摘要
2016年欧盟临床试验法规取代了欧盟临床试验指令。Reg.(EU)No 536/2014代表了欧盟临床研究政策环境的又一个重要里程碑。然而,Reg.(EU)No 536/2014仍然存在一定的阻碍,需要监管者和申办者共同解决。本文介绍了Reg.(EU)No 536/2014的颁布背景,着重分析Reg.(EU)No 536/2014条款的重大变化,并对其进行解读与思考,以期为完善我国药物临床试验法律体系提供参考。
The European Union Clinical Trial Directive was replaced by the European Union Clinical Trials Act in 2016. Reg. (EU) No 536/2014 represents another important milestone in the policy environment for clinical research in the EU. However, Reg. (EU) No 536/2014 still exists some deterrents that require regulators and sponsors to work together with. This article describes Reg. (EU) No 536/2014, focusing on analysis of the major changes, and analyzes and ponders them so as to provide reference for improving the legal system of drug clinical trials in China.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2017年第16期1865-1872,共8页
Chinese Journal of New Drugs