EMA RELEASES GUIDANCE ON CLINICAL DATA PUBLICATION GUIDANCE
March 1st, 2016
The European Medicines Agency (EMA) has published detailed guidance on how pharmacos can comply with its new policies on publishing clinical data. They came into force January 2015 and apply to clinical reports contained in all marketing-authorisation applications submitted from this date. The first release of such reports is planned for this September (2016). The guidance explains legal definitions and procedures for submitting clinical reports. It also advises companies on anonymising clinical reports for publication, balancing data utility for researchers and ...
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