韩国药物警戒体系介绍及启示  

Introduction and enlightenment of pharmacovigilance systems in Sout h Korea

作　　者：张雅娟 江阳 ZHANG Yajuan;JIANG Yang(School of Pharmaceutical Science,Tsinghua University,Beijing 100084,China;School of Business Administration,Shenyang Pharmaceutical University,Shenyang Liaoning 110015,China)

机构地区：[1]清华大学药学院,北京100084 [2]沈阳药科大学工商管理学院,辽宁沈阳110015

出　　处：《中国药物警戒》2022年第10期1082-1086,共5页Chinese Journal of Pharmacovigilance

基　　金：国家药品监督管理局典型国家药物警戒体系研究项目(20202001532);国家药品监督管理局国际创新药上市后药物警戒监管法律法规及方式方法研究项目(20202001623)。

摘　　要：目的分析韩国药物警戒体系,为我国药物警戒体系的建设提供建议。方法通过分析韩国药物警戒组织体系、法律法规和监测报告系统,与我国药物警戒体系进行比较,从优化药物警戒技术机构职能、完善药物警戒报告系统、开发合理用药等方面为我国药物警戒制度建设提供借鉴。结果与结论韩国根据新修订《药事法》,提升了药物警戒监管能力,通过建立药品安全与风险管理研究所,完善了药物警戒监测和报告系统;我国应当优化药物警戒技术机构职能,完善药物警戒报告系统,开展合理用药的评价。Objective To analyze the current pharmacovigilance system policies in South Korea and give advice on the construction of pharmacovigilance systems in China.Methods By analyzing the organizational system,laws and regulations,and the monitoring and reporting system in South Korea,and comparing them with those in China,it was possible to provide reference for the construction of more effective pharmacovigilance systems in China by optimizing the functions of technical institutions for pharmacovigilance,improving the pharmacovigilance reporting system,and ensuring rational drug use.Results and conclusion According to the newly revised pharmaceutical law,South Korea established the Institute of Drug Safety and Risk Management,improved the monitoring and reporting system of pharmacovigilance.China should optimize the functions of technical institutions for pharmacovigilance,improve the reporting system of pharmacovigilance,and assess the rationality of drug use.

关 键 词：药物警戒 韩国 体系 药品不良反应 监测 

分 类 号：R994.11[医药卫生—毒理学] R951[医药卫生—药学]