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

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Current effective version

Revision 2 - Adopted guidance

Reference numberEMA/90915/2016 Version 1.2
Published12/04/2017
Effective from12/04/2017
KeywordsClinical data publication, anonymisation of clinical reports, commercially confidential information (CCI), policy 0070, redaction proposals, redaction proposal package checklist.
DescriptionThis 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 2
Current version

Adopted guidance


Summary of changes


 

In operation: 12/04/2017–present


Published: 12/04/2017


 
Revision 1
 

Adopted guidance

 

Summary of changes

In operation: 21/12/2016–11/04/2017

 

Published: 21/12/2016

 

First version


 

Adopted guidance


 

In operation: 02/03/2016–20/12/2016


 


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