关于省级药品审评检查协同监管机制的研究、设计及示例运用  

Research,Design,and Application of the Provincial Drug Evaluation Inspection Collaborative Supervision Mechanism

作　　者：邹任贤 李月 ZOU Ren-xian;LI Yue(Shanghai Center for Drug Evaluation and Inspection;ECNU-SCDEI Collaborative Research Center for Drug Regulatory Science)

机构地区：[1]上海药品审评核查中心 [2]华东师范大学-上海药品审评核查中心药品监管科学联合研究中心

出　　处：《中国食品药品监管》2024年第9期140-149,共10页China Food & Drug Administration Magazine

摘　　要：目的:本研究旨在探索和构建有效的省级药品审评与检查协同监管机制,以提升药品监管决策的效率和质量。方法:采用文献调研和问卷调研的方式分析省级层面的协同监管现状及存在的问题。结果:审评检查协同是落实全生命周期监管的新方向,美国食品药品监督管理局(FDA)在药品审评检查协同方面的探索为我国提供了重要启示。目前,我国省级药品监管部门在协同监管方面已有一定进展,但仍存在信息共享不足、监管流程不顺畅等问题。结论:本研究提出了构建省级药品审评检查协同监管机制的思路,包括以风险导向、全程管控、共治共享为原则,建立一个以国家药品智慧监管平台为核心的监管数据交互体系,以及在不同层面上实施协同监管的具体措施。Objective:This study aims to explore and establish an effective provincial-level drug evaluation and inspection collaborative regulatory mechanism to enhance the efficiency and quality of drug regulatory decisions.Methods:Literature review and questionnaire surveys were used to analyze the current status and issues of collaborative regulation at the provincial level.Results:The findings indicate that review and inspection collaboration represent a new direction for implementing life-cycle management of drugs.The explorations of the FDA in this area provide important insights for China.Currently,provincial drug regulatory authorities in China have made some progress in collaborative regulation.However,issues such as insufficient information sharing and unsmooth regulatory processes still exist.Conclusion:This study proposes a framework for building a provincial drug evaluation and inspection collaborative regulatory mechanism,emphasizing risk orientation,full process control,and co-governance sharing.The study suggests establishing a regulatory data interaction system centered on the national intelligent regulatory platform and implementing specific collaborative regulation measures at various levels.

关 键 词：省级药品监管 审评检查协同 风险闭环 机制研究 示例运用 

分 类 号：R95[医药卫生—药学]