China,the holder-manufacturer-in-one restriction was implemented,requiring the MAH to hold the certificate of a drug product.With the development of the pharmaceutical industry and regulatory science,issues such as duplicate construction of production facilities and insufficient definition and enforcement of responsibilities of the drug holder under the holder-manufacturer-in-one system have become increasingly critical.It is necessary to establish the MAH system to strengthen the responsibilities of the MAH and the separation between the holder and the manufacturer.This article focuses on the key issues of certificate holding and product manufacturing reflected by industry demand,especially the current regulatory approaches and industry expectations on cross-border certificate holding and product manufacturing under an MAH.It also examines the foreign MAH-delegated local agent and its roles and responsibilities,as well as the relationship among the MAH,drug substance holder,and drug substance manufacturer.The gaps between supervision and demand,as well as challenges,are analyzed.To explore the reference for the implementation of China's MAH system,this article compares key points,differences,and performance of various regulatory measures in Europe,United States,Japan and China.

关 键 词：药品上市许可持有人 上市许可 生产许可 持证和生产 

分 类 号：R95[医药卫生—药学]