ICH guideline E17 on general principles for planning and design of multi-regional clinical trials

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Current effective version

Adopted guideline

Adopted guideline enters into effect 14/06/2018

Reference numberEMA/CHMP/ICH/453276/2016
Effective from14/06/2018
KeywordsMRCT , multiregional, clinical trials, confirmatory trials, exploratory trials
DescriptionThe purpose of this document is to outline general principles for the planning and design of multiregional clinical trials with the aim of increasing their acceptability in global regulatory submissions. The document addresses some strategic programme issues as well as aspects specific to the planning and design of confirmatory MRCTs and should be used together with other ICH efficacy guidelines, including E2, E3, E4, E5, E6, E8, E9, E10 and E18.

Document history

First version

Current version

Adopted guideline


Overview of comments


Draft guideline

Published: 18/12/2017
Effective from: 14/06/2018


Published: 13/02/2017


Published: 28/07/2016

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