欧美日和中国药品风险管理概述  

Overview of Drug Risk Management in European Union,the United States,Japan and China

作　　者：梁笑笑 吕淑贤 李晓[3] 崔学艳[3] 张霈 黄欣 LIANG Xiaoxiao;LYU Shuxian;LI Xiao;CUI Xueyan;ZHANG Pei;HUANG Xin(School of Pharmacy,Shandong University of Traditional Chinese Medicine,Jinan,Shandong,China 250355;School of Pharmacy,Shandong First Medical University,Jinan,Shandong,China 250000;The First Affiliated Hospital of Shandong First Medical University·Shandong Provincial Qianfoshan Hospital,Jinan,Shandong,China 250014)

机构地区：[1]山东中医药大学药学院,山东济南250355 [2]山东第一医科大学药学院,山东济南250000 [3]山东第一医科大学第一附属医院·山东省千佛山医院,山东济南250014

出　　处：《中国药业》2023年第3期16-21,共6页China Pharmaceuticals

基　　金：中国毒理学会临床毒理专项(2020年度)课题[CST2020CT104];北京北方医药健康经济研究中心项目[DRM2021008]。

摘　　要：目的为中国实施药品风险管理提供参考。方法计算机检索中国知网、万方、维普及PubMed,EMBase,Web of Science数据库中关于药品风险管理的文献,以及美国食品和药物管理局(FDA)、欧洲药品管理局(EMA)、日本医药品医疗器械综合机构(PMDA)和国家药品监督管理局(NMPA)官网的相关内容,时间为自建库起至2022年6月10日。归纳总结药品风险管理的概况、组成与发展。结果美国、欧盟和日本均已形成较成熟的药品风险管理体系,中国的药品风险管理正处于快速发展阶段。结论借鉴欧盟、美国、日本成熟的药品风险管理体系,完善、推动中国药品风险管理体系建设与落地实施。Objective To provide a reference for the implementation of drug risk management in China.Methods The studies related to the drug risk management in the CNKI,WanFang,VIP,PubMed,EMBase and Web of Science databases,as well as the relevant content in the Food and Drug Administration(FDA),the European Medicines Agency(EMA),the Pharmaceuticals and Medical Devices Agency(PMDA)and the National Medical Products Administration(NMPA)official websites from the inception to June 10,2022 were searched,and the overview,composition and development of drug risk management was summarized.Results The drug risk management system had been developed relatively mature in the United States,European Union and Japan,and it was in the rapid development period in China.Conclusion By studying the mature drug risk management system in the European Union,the United States and Japan,we can improve and promote its construction and implementation in China.

关 键 词：药品风险管理 美国 欧洲联盟 日本 风险评估与减低策略 药品风险管理计划 

分 类 号：R95[医药卫生—药学]