摘要
2019年新修订的《药品管理法》明确国家建立药物警戒制度,国家药监局也陆续发布了《药物警戒质量管理规范》《药物警戒检查指导原则》等法规文件,为药品上市许可持有人落实药物警戒主体责任提供了明确的标准和操作指南。2020年,山东省依据《药品不良反应报告和监测管理办法》《药品不良反应报告和监测检查指南(试行)》等要求,对辖区51家药品上市许可持有人药品不良反应报告和监测工作情况进行了检查。本文通过对检查发现的问题、缺陷情况进行分析,探讨持有人在药品不良反应报告和监测工作基础上,开展药物警戒工作存在的主要问题和困难,提出推动持有人落实药物警戒主体责任、加强药物警戒工作的相关建议。
The newly-revised Drug Administration Law of the People’s Republic of China stipulates that the State shall establish a pharmacovigilance system.Subsequently,the National Medical Products Administration has issued regulations and documents such as the Good Pharmacovigilance Practices and the Guidelines on Pharmacovigilance Inspection,which provide clear standards and operation guidelines for marketing authorization holders(MAH)to take their primary responsibility for pharmacovigilance.In 2020,Shandong province inspected the adverse drug reaction(ADR)reporting and monitoring of 51 MAHs under its jurisdiction in accordance with the Provisions on Adverse Drug Reaction Reporting and Monitoring and the Guidelines on Inspection of Adverse Drug Reaction Reporting and Monitoring(Interim).Based on analysis of the problems and defects found during these inspections,this paper discusses the main problems and difficulties faced by MAHs in carrying out pharmacovigilance tasks on the basis of ADR reporting and monitoring,and proposes relevant suggestions for motivating MAHs to take primary responsibility for pharmacovigilance and thereby strengthening pharmacovigilance.
作者
张华琦
路长飞
崔小康
刘文文
高文政
李霞
ZHANG Hua-qi;LU Chang-fei;CUI Xiao-kang;LIU Wen-wen;GAO Wen-zheng;LI Xia(Shandong Center for Adverse Drug Reaction Monitoring)
出处
《中国食品药品监管》
2022年第5期100-107,共8页
China Food & Drug Administration Magazine
关键词
药品上市许可持有人
药品不良反应
药物警戒
检查
分析
marketing authorization holder
adverse drug reaction
pharmacovigilance
inspection
analysis
