The European Medicines Agency has published the first global guidance on metadata to empower systematic integration of real-world evidence in medicines regulation, and is entitled Good Practice Guide for the use of the Metadata Catalogue of Real-World Data Sources.
The guide provides recommendations on how to use the catalogue of real-world metadata that is currently being built and in late 2023 will replace the existing catalogue of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). The guide will help to identify suitable real-world data sources for studies and describes the metadata elements that will be used.
Real-world data are observational data stored in repositories such as electronic health records and disease registries. Metadata characterize real-world data and are essential to improve data discoverability, create a clearer understanding of their meaning and achieve greater reliability and quality when using them to improve the evidence available for benefit-risk decisions. Overall, they help to get better medicines to patients.
The EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations.
You can read the full guide here.
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- The material in these reviews is from various public open-access sources, meant for educational and informational purposes only
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