药物临床试验期间安全性数据快速报告的更新与思考  

Updates and reflections on expedited reporting of safety information during drug clinical trials

作　　者：刘敏 陈艳 刘文东 王海学 LIU Min;CHEN Yan;LIU Wendong;WANG Haixue(Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100076

出　　处：《中国药物警戒》2024年第1期98-101,106,共5页Chinese Journal of Pharmacovigilance

基　　金：国家科技重大专项重大新药创制(2015ZX09501008)。

摘　　要：目的增强业界对安全性信息快速报告实施要求的进一步理解。方法对《药物临床试验期间安全性数据快速报告常见问答(2.0版)》修订背景信息与变化进行解读分析,包括快速报告范围、时限、方式等。结果与结论为更好地提升安全性信息报告质量,药品注册申请人作为主体责任人要履行责任,积极与临床试验各参与方沟通交流,尽可能全面收集信息;药品监管机构应继续提升临床试验期间药物警戒监管能力和水平,完善标准体系建设和操作规范,加强风险评估能力,提高信息化水平,切实保护受试者的安全和权益。Objective To advance our understanding of the requirements on implementation of expedited reporting of safety information.Methods The background and changes of FAQ 2.0,including the scope,time limit,and method of expedited reporting,were interpreted and analyzed.Results and Conclusion In order to improve the quality of safety information reports,the applicant,as the main responsible person,should fulfil his responsibility,communicate willingly with all the parties involved in the clinical trial,and collect as much information as possible.The drug regulatory authority should continue to elevate the level of pharmacovigilance during the clinical trial,improve the system of standards and codes for practice,enhance the ability to assess risks,and upgrade informatization so as to protect the safety,rights and interests of the subjects.

关 键 词：临床试验 药品监管部门 药品注册 申请人 药物警戒 安全性 快速报告 

分 类 号：R951[医药卫生—药学] R994.11