我国药品定期安全性更新报告制度和医疗器械定期风险评价报告制度比较分析  

Comparative Analysis of China’s Periodic Safety Update Report System for Drugs and the Periodic Risk Assessment Report System for Medical Devices

作　　者：石辉 冯锋 SHI Hui;FENG Feng(Shaanxi Provincial Adverse Drug Reaction Monitoring Center;Shaanxi Medical Products Administration)

机构地区：[1]陕西省药品不良反应监测中心 [2]陕西省药品监督管理局

出　　处：《中国食品药品监管》2023年第4期52-61,共10页China Food & Drug Administration Magazine

摘　　要：目的:对比分析我国药品定期安全性更新报告(periodic safety update reports,PSUR)制度和医疗器械定期风险评价报告制度,为完善和改进我国药品和医疗器械上市后风险管理提供借鉴。方法:立足工作实际,通过查阅文献资料、数据统计、对比分析等,从实施背景、报告内容、实施现状以及监管运用四个方面,对我国药品PSUR制度和医疗器械定期风险评价报告制度进行比较和分析。结果:药品和医疗器械上市后风险报告制度的实施情况及效益,与行业认识及重视程度、法规支持及衔接程度密切相关。结论:贯彻落实药品和医疗器械上市后风险报告制度应结合实际并与时俱进,力求为药品和医疗器械科学监管提供有效的技术支撑。Objective:This study compares and analyzes China’s periodic safety update report system(PSUR)for drugs and the periodic risk assessment report system of medical devices,to provide experience for improving the post-marketing risk management of drugs and medical devices in China.Methods:Based on practical experience,we used methods such as literature review,data statistics,and comparative analysis to conduct a comparative analysis of the two systems from four aspects:implementation background,report content,implementation status,and regulatory application.Results:The implementation and effectiveness of the post-marketing risk reporting system for drugs and medical devices are closely related to the industry’s awareness and importance,and the regulatory support and integration.Conclusion:The implementation of the post-marketing risk reporting system for drugs and medical devices should be adapted to the actual situation and updated in a timely manner,aiming to provide effective technical support for scientific supervision of drugs and medical devices.

关 键 词：药品定期安全性更新报告 医疗器械定期风险评价报告 药物警戒 药品不良反应监测 医疗器械不良事件监测 

分 类 号：R95[医药卫生—药学]