美国FDA对药物临床试验的监管

FDA's administration of drug clinical trials

文中通过对FDA的生物研究试验监查体系(bioresearch monitoring program,BIMO)开展药物临床试验监查的法律法规依据、执行检查的相关机构、检查类型、检查流程和检查结果分类进行分析研究,得出FDA对药物临床试验的监管具备完善的法律法规依据、对药物临床试验的各参与方的检查全面深入、检查队伍专业、检查标准高,以期对我国药物临床试验的监管提供借鉴,从而全面提高我国药物临床试验的监管水平。

The legal basis for FDA＇s Bioresearch Monitoring Program （BIMO） to carry out drug clinical trial inspections, the performing organization, the types of inspections, the process of inspections and the results of inspections were summarized. The authors find out that the legal basis of FDA＇s drug clinical trial supervision is complete, the clinical trial inspection is thorough and complete, and the inspection team is professional with high standard. The author hopes that we can draw some experiences therefrom to improve the drug clinical trial administration standard in our country.