欧美生物等效性试验现场检查启动因素的对比分析  

Comparative analysis on triggers for inspections of bioequivalence trials in European Medicines Agency and Food and Drug Administration

作　　者：陈方 李源 李敏 余珊珊 高磊 李艳蓉 赵明 CHEN Fang;LI Yuan;LI Min;YU Shan-shan;Gao Lei;LI Yan-rong;ZHAO Ming(Center for Drug Evaluation,National Medical Products Administration,Beijing,100061,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100061

出　　处：《中国临床药理学杂志》2020年第20期3383-3386,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：近些年来,各国药监机构陆续在临床试验监管中实施风险管理。基于风险的临床试验监管更聚焦于临床试验的关键过程及可能出现的重大风险,是一种科学监管模式的探索。本文对欧美生物等效性试验现场检查启动的风险因素进行总结分析,以期为国内开展基于风险的临床试验数据核查工作提供参考,不断提高临床试验数据核查的质量和效率。同时,希望临床试验的各参与方不断提升临床试验的水平和申报资料的质量,保证药物临床试验的合规性和数据的质量。In recent years,some drug regulatory agencies,one after another,have been implementing the risk-based clinical trial supervision,which is more focusing on the key processes and potential critical risks in clinical trials and is a scientific supervision mode.We summarized the triggers for inspections of BE trials in EMA and FDA for reference of the domestic clinical trials inspections in order to increase the quality and efficiency of clinical trials inspections.Furthermore,hope the parties involved in clinical trials to guarantee the compliance and data integrity of clinical trials by continuously improving the level of clinical trials and the quality of drug registration application dossiers.

关 键 词：现场检查 药物临床试验质量管理规范 风险管理 生物等效性试验 

分 类 号：R95[医药卫生—药学]