2008年至2015年欧盟药物临床试验检查情况分析

Analysis of good clinical practice inspections conducted by the European Union from 2008 to 2015

欧盟药物临床试验检查分为两类,分别为欧洲药品管理局实施的检查和欧盟各成员国实施的检查。欧洲药品管理局人用药品委员会负责对在欧盟按集中审评程序递交的上市许可药品所开展的临床试验实施检查。本文对2008年至2015年欧盟实施的药物临床试验检查情况进行了梳理,重点对检查中发现的缺陷进行了分类和分析,旨在为中国药物临床试验数据核查工作提供参考,为中国药物临床试验检查的质量提升提供借鉴。

Good clinical practice （GCP） inspections in the European Union are classified into two types, one conducted by the European Medicines Agency （EMA） and the other performed under national programmes. The Committee for Medicinal Products for Human Use （CHMP） of EMA is responsible for the inspections of clinical trials included in marketing authorization applications using the centralized procedure in the European Union. This paper classified and analyzed findings of GCP inspections conducted at the request of the European Union from 2008 to 2015, in order to provide information for GCP inspection in China as well as to improve the quality of GCP inspection.