News! New functionalities released

The following new functionalities are now available:

  • Updated structure of study records: A new tab called “Resources” is now available where all study related documents (e.g., protocol, results) are grouped together for improved findability. Study owners will be able to find the already uploaded documents under this tab.
  • Study protocols:
    • All versions of the protocol will now be visible under the “Updated protocol” section on the Resources tab.
    • Study owners will not be able to amend already uploaded protocol documents but only upload a new version. If a document has been inadvertently uploaded, users can request its replacement by contacting us at EMA Service Desk (ServiceNow).
  • New search filters:
    • Data source search: You can now filter for population age groups and data source collection time span.
    • Study search: You can now filter for study population age groups, special populations (e.g., pregnant women), and non-interventional study design.

  • PASS linked under EMA medicines page: It is now possible to access RWD studies published in the Catalogues via the EMA corporate website for centrally authorised medicines. This linkage, visible on the EMA medicines page, enables you to quickly access relevant PASS for the medicine(s) in question.

     

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.