Saturday, April 20, 2024

New HMA-EMA Catalogs Featuring Real-World Data Sources and Studies Introduced

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The launch of new catalogs by the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) represents a significant stride towards enhancing the utility and transparency of real-world data (RWD) in the field of medicines regulation, research, and pharmaceutical development. This initiative aims to facilitate the identification of optimal data sources and support the comprehensive assessment of study protocols and results by medicines regulators, researchers, and pharmaceutical companies.

By promoting transparency, encouraging adherence to best practices, and fostering trust in real-world data-based research, these catalogs are poised to revolutionize the landscape of pharmacoepidemiology and pharmacovigilance within Europe.

Leveraging 15 Years of ENCePP Experience in Pharmacoepidemiology and Pharmacovigilance

  1. The Catalogue for RWD Sources: This catalog enhances and supersedes the ENCePP Resources Database, previously an EMA-coordinated index listing available research organizations, networks, and data sources in the realms of pharmacoepidemiology and pharmacovigilance across Europe. It serves as a comprehensive resource for identifying relevant data sources to address specific research inquiries.
  2. The Catalogue for RWD Studies: Expanding upon and replacing the European Union electronic register of post-authorization studies (EU PAS Register®), this catalog offers an extensive repository of real-world data studies, facilitating a deeper understanding and broader access to ongoing and completed research in the field.

Accompanying these catalogs, the ENCePP website has undergone a significant renewal. While the transition has seen the migration of some data sources and all centers and networks to the new catalogs, essential resources such as the ENCePP Guide on Methodological Standards in Pharmacoepidemiology and the ENCePP Code of Conduct will continue to be accessible through the revamped website.

The catalogs introduce several enhancements over their predecessors, adhering to the ‘FAIR’ data principles (Findable, Accessible, Interoperable, and Reusable). They employ a standardized set of metadata, as outlined by the HMA-EMA Big Data Steering Group, to meticulously describe and link data sources with studies, promising a more integrated and user-friendly experience.

With features like advanced metadata search capabilities, and improved viewing, exporting, and data submission functionalities, these catalogs represent a leap forward in making real-world data more discoverable and usable.

Real-World Data

Enhanced Real-World Data Catalogues Embrace ‘FAIR’ Data Principles for Improved Integration and User Experience

The publication of these real-world data catalogs is a crucial component of the European medicines regulatory network’s shift towards a more data-driven regulatory approach. This effort aligns with the priorities identified in the HMA-EMA joint Big Data Task Force final report (phase two) and is encapsulated in the European medicines agencies network strategy for 2025. By enhancing the discoverability and usability of data, these developments are expected to expedite the delivery of superior medicines to European patients, ensuring their safety and efficacy.

The call to utilize these catalogs extends to all European data holders, marketing authorization holders, networks, researchers, and institutions involved in or interested in medicines regulation or obligated by policies on non-interventional post-authorization safety studies (PASS).

This initiative not only underscores the commitment to improving healthcare outcomes through better-informed regulatory and research practices but also paves the way for a future where data-driven insights foster the development and safe use of medicines across Europe.

 

Resource: Europen medicines agency, February 15, 2024

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