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?

 
Any real-world data (RWD) study conducted by MAHs, regulators, academia or research organisations (not restricted to safety or post-authorisation research questions) and conducted in any geography

 

Please also upload study protocols and results/reports. In particular:

  • 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 publish protocols and result summaries for these studies. Marketing Authorisation Holders (MAH) must upload them to the Catalogue in line with:

    • Regulation (EC) No 726/2004 (Article 10 or 10a)

    • of Directive 2001/83/EC (Articles 21a or 22a)

       

  • Other non-interventional PASS

    MAHs are highly recommended to 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.