EMA invites data holders to contribute to the Catalogue of RWD sources

The Heads of Medicines Agencies–European Medicines Agency initiative invites data holders to register real-world data (RWD) sources, creating a comprehensive repository to facilitate real-world evidence (RWE) generation for medicines.

Data holders are invited to register their RWD sources in the Catalogue of RWD sources, an initiative by the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA). This catalogue, along with the Catalogue of RWD studies, forms a comprehensive repository that describes RWD sources and studies, facilitating the generation of RWE for the use, safety, and effectiveness of medicines.

The Catalogue of RWD sources aims to be a central repository containing metadata information from data sources across Europe and beyond, with a focus on use for medicines regulatory purposes. It serves as a primary resource for identifying suitable data sources for non-interventional studies.

By registering data sources, the initiative aims to:

• Promote collaboration and data source utilization: Improve the identification of relevant data sources for non-interventional studies to foster partnerships and effective data usage.
• Increase accessibility to data sources: Enhance the visibility of data sources for regulators, researchers, and pharmaceutical companies to facilitate informed decision-making.
• Enhance regulatory insights: Enable regulators to interpret study results more accurately by leveraging specific data sources within regulatory frameworks.
• Integrate data sources with RWD studies: Connect registered data sources with studies in the Catalogue of RWD studies to enhance transparency in observational research.
• Initiate participation in DARWIN EU: Support the initial step towards becoming a data partner for DARWIN EU to promote collaborative data initiatives.

As of June 2024, the RWD Catalogues feature 216 registered data sources and 2840 studies worldwide, with each data source or study able to include data from multiple countries. In Europe, leading contributors include Germany (58 data sources), Italy (57), UK and Spain (each with 53). In terms of study registrations, the UK leads with 987 studies, followed by Germany (854) and Spain (741). Outside of Europe, notable contributors include the US (14 data sources), Israel (12) and Australia (11). In terms of studies, significant contributions come from the US (692), Canada (201) and Japan (128).

The EMA has also provided an update on its Big Data workplan to support innovation and public health within the EU. This joint effort by the HMA and EMA is crucial in prioritizing and preparing actions to make the best use of big data.