我国药品监管质量管理规范(GRP)体系标准和流程建设研究  

Research on the Construction Standard and Process of China’s Good Regulatory Practice(GRP)

作　　者：胡骏 HU Jun(Shanghai Center for Adverse Drug and Medical Device Reaction Monitoring)

机构地区：[1]上海市药品和医疗器械不良反应监测中心

出　　处：《中国食品药品监管》2023年第9期80-89,共10页China Food & Drug Administration Magazine

基　　金：2022年中国药品监督管理研究会课题(2022-Y-Y-012)。

摘　　要：药品监管质量管理规范(GRP)体系标准和流程建设研究,对推进监管业务流程优化,实现全生命周期管理,对标国际、对标产业、对标监管,实现中国式药品监管现代化发展具有重要意义。通过对GRP体系标准和流程建设的相关问题进行研究,并采用社会网络分析方法(SNA)对省级“十四五”规划的重点任务进行管理体系分析,本文提出国家、省和市县3级岗位编制GRP体系标准(8项管理体系)的建设框架,以及提出数字化监管、属地责任考评、国际互认协议相融合和试点实践等政策性建议。The construction standards and processes of the Good Regulatory Practice(GRP)are effective in promoting the optimization of regulatory business processes,achieving full life cycle management,benchmarking international practices,industry standards and regulatory resources.It plays a crucial role in achieving Chinese-style modernization development in drug regulation.This study focuses on the relevant issues of GRP standards and process construction,and utilizes the Social Network Analysis(SNA)method to analyze the management system of key tasks in the provincial 14th Five Year Plan.The article proposes a construction framework for GRP standards system(consisting of 8 management systems)at the national,provincial,and city/county levels.Additionally,policy recommendations are provided,including digital supervision,territorial responsibility assessment,integration of international mutual recognition agreements,and demonstration practices.

关 键 词：药品监管质量管理规范(GRP) 管理体系 标准和流程 政策性建议 

分 类 号：R95[医药卫生—药学]