The latest EMA report on DARWIN EU published in June reflects an important milestone for regulatory use of real-world evidence (RWE).
The continued growth of DARWIN EU shows the growing confidence in the role of high-quality RWE in regulatory settings. The question is no longer whether RWE can support regulatory decision-making, but how to generate regulatory-grade evidence that is transparent, robust, and fit for purpose.
This is where mature healthcare data ecosystems, especially those in the Nordic countries, continue to play an important role.
In the past decades, Nordic real-world data (RWD) have served as a benchmark for population-based observational research owing to their long-standing strengths in nationwide coverage, longitudinal follow-up, and reliable data linkage across data sources. This is reflected in the fact that out of approximately 1400 regulatory studies registered in the EMA Catalogue of RWD Studies as of April 2026, roughly 900 were conducted in the Nordics.
As expectations for regulatory-grade RWE continue to rise, we are excited to help you design and deliver robust studies that leverage the unique strengths of Nordic healthcare data.
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