The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have just launched two public electronic catalogues: one for real-world data (RWD) sources and another one for RWD studies.

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 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-authorisation studies (EU PAS Register®).

In addition, as part of this initiative, the ENCePP website has been renewed.

Using ‘FAIR’ data principles (Findable, Accessible, Interoperable and Reusable), these catalogues use an agreed set of metadata to describe and connect data sources to studies. Search on a wider set of metadata, enhanced view, export and data submission functionalities have been implemented in the catalogues.

These developments will help European patients receive better medicines faster and promote safe and effective use of the medicines on the market.

EMA will host a webinar on 4 March 2024 to provide an overview of the catalogues including their benefits and significance in regulatory practices. It will also explain how to use the catalogues, user roles and responsibilities effectively.

Discover more here!

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