New SOP to enhance transparency and quality of Real-World Data

ERDERA JTC2026

A new Standard Operating Procedure (SOP) titled “Validation, Publication, and Maintenance of Real-World Data Sources and Studies in the HMA-EMA RWD Catalogues” (SOP/TDA/3543) has been published by the European Medicines Agency (EMA). This SOP outlines the systematic approach adopted by the EMA for ensuring the accuracy, completeness, and transparency of data included in the HMA-EMA real-world data catalogues.

The SOP provides clear guidance for both EMA staff and catalogue users on the processes of data validation, publication, and ongoing maintenance. It ensures that submitted data sources and studies are not only relevant and non-duplicative, but also supported by comprehensive and standardised metadata.

Notably, this new procedure will help strengthen the robustness of the real-world evidence ecosystem, ultimately enhancing its credibility and accountability in regulatory decision-making. Learn more from the document.

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