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药品上市许可持有人及相关主体的责权利分析

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新修订《药品管理法》全面实施药品上市许可持有人(MAH)制度,并将其作为基本制度、核心制度贯穿《药品管理法》.本文系统梳理了MAH及相关主体在药品全生命周期全环节享有的权利、应当履行的积极责任及应当承担的消极责任,并以药品委托生产为例,分析了MAH及相关主体责任义务落实情况,为MAH及相关主体明晰自身的主体责任、落实相关义务提供参考,以保障药品质量安全.
Analysis of Responsibilities and Rights of Marketing Authorization Holder and Relevant Entities
The implementation of the newly revised Drug Administration Law comprehensively incorporates the system of marketing authorization holder(MAH)and positions it as a foundational and central element within the framework of the law.This article systematically examines the rights,proactive responsibilities,and passive obligations enjoyed and assumed by MAH and relevant entities throughout the entire pharmaceutical lifecycle.Using drug contract manufacturing as an illustrative case,it scrutinizes the implementation of responsibilities and obligations by MAH and relevant entities.The aim is to provide guidance for clarifying primary responsibilities and fulfilling relevant obligations,ensuring the quality and safety of pharmaceuticals.

marketing authorization holderrelevant entitiesmain responsibilityanalysis of responsibilities and rightscontract production of drugs

李锦连、杨伊凡、谢金平、邵蓉

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中国药科大学药品监管科学研究院

国家药品监督管理局药品监管创新与评价重点实验室

药品上市许可持有人 相关主体 主体责任 责权利分析 委托生产

中国药品监督管理研究会课题江苏省教育厅2022年度江苏高校哲学社会科学研究一般项目中央高校基本科研业务费专项

2022-Y-Y-0142022SJYB00752632023PY03

2024

10.3969/j.issn.1673-5390.2024.02.005

中国食品药品监管
中国医药报社

中国食品药品监管

影响因子：0.099
ISSN：1673-5390
年,卷(期)：2024.(2)
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