我国药品上市许可持有人制度下的区域协作监管机制的完善
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篇名: 我国药品上市许可持有人制度下的区域协作监管机制的完善
TITLE: Perfection of Regional Cooperation Supervision Mechanism under Marketing Authorization Holder System
摘要: 目的:为完善我国药品上市许可持有人制度下的区域协作监管机制提供参考。方法:分析药品上市许可持有人制度下区域协作监管的对象及其法律责任,探讨区域协作监管存在的问题,并提出完善区域协作监管机制的建议。结果与结论:委托生产是药品监管部门跨区域协作监管的主要对象。药品上市许可持有人在药品的整个生命周期承担主体责任,受托生产企业承担补充责任。目前区域协作监管存在的问题主要包括缺乏有针对性的执法依据、监管力量不足、取证困难以及监管不及时、部门协作监管机制不健全等。建议从完善区域协作监管的执法依据、构建职业检查员制度、健全区域协作监管的联动机制、加强数据库建设等方面,完善我国药品委托生产的区域协作监管机制。
ABSTRACT: OBJECTIVE:To provide reference for perfecting regional cooperation supervision mechanism under the marketing authorization holder (MAH) system in China. METHODS :Based on the analysis of legal responsibilities of the MAH and entrusted manufacturing enterprise ,the problems were studied and suggestions for improving the regional cooperative supervision mechanism were put forward. RESULTS & CONCLUSIONS :Sub-contract production is the main target of cross-regional collaborative supervision of drug regulatory agencies. The MAH is responsible for the entire life cycle of the drug ,and the entrusted manufacturing enterprise assumes supplementary responsibility. At present , the problems of regional cooperation supervision are lacking of targeted legal enforcement basis ,insufficient supervision power ,difficulty in obtaining evidence , untimely supervision and inadequate department cooperation supervision mechanism. It is necessary to improve the regional cooperative supervision mechanism continuously in perspectives of perfecting legislation ,establishing professional inspector system,improving departmental linkage mechanism ,and strenghtening the database construction.
期刊: 2020年第31卷第15期
作者: 马韶青,司怡君,霍增辉
AUTHORS: MA Shaoqing ,SI Yijun,HUO Zenghui
关键字: 药品上市许可持有人制度;区域协作;监管机制;完善
KEYWORDS: MAH system ;Regional cooperation ;Supervision machanism ;Perfection
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