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) conducted pursuant to an obligation imposed by an EU competent authority

These are non-interventional PASS 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 Catalogue of RWD studies by the Marketing Authorisation Holder (MAH).

  • Other non-interventional PASS

It is highly recommended that MAHs add to the Catalogue any non-interventional PASS they initiated, managed and/or financed which were required in a Risk Management Plan (RMP) to further investigate safety concerns or evaluate the effectiveness of risk minimisation activities, or conducted voluntarily in the EU. 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 register any RWD study (not restricted to safety or post-authorisation) and add study protocols and results/reports.