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

This document provides detailed guidance on the information to be included in the clinical overview sections of the common technical document.

Keywords: Common technical document (CTD), clinical data

Current effective version

ICH M4E (R2) Common technical document for the registration of pharmaceuticals for human use - efficacy - Step 5

Adopted Reference Number: EMA/CPMP/ICH/2887/1999 Legal effective date: 31/01/2017 Summary:

The Clinical Overview is intended to provide a critical analysis of the clinical data in the Common Technical Document. The Clinical Overview will necessarily refer to application data provided in the comprehensive Clinical Summary, the individual clinical study reports (ICH E3), and other relevant reports; but it should primarily present the conclusions and implications of those data, and should not recapitulate them.

Document history

Draft M4E(R2) Common technical document for the registration of pharmaceuticals for human use – efficacy - Step 3

Adopted Consultation dates: 07/10/2015 to 31/12/2015 Reference Number: EMA/CPMP/ICH/2887/1999 Legal effective date: 31/01/2017 Summary:

The clinical overview is intended to provide a critical analysis of the clinical data in the common technical document. The clinical overview will necessarily refer to application data provided in the comprehensive clinical summary, the individual clinical study reports (ICH E3), and other relevant reports; but it should primarily present the conclusions and implications of those data, and should not recapitulate them.

ICH: M 4 E: Common technical document for the registration of pharmaceuticals for human use - Efficacy - Step 5

Adopted Reference Number: CPMP/ICH/2887/99 Legal effective date: 01/07/2003