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
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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 (PDF/1.27 MB)
Adopted
First published: 09/11/2018
EMA/90915/2016 Version 1.4 -
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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 (PDF/86.01 KB)
Adopted
First published: 09/11/2018
EMA/482146/2018
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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 (PDF/1.46 MB)
Adopted
First published: 22/09/2017
Last updated: 22/09/2017
EMA/90915/2016 -
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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 (PDF/217.35 KB)
First published: 22/09/2017
Last updated: 22/09/2017
EMA/456715/2017
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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 (PDF/1.18 MB)
Adopted
First published: 12/04/2017
Last updated: 12/04/2017
EMA/90915/2016 -
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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 (PDF/130.03 KB)
First published: 12/04/2017
Last updated: 12/04/2017
EMA/243680/2017
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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 (PDF/1.16 MB)
First published: 20/12/2016
Last updated: 20/12/2016
EMA/90915/2016 -
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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 (PDF/97.31 KB)
First published: 09/12/2016
Last updated: 09/12/2016
EMA/729722/2016