欧盟临床试验网站的发展和现状  

Development and the current status of the European Union Clinical Trials Register

作　　者：王玉珠[1] 王利华[1] 张晓东[1] 黄清竹[1] 刘晓钰[1] 黄钦[1] 

机构地区：[1]国家食品药品监督管理总局药品审评中心,北京100038

出　　处：《中国临床药理学杂志》2014年第9期830-832,共3页The Chinese Journal of Clinical Pharmacology

摘　　要：2012-11,国家药品审评中心发布"药物临床试验登记与信息公示平台"试行版,并于2013-11进行了一次重要升级。其登记和公示的要求和内容等均基于对国际上先进临床试验网站的调研基础之上,包括欧盟临床试验网站(EU CTR)等。本文简要介绍EU CTR的建立、法规沿革以及登记和审核等相关内容,以帮助读者清晰认知这些问题,深入理解我国建设"药物临床试验登记与信息公示平台"的意义。In November 2012,Center for Drug Evaluation addressed the pilot version of ＂Platform for Registry and Publicity of Drug Clinical Trials＂,which has been updated in November,2013. The requirements for registry and publicity are on the basis of numerous surveys on advanced international clinical trials websites including the European Union Clinical Trials Register（ EU CTR）. This article briefly introduces the international background while building of EU CTR,its legislation reform,registration and check,etc,to help readers get a clear awareness and understand the significance of China Platform.

关 键 词：临床试验注册 药物临床试验登记与信息公示平台 欧盟临床试验网站 

分 类 号：R954[医药卫生—药学]