EMA and HMA Launch Real-Word Data Catalogues

28 February 2024

Susan Haigney / BioPharm International

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) announced on Feb. 15, 2024 that they have launched two public electronic catalogues for real-word data (RWD). The RWD catalogues will help regulators, researchers, and pharmaceutical companies identify suitable data sources for research and assessment of study protocols and results.

Created to promote transparency, encourage good practices, and build trust in RWD, the catalogues build on former databases developed by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). The RWD sources catalogue replaces the ENCePP Resources Database. The RWD studies catalogue replaces the European Union electronic register of post-authorization studies. The ENCePP website has been renewed. Data sources, centers, and networks have migrated to the new catalogues; however, some content will remain on the renewed ENCePP website.

Improvements over the previous databases have been included in the new catalogues. An agreed set of metadata have been used to describe and connect data sources to studies, based on a list of metadata published by the HMA-EMA Big Data Steering group in May 2022. Functionalities have been implemented such as a wider set of metadata, enhanced view, and export and data submissions.

“The publication of the RWD catalogues brings the European medicines regulatory network closer to more data-driven regulation. Improving discoverability of data is one of the priorities set in the HMA-EMA joint Big Data Task Force final report (phase two), reflected in the European medicines agencies network strategy to 2025 and implemented through the joint HMA-EMA Big Data Steering Group workplan. Ultimately, these developments will help European patients receive better medicines faster and promote safe and effective use of the medicines on the market,” EMA stated in a press release.



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