The recent unveiling of novel catalogs for real-world data (RWD) heralds an important advancement within the European medicines regulatory landscape, aimed squarely at enhancing the ability of medicines regulators, researchers, and pharmaceutical entities to pinpoint the most relevant data sources for their specific research inquiries. This development is poised to significantly boost transparency, promote adherence to established best practices, and engender greater trust in research grounded in real-world data.
This initiative, building upon the solid groundwork established by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) over the preceding 15 years, seeks to modernize and broaden the scope of previously established databases. Specifically, the catalog dedicated to real-world data sources serves to update and supersede the ENCePP Resources Database, providing an exhaustive listing of research organizations, networks, and data sources throughout Europe that specialize in pharmacoepidemiology and pharmacovigilance.
Moreover, the catalog focusing on real-world data studies extends beyond the scope of the prior European Union electronic register of post-authorization studies (EU PAS Register®), marking a significant leap in data accessibility and utility. Accompanying these catalogs is a refreshed ENCePP website, which continues to host essential resources such as the ENCePP Guide on Methodological Standards in Pharmacoepidemiology and the ENCePP Code of Conduct while transitioning some data sources and all centers and networks to the revamped catalogs.
New Catalogs Embrace FAIR Principles for Enhanced European Medicines Regulatory Network
The newly introduced catalogs boast several key improvements over their predecessors. Adhering to the ‘FAIR’ data principles—Findable, Accessible, Interoperable, and Reusable—these catalogs employ a universally agreed-upon set of metadata to delineate and connect data sources with pertinent studies. This approach is grounded in the metadata list published by the HMA-EMA Big Data Steering group in May 2022, with a revision anticipated shortly.
Furthermore, these catalogs feature enhancements such as a broader range of searchable metadata, improved viewing and exporting capabilities, and streamlined data submission processes, all of which are designed to nudge the European medicines regulatory network towards a more data-centric regulatory model. This shift is in line with the objectives outlined in the HMA-EMA joint Big Data Task Force final report (phase two), as embodied in the European medicines agencies network strategy extending to 2025 and executed through the concerted efforts of the HMA-EMA Big Data Steering Group work plan.
Real-World Data Catalogs Set to Transform European Medicines Regulation
The introduction of these real-world data catalogs is anticipated to fast-track the delivery of superior medications to European patients, enhancing both the safety and efficacy of available medicines. By bolstering the discoverability of data, these innovations underpin a regulatory environment that is increasingly driven by data, offering significant advantages to all parties involved in the regulation of medicines. This includes data holders, marketing authorization holders, networks, researchers, and institutions, all of whom are encouraged to leverage these catalogs to facilitate the regulation of medicines or to comply with policies on non-interventional post-authorization safety studies (PASS).
These catalogs not only symbolize a critical step towards streamlining the European medicines regulatory process but also underscore a commitment to harnessing the power of data to improve patient outcomes and advance the field of medicine.
Resource: Ema, February 15, 2024
This article has been prepared with the assistance of AI and reviewed by an editor. For more details, please refer to our Terms and Conditions. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author.
