Following the successful transition of the ENCePP Resources Database and EU PAS Register to the HMA-EMA Catalogues of RWD sources and studies, EMA’s goal is to make the Catalogue of RWD sources a central, comprehensive repository containing metadata information from as many data sources as possible across Europe and beyond.
By increasing the number of registered data sources, the aim is to:
- Increase the possibility of identifying relevant data sources as suitable sources for non-interventional studies, and promote collaborations and utilisation of the most appropriate data source(s) in such studies;
- Enhance the visibility of available data sources, making them known to regulators, researchers, and pharmaceutical companies;
- Allow regulators to better interpret study results based on specific data sources as part of a regulatory procedure;
- Link the data sources to studies registered in the Catalogue of RWD studies which have utilised these data sources and therefore promote transparency in observational research;
- Provide an opportunity to apply to become a data partner for DARWIN EU via the Catalogues.
Data holders can add information about their data source directly in the Catalogues following this link: Catalogue of RWD sources or by sending an email to RWDcataloguesema [dot] europa [dot] eu (RWDcatalogues[at]ema[dot]europa[dot]eu).
Detailed information on how to create a data source record can be found on the Support page. The metadata collected for data sources can be found here: Data Source_Questionnaire.
Your feedback is important
The EMA's RWD Catalogue team value your feedback and insights on future improvements that could enhance the Catalogues' usability. Please share your ideas by emailing the team at RWDcataloguesema [dot] europa [dot] eu (RWDcatalogues[at]ema[dot]europa[dot]eu).
Details
- Publication date
- 17 July 2024
- Author
- European Medicines Agency