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 1 - Adopted guidance

Reference numberEMA/90915/2016 Version 1.1
Published21/12/2016
Effective from21/12/2016
KeywordsClinical data publication, anonymisation of clinical reports, commercially confidential information (CCI), policy 0070, redaction proposals,
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 is revised periodically.


Document history

Revision 1
Current version

Adopted guidance


Summary of changes


 

In operation: 21/12/2016–present


Published: 21/12/2016


 

First version


 

Adopted guidance


 

In operation: 02/03/2016–20/12/2016


 


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