|Current effective version|
|Reference number||EMA/90915/2016 Version 1.1|
|Keywords||Clinical data publication, anonymisation of clinical reports, commercially confidential information (CCI), policy 0070, redaction proposals,|
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.
In operation: 21/12/2016–present
In operation: 02/03/2016–20/12/2016
Related content for human medicines
- European Medicines Agency policy on publication of clinical data for medicinal products for human use
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- Support for industry on clinical data publication
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