药物临床试验登记与信息公示平台介绍及常见问题分析  

Introducing the platform for registry and publicity of drug clinical trials and analyzing the common questions in trial registry

作　　者：黄钦[1] 王玉珠[1] 范乙[1] 刘晓钰[1] 高荣信 

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：《中国新药杂志》2014年第23期2721-2724,共4页Chinese Journal of New Drugs

基　　金：国家"重大新药创制"科技重大专项(2011ZX09304-01)

摘　　要：2013年9月6日,国家食品药品监督管理总局发布第28号《关于药物临床试验信息平台的公告》,要求所有获其批准的药物临床试验均需在药品审评中心搭建的"药物临床试验登记与信息公示平台"上登记和公示信息。这一要求是监管部门遵照国际惯例加强药物临床试验监督管理,推进药物临床试验信息公开透明,保护受试者权益与安全的一项重要举措。本文对该平台的设计思路及搭建过程予以介绍,并针对广大登记人在应用平台登记试验过程中遇到的常见问题进行答复说明,以利于帮助登记人更好地理解和做好这项工作。On September 6th 2013, China Food and Drug Administration（CFDA） issued the 28th notifica- tion requiring. It was required that all drug clinical trials approved by CFDA must be registered and made public on the registry and publicity platform. The platform for registry and publicity of drug clinical trials was established by Center for Drug Evaluation. This requirement in accordance with international practice is an important initiative for regulatory agency to enhance the supervision and management of drug clinical trials, promote the openness and transparency of drug clinical trial information, and protect the interests and safety of subjects. The paper will introduce the building process and design thoughts of the platform, and reply the common problems in the registration process, in order to help registrants better understand it and fulfill this work.

关 键 词：药物 临床试验 登记 公示 

分 类 号：R95[医药卫生—药学]