Collaboration between HMA and EMA introduces electronic catalogues of real-world data sources and studies

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have jointly introduced two publicly accessible electronic catalogues: one dedicated to real-world data (RWD) sources and the other focused on RWD studies.

The release of the new HMA–EMA catalogues marks an advancement in the accessibility and utilization of RWD within the pharmaceutical and regulatory spheres. The catalogues serve as centralized repositories of metadata collected from RWD pharmacoepidemiology and pharmacovigilance sources, and post-authorization studies. Their purpose is to provide valuable support for medicines regulators, researchers, and pharmaceutical companies by aiding in the identification of suitable data sources to address specific research questions and assisting in the assessment of study protocols and findings. As noted by the EMA, their aim is to ‘promote transparency, encourage the use of good practices, and build trust in research based on RWD.’

This initiative builds upon over 15 years of operation of previous databases established by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). Replacing the ENCePP Resources Database and the European Union electronic register of post-authorization studies (EU PAS Register^®), respectively, the catalogue of RWD sources and the catalogue of RWD studies offer an enhanced and streamlined approach to accessing relevant data. The renewal of the ENCePP website also complements these advancements, ensuring continued access to essential resources including the ENCePP Guide on Methodological Standards in Pharmacoepidemiology and the ENCePP Code of Conduct.

Stakeholders across Europe, including data holders, marketing authorization holders, networks, researchers, and institutions, are encouraged to leverage these catalogues to support medicines regulation and non-interventional post-authorization safety studies (PASS). The catalogues are fully searchable, with users able to export the data available in the registered entities. Key improvements introduced in the catalogues are rooted in the principles of ‘FAIR’ data—making data Findable, Accessible, Interoperable, and Reusable. By utilizing standardized metadata, enhancing search capabilities, and improving data submission functionalities, these catalogues offer a more efficient and user-friendly experience.

As the EMA note, the publication of these RWD catalogues signifies a significant step towards a more ‘data-driven’ regulatory framework in Europe. This aligns with the objectives outlined in the HMA–EMA joint Big Data Task Force final report and the European medicines agencies network strategy to 2025, which ultimately aim to expedite the delivery of safer and more effective medicines to European patients.

Stakeholders can learn more about the HMA–EMA catalogues of RWD sources and studies in an upcoming webinar scheduled for March 4, 2024 (10:00–12:00 CET).