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The EMA has published a list of metadata for Real World Data (RWD) directories

🔷New HMA-EMA catalogues of Real World Data sources and studies have been launched.


🔷The catalogues are intended to help medicines regulators, researchers and pharmaceutical companies select the optimal data sources of a data source to answer specific research questions, and to support the evaluation of study protocols and results.


🔷The aim of the directories is to promote transparency, encourage good practice and build trust in RWD-based research.


➤The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance website has been renewed. The RWD resource directory expands and replaces the ENCePP resource database, an EMA-coordinated index of available research organisations, networks and data sources in the field of pharmacoepidemiology and pharmacovigilance in Europe. The RWD study catalogue extends and replaces the European Union's electronic register of post-marketing studies (EU PAS Register®).


🔷Searching based on a wider set of metadata, improved browsing, export and upload functions 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 data discoverability is one of the priorities identified in the final report of the HMA-EMA Joint Task Force on Big Data (Phase 2), reflected in the European Medicines Agency Network Strategy 2025 and implemented as part of the HMA-EMA Joint Steering Group Big Data work plan. Ultimately, these changes will help European patients receive better medicines faster and promote the safe and effective use of medicines on the market.


The new catalogues are available at:

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