Summary of changes to the guidance of publication of clinical trial data by EMA

On 03 March 2016, the European Medicines Agency published the ‘External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use’ (Policy 0070). Additional information that has been included in the guidance published on 12 April 2017 is outlined in the table below, including the location within the document with a summary of the additional information provided.