ICH M4E Common technical document for the registration of pharmaceuticals for human use - efficacy

Current effective version

PDF iconRevision 2 - Adopted guideline

Reference numberEMA/CPMP/ICH/2887/1999
Published28/07/2016
Effective from31/01/2017
KeywordsCommon technical document (CTD), clinical data
DescriptionThis document provides detailed guidance on the information to be included in the clinical overview sections of the common technical document.


Document history

Revision 2

Current version

PDF iconAdopted guideline

PDF iconDraft guideline

Published: 28/07/2016

Published: 07/10/2015

First version PDF iconAdopted guideline In operation: 01/07/2003


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