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

  • Email
  • Help
Current effective version

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

Adopted guideline 


Draft guideline

Published: 28/07/2016 


Published: 07/10/2015

First versionAdopted guidelineIn operation: 01/07/2003

Related content

How helpful is this page?

Average rating:

 Based on 20 ratings

Add your rating:

See all ratings
4 ratings
4 ratings
4 ratings
4 ratings
4 ratings

Tell us more