国际与国内药物临床试验质量管理规范比较分析  

Comparison of Domestic and International Good Clinical Practice Administration

作　　者：彭朋[1] 元唯安[1] 胡薏慧[1] 汤洁[1] 朱蕾蕾[1] 蒋健[1] 

机构地区：[1]上海中医药大学曙光医院国家药物临床试验机构,上海201203

出　　处：《解放军医院管理杂志》2015年第9期836-838,共3页Hospital Administration Journal of Chinese People's Liberation Army

基　　金：国家"重大新药创制"科技重大专项创新药物研究开发技术平台建设(2012ZX09303009-001)

摘　　要：目的阐明人用药物注册技术要求国际协调会议药物临床试验质量管理规范(ICH-GCP)和国家食品药品监督管理局药物临床试验质量管理规范(SFDA-GCP)的区别,并提出针对我国药物临床试验现状的建议。方法从术语解释、临床试验准入条件、伦理委员会、研究者、申办者和监查员的角度分析ICH-GCP和SFDA-GCP之间的差异,并探讨对我国药物临床试验相应的建议。结果我国药物临床研究水平与国际先进水平还有一定差距,临床试验实践过程中应该汲取ICH-GCP和SFDA-GCP两者的优势,完善国内法规。结论 ICH-GCP是全球范围内实施药物临床试验的主要质量标准,而通过不断学习ICH-GCP,将有助于我国药物临床试验在法规层面与国际接轨,提高临床试验质量。Objective To elucidate the distinction between good clinical practice from International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use and that from State Food and Drug Administration, and give suggestions for the status quo of drug clinical trials in China. Methods The difference between ICH - GCP and SFDA - GCP was analyzed from the aspects of term explanation, clinical trial access conditions, ethics committees, investigators, sponsors and monitors. The corresponding strategies on drug clinical trials in China were illustrated. Results At present, there is of certain disparity between the clinical research level in China and international advanced level. In clinical trial practice, the advantages of both ICH - GCP and SFDA - GCP should be taken to improve domestic legislation. Conclusion ICH - GCP is the principal quality standard of clinical trials around the world. It is favorable to correspond to international standards in the regulatory level via learning ICH - GCP persistently, which may enhance the quality of clinical trials.

关 键 词：临床试验 药物临床试验质量管理规范 人用药物注册技术要求国际协调会议 

分 类 号：R197.32[医药卫生—卫生事业管理]