RWD Catalogues

The HMA-EMA 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 replaces the ENCePP Resources Database, while the Catalogue of RWD studies replaces 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** 

  1. If you do not yet have an EU Login account, please follow the steps to create an EU Login account: EU LOGIN (europa.eu)
  2. Please be aware that it is only possible to access your records previously published in the ENCePP Resource Database or the EU PAS Register (data source, network, institution, or studies) within the RWD Catalogues if you have completed the survey: https://ec.europa.eu/eusurvey/runner/EMA-HMA_Catalogues
  3. If you have already claimed your record in the survey, please proceed to log in to the Catalogues website. Logging in for the first time is a necessary step in order for us to assign your claimed record(s) to your user account. EMA will continuously be assigning records to their owners in the period following the launch of the Catalogues. You may therefore experience some delay before obtaining access to your record(s) (~2 working days). 

Thank you for your understanding during this transition period. 

If you have followed the above steps and are still experiencing issues locating or accessing your records, please contact us.

 

Key improvements

The RWD Catalogues showcase significant enhancements in user experience and functionality, adhering to 'FAIR' (Findable, Accessible, Interoperable and Reusable) data principles. The Catalogues implement globally unique and persistent identifiers, ensuring data accessibility and interoperability. 

Improvements include:

  • Link between data sources and associated studies; 
  • Search and export functionalities have been improved, providing users with a more efficient and tailored exploration of the catalogue content;
  • Studies documents can be downloaded directly;
  • Enhanced security through EU Login authentication service from the European Commission;
  • Possibility to support collaborative efforts, enabling users to add co-authors for each record, fostering a collaborative and dynamic research environment.