News!

New functionality released!

Introducing a new feature to improve user experience in identifying, understanding and selecting data sources.

Now you can easily compare key characteristics across multiple data sources by selecting up to three data sources for a dynamic side-by-side comparison. This enhancement supports users more effectively in understanding data sources, their strengths and limitations against other data sources, as well as in identifying a suitable data source for a research question.

You can enable this feature by switching the filter 'Compare data sources' to "Yes" in page Search | HMA-EMA Catalogues of real-world data sources and studies

New field for uploading the Abstract of the final study report

A new change to support better tracking and visibility has been implemented in Studies that enables users to upload separately the Abstract of the final study report and the Final study report required by the EU Implementing Regulation 2025/1466 for non-interventional post-authorisation safety studies initiated, managed or financed by a marketing authorisation holder under obligations imposed by a national competent authority, the Agency or the Commission.

 

Aim of the HMA-EMA RWD Catalogues

The HMA-EMA RWD Catalogues are repositories of metadata collected from real-world data (RWD) sources and RWD studies. They are intended to help regulators, pharmaceutical companies and researchers to identify and use such data when investigating the use, safety and effectiveness of medicines.

The Catalogue of RWD sources replaced the ENCePP Resources Database, while the Catalogue of RWD studies replaced the EU PAS Register®. Additionally, Catalogues of institutions and networks are also available to support the RWD sources and RWD studies Catalogues. Together, these Catalogues offer an improved and more efficient service for researchers, regulators, and pharmaceutical companies to:

  • Facilitate the discoverability of adequate data sources to generate real-world evidence for regulatory purposes (e.g., identification of RWD data sources suitable for investigating a specific research question);
  • Aid in the suitability assessment of data sources by providing clear and easy access to information from the study protocol and study report;
  • Improve interoperability between studies and data sources;
  • Improve transparency.

The catalogues are fully searchable and the data available in the registered entities can be exported. 

Important note for record owners

Records that were previously published in the ENCePP Resources Database or the EU PAS Register (data sources, networks, institutions, or studies) have been migrated to the RWD Catalogues. To claim a migrated record:

  1. Create an EU Login account if you do not have one by following these steps: EU LOGIN (europa.eu). 
  2. Log into the RWD Catalogues using your EU Login account details. Logging into the RWD Catalogues for the first time is a necessary step to complete the record assignment process.
  3. Raise a ticket via EMA Service Desk (ServiceNow). You can find detailed information on how to raise a ticket on this page: Contact us | HMA-EMA Catalogues of real-world data sources and studies.