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

Current effective version

PDF icon Revision 2 - Adopted guideline

Reference numberEMA/CPMP/ICH/2887/1999
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 icon Adopted guideline

PDF icon Draft guideline

Published: 28/07/2016

Published: 07/10/2015

First version PDF icon Adopted guideline In operation: 01/07/2003

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