EMA Policy on the Publication of Clinical Data

Sponsors and marketing authorization holders (MAHs) in Europe have the option, to a certain extent, of marking the data and information they submit as not intended for the public and informing the EMA accordingly. To this end, the EMA has developed detailed guidelines for pharmaceutical companies on the requirements for compliance with its guidelines on the publication of clinical data.

The EMA has published a revised Version 1.5 of the guideline on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use. Due to the extensive updates in all chapters of the guideline, the EMA has simultaneously published a summary of the revised content in this guideline as an aid for the healthcare professionals concerned and to present the changes.

The EMA has set up a dedicated website regarding the publication of clinical study data, where further information can be found. For more details please see the "External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use".