Real-Word Data Catalogues launched by EMA and HMA
Two public electronic catalogues will be accessible for real-word data sources and real-word data studies
On Feb. 15, 2024, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) revealed the launch of two public electronic catalogues for real-word data (RWD). The RWD catalogues are designed to assist regulators, researchers, and pharmaceutical companies in finding appropriate data sources for research and evaluation of study protocols and outcomes.
Developed to enhance transparency, promote best practices, and foster trust in RWD, the catalogues expand on previous databases created by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). The RWD sources catalogue is a replacement for the ENCePP Resources Database. The RWD studies catalogue supersedes the European Union electronic register of post-authorization studies. The ENCePP website has been updated. Information from various sources has been transferred to the updated catalogues, while certain content will still be available on the revised ENCePP website.
The new catalogues incorporate enhancements over the previous databases. A standardized set of metadata has been utilized to describe and link data sources to studies, following a list of metadata released by the HMA-EMA Big Data Steering group in May 2022. Implemented functionalities include an expanded range of metadata, improved viewing options, and enhanced capabilities for exporting and submitting data.
The release of the RWD catalogues helps the European medicines regulatory network move towards more data-driven regulation. Enhancing data visibility is a key focus outlined in the HMA-EMA joint Big Data Task Force final report (phase two), as seen in the European medicines agencies network strategy to 2025 and carried out through the joint HMA-EMA Big Data Steering Group work plan. In the end, these advancements will assist European patients in accessing improved medications more quickly and encourage the safe and effective use of the medications available on the market.
Source: EMA
