论风险管理在药品监管部门质量管理体系建设中的应用  

Application of Risk Management in Developing the Quality Management System for Drug Regulatory Departments

作　　者：张涛 陈旻[2] 周慧贤 邢立镛 隆颖[2] ZHANG Tao;CHEN Min;ZHOU Hui-xian;XING Li-yong;LONG Ying(Beijing Eastern Initiative Standard&Technology Co.,Ltd.;Guangdong Institute for Drug Control;Guangdong Medical Devices Quality Surveillance and Test Institute)

机构地区：[1]北京东方易初标准技术有限公司 [2]广东省药品检验所 [3]广东省医疗器械质量监督检验所

出　　处：《中国食品药品监管》2021年第8期114-119,共6页China Food & Drug Administration Magazine

基　　金：广东省中医药管理局科研项目:广东省中药饮片安全科学监管体系示范性研究(20201040);广东省药品监督管理局科技创新团队项目:WHO医疗产品国家监管体系评估全球基准工具(GBT)应用研究(2021TDZ04)。

摘　　要：药品管理的本质是风险管理,新修订《药品管理法》明确规定药品管理应坚持风险管理的原则。本文分析了药品监管部门实施风险管理的必要性、可行性,探讨了药品监管部门实施风险管理的具体步骤,包括风险管理模型构建、工作事项识别及梳理、风险识别、风险分析和评价、风险应对、检查与改进,以期帮助药品监管部门实施风险管理。The essence of drug regulation is risk management.The newly-revised Drug Administration Law clearly stipulates that drug administration shall adhere to the principle of risk management.This article analyzes the necessity and feasibility of implementing risk management by drug regulatory departments,and discusses the specific steps of implementing risk management by drug regulatory departments,including development of risk management model,identification and combing of work tasks,risk identification,risk analysis and evaluation,risk response,inspection and improvement.The aim is to help drug regulatory departments implement risk management.

关 键 词：工作事项 风险管理 风险识别 风险分析和评价 风险应对 

分 类 号：R95[医药卫生—药学]