美国食品和药物管理局对临床试验申办者现场核查情况分析  

Analysis of situation about United State Food and Drug Administration' s GCP inspection of sponsor

作　　者：高敏洁[1] 

机构地区：[1]上海市食品药品监督管理局认证审评中心,上海200020

出　　处：《中国新药与临床杂志》2016年第3期185-189,共5页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的为加强和促进对我国药物临床试验申办者的监管提供借鉴。方法收集美国食品和药物管理局(FDA)网站上公布的生物研究监查(BIMO)项目2007—2014财政年度工作情况报告、科学调查办公室(OSI)工作情况更新报告及FDA 2010—2016财政年度预算报告中相关数据,分析FDA对临床试验申办者现场核查的比例、结果分级及FDA对药物临床试验核查的情况等。结果 2007—2011财政年度,FDA对临床试验申办者的现场核查比例逐年上升,自2012年降至中间水平后呈现平稳波动,同时自2009年起FDA对此类核查中发现的问题采取官方行动的比例明显下降。FDA药品审评和研究中心(CDER)组织实施的药物临床试验核查数量超过BIMO项目各中心GCP核查总数的一半,其未对所有新药申请和生物制品许可申请的申办者进行现场核查,受委托承担部分申办者职责的合同研究组织(CRO)亦是此类核查的重要内容。结论针对申办者的现场核查是药物临床试验监管的重要组成部分,借鉴国外成熟的监管经验建立符合我国国情的药物临床试验申办者和CRO的监管制度并开展相关的现场核查势在必行。AIM To provide experiences and references for enhancing the oversight of sponsors in domestic drug clinical trials. METHODS The data published in United States Food and Drug Administration （FDA） website were collected, including bioresearch monitoring （BIMO） metrics from fiscal year （FY） 2007 to 2014, Office of Scientific Investigations （OSI） metrics and FDA justification of estimates for appropriations committees from FY 2010 to 2016. The situation, such as the proportion, classifications of FDA＇ s good clinical practice （GCP） inspections of sponsors, and the situation of FDA＇ s GCP inspections for drug clinical trials were analyzed. RESULTS From FY 2007 to 2011, the proportion of FDA＇ s GCP inspections of sponsors had increased year by year, till 2012 the number decreased to the middle level and has smoothly fluctuated. Meanwhile the percentage of official action indicated （OAI） classification for this type of inspection has declined from 2009. FDA＇ s Center for Drug Evaluation and Research （CDER） arranged more than half of all the BIMO GCP inspections. Not all the new drug application/biologics license application （NDA/BLA） sponsors overseen by CDER were inspected. The contract research organizations （CRO） who took the transferred sponsor＇s responsibilities also were the important part of the inspections. CONCLUSION Sponsor inspection is the important part of the oversight of drug clinical trials. The rules that adapt to China for overseeing the sponsors/ CRO of domestic drug clinical trials ought to be established through absorbing the mature experiences from the advanced countries and the relevant inspections shall be conducted appropriately.

关 键 词：美国食品和药物管理局 临床试验 政府调控 申办者 现场核查 

分 类 号：R95[医药卫生—药学]