External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use

Current effective version

PDF iconRevision 3 - Adopted guidance

Reference number EMA/90915/2016 Version 1.3
Published 22/09/2017
Effective from 22/09/2017
Keywords Clinical data publication, anonymisation of clinical reports, commercially confidential information (CCI), policy 0070, redaction proposals, redaction proposal package checklist.
Description This document provides guidance to industry on practical aspects of the implementation of the Agency's policy on the publication of clinical data for medicinal products for human use. It covers guidance on the procedural aspects of the submission of clinical reports, the anonymisation of clinical reports and the identification and redaction of commercially confidential information in clinical reports. It also includes a checklist for the 'Redaction Proposal Document' package. This guidance is revised periodically.


Document history

Revision 3
Current version

PDF iconAdopted guidance

 

PDF iconSummary of changes

In operation: 22/09/2017–present

 

Published: 22/09/2017

Revision 2

PDF iconAdopted guidance

 

PDF iconSummary of changes

In operation: 12/04/2017–21/09/2017

 

Published: 12/04/2017

Revision 1

PDF iconAdopted guidance

 

PDF iconSummary of changes

In operation: 21/12/2016–11/04/2017

 

Published: 21/12/2016

 

First version

PDF iconAdopted guidance

 

 

In operation: 02/03/2016–20/12/2016

 

 

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