Interpretation and reflection on the Reg.(EU) No 536/2014 of the European
WEI Fen-fang
SUN Yu-xin
LENG Jin-nuo
YANG Yue
Abstract：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.
Keywords：EMAclinical trialsReg.(EU) No 536/2014
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：8( 1865-1872 )