Research report on guidance for the multi-regional clinical trials
ZHANG Xiao-fang
HUANG Dan
WANG Xiang-yu
CHEN Gang
YAO Chen
LI Jing
YUAN Lin
Abstract：With the globalization of drug development,more attention is paid on the multi-regional clinical trial (MRCT).The use of MRCT can expedite the simultaneous new drug development with more patient population sources,maintain a same level of scientific rigor in the trial design when the outcomes delivered to different regulatory agencies for evaluation and reduce unnecessary development cost.However,there are challenges and concerns with the use of MRCT to national drug regulation.Many countries,including China and the international organizations including ICH,have introduced their own provisions.This article compares MRCT regulatory requirements of US,EU and Japan,and introduces ICH related guidance and analyses of similarities and differences between ICH and China Food and Drug Administration guidance,with a view to inspire the supervision of the multi-regional clinical trial in China.
Keywords：multi-regional clinical trialICH E5ICH E9ICH E17regulatory requirements
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：7( 2052-2058 )