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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: one for real-world data (RWD) sources and one for RWD studies.
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The catalogues help medicines regulators, researchers and pharmaceutical companies to identify the most suitable data sources to address specific research questions and support the assessment of study protocols and results. They aim to promote transparency, encourage the use of good practices, and build trust in research based on RWD.

The initiative builds on more than 15 years of operation of the former databases, developed by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP):

  • 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®).

As part of this initiative, the ENCePP website has been renewed. While some data sources and all centres and networks have migrated to the new catalogues replacing the ENCePP Resource Database, other content, such as ENCePP Guide on Methodological Standards in Pharmacoepidemiology and the ENCePP Code of Conduct, will remain available on the renewed ENCePP website.

The catalogues introduce various improvements to the previous ones. Using ‘FAIR’ data principles (Findable, Accessible, Interoperable and Reusable), they use an agreed set of metadata to describe and connect data sources to studies. It is based on the list of metadata published by the HMA-EMA Big Data Steering group in May 2022. A revised list will be published soon.

In addition, search on a wider set of metadata, enhanced view, export and data submission functionalities have been implemented in the catalogues.

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.

All European data holders, marketing authorisation holders, networks, researchers, and institutions who are interested in having their data used for medicines regulation or are obligated by policy on non-interventional post-authorisation safety studies (PASS), are encouraged to use these catalogues.

Notes

EMA will host a webinar on the catalogues on 4 March 2024 from 10:00 to 12:00 CET.

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