Launch of new HMA-EMA catalogues of real-world data sources and studies

EMA and the Heads of Medicines Agencies (HMA) have launched two public electronic catalogues:

• The catalogue for RWD sources : enhances and replaces the ENCePP Resources Database (an EMA-coordinated index of resources of available research organisations, networks and data sources in the fields of pharmacoepidemiology and pharmacovigilance within Europe).

• The catalogue for RWD studies : expands and replaces the European Union electronic register of post-authorisationstudies (EU PAS Register).

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.