The HMA-EMA Catalogue of RWD studies replaces the European Union electronic register of post-authorisation studies (EU PAS Register®).

The Catalogue of RWD studies focuses on observational research, and its purpose is to:

  • increase transparency;

  • reduce publication bias;

  • promote the exchange of information and facilitate collaboration among stakeholders (including academia, sponsors and regulatory bodies);

  • ensure compliance with EU pharmacovigilance legislation requirements.


What type of studies should be added in the study catalogue?

  • Non-interventional post-authorisation safety studies (PASS)

These are imposed as an obligation for the marketing authorisation or a specific obligation in the context of a conditional marketing authorisation or marketing authorisation granted under exceptional circumstances.

EU pharmacovigilance legislation requires the European Medicines Agency (EMA) to make public the protocols and abstracts of results of non-interventional PASS imposed as an obligation of marketing authorisation by a competent authority in accordance with Article 10 or 10a of Regulation (EC) No 726/2004 or with Articles 21a or 22a of Directive 2001/83/EC. These should therefore be published on the Catalogues website by the Marketing Authorisation Holder (MAH).

  • Required non-interventional PASS

MAHs are encouraged to add to the Catalogue any PASS they initiated, managed and/or financed and which were required in a Risk Management Plan (RMP) to further investigate safety concerns or evaluate the effectiveness of risk minimisation activities. Further information about the requirements for the registration of these PASS is available in the guideline on Good Pharmacovigilance Practices (GVP) module VIII.

  • Any other real-world data (RWD) study conducted by MAHs, regulators, academia or research organisations

To support the same level of transparency, as well as scientific and quality standards, study sponsors (e.g., MAHs, regulators or research organisations) are encouraged to add study protocols and results/reports of any RWD study (not restricted to safety or post-authorisation) that is outside the scope of Regulation (EU) No 536/2014 (i.e., not a clinical trial).

Additional consideration

If there is doubt whether a study should be considered interventional or non-interventional, a FAQs is available to guide study sponsors and researchers intending to submit studies.