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