The European Medicines Agency (EMA), together with the European Medicines Regulatory Network, has issued a renewed call for registrations in their Real-World Data (RWD) Catalogues, marking one year since the initiative’s launch.
This publicly accessible online resource replaced the previous ENCePP Resources Database and the EU PAS Register, consolidating metadata on RWD sources and studies to aid regulators, researchers, and pharmaceutical companies in assessing the real-world use, safety, and effectiveness of medicines.
EMA aims to build a comprehensive resource by encouraging stakeholders who manage data sources or who have conducted RWD studies to register their metadata. Participation not only increases visibility among regulators, researchers, and industry but also facilitates transparency and promotes collaboration in non-interventional research. Furthermore, registered data sources provide essential context for regulators, enabling more accurate interpretation of study results and potentially qualifying participants to become data partners of DARWIN EU.
The Catalogues support regulatory decisions and scientific research by allowing access to aggregated metadata rather than raw data itself. This approach ensures transparency and enhances the utility of RWD for rigorous regulatory assessments.
To register a data source or study, stakeholders can visit the Catalogue of RWD Sources or the Catalogue of RWD Studies. For further assistance, detailed guidance on the registration process is available on the Catalogues’ Support page. Questions can also be directed to EMA via email at RWDcatalogues@ema.europa.eu.
Photo by Daniel Foster via Flickr CC BY-NC 2.0
