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

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.

Keywords: Clinical data publication, anonymisation of clinical reports, commercially confidential information (CCI), policy 0070, redaction proposals, redaction proposal package checklist

Current effective version

External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use - Version 1.4

AdoptedReference Number: EMA/90915/2016 Version 1.4

Document history - Revision 4 (current)

External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use - Version 1.4

AdoptedReference Number: EMA/90915/2016 Version 1.4

Summary of changes to the ‘External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use’ - Version 1.4

AdoptedReference Number: EMA/482146/2018

Document history - Revision 3

External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use - Version 1.3

AdoptedReference Number: EMA/90915/2016Summary:

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.

Summary of changes to the ‘External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use’ - Version 1.3

Reference Number: EMA/456715/2017

Document history - Revision 2

External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use - Version 1.2

AdoptedReference Number: EMA/90915/2016Summary:

The European Medicines Agency policy on the publication of clinical data for medicinal products for human use1 (hereafter referred to as ‘Policy 0070’) was developed by the European Medicines Agency (EMA), in accordance with Article 80 of Regulation (EC) No 726/2004. Policy 0070 was adopted by the EMA Management Board on 2nd October 2014 and subsequently published on the EMA website.

Summary of changes to the ‘External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use’ - Version 1.2

Reference Number: EMA/243680/2017

Document history - Revision 1

External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use - Version 1.1

Reference Number: EMA/90915/2016

Summary of changes to the ‘External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use’ - Version 1.1

Reference Number: EMA/729722/2016

Document history - First version

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

Reference Number: EMA/90915/2016