Regulatory developments.
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Time-stamped news on health data policy, FDA and EMA regulatory updates, and real-world evidence developments — written for pharmaceutical and MedTech professionals who need to act on what changes.
EHDS Implementing Acts Consultation: Commission Releases Draft HDAB Specifications
The European Commission has released draft implementing act specifications for Health Data Access Bodies under the EHDS regulation, opening a formal consultation period. For pharmaceutical and MedTech organisations developing real-world evidence strategies, understanding these specifications now is not optional.
Read the full article →EMA Publishes Updated Reflection Paper on RWD Use in Non-Interventional Studies
The European Medicines Agency has published a revised reflection paper on the use of real-world data in non-interventional studies for regulatory purposes. The update places greater emphasis on study pre-specification, data provenance, and methodological transparency — areas of intensifying regulatory scrutiny. RWE, HEOR, and regulatory affairs teams should review existing non-interventional study protocols against current EMA expectations.
FDZ Gesundheit announces extended data model covering ambulatory specialist care
Germany's Forschungsdatenzentrum Gesundheit (FDZ) has announced an extension to its data model that now incorporates ambulatory specialist care, meaning …
FDA Issues Draft Guidance on AI/ML in Drug Development Using Real-World Data
The FDA has published draft guidance addressing the use of artificial intelligence and machine learning tools in drug development contexts that rely on real-world data. Regulatory affairs and RWE teams should review the draft now and begin assessing where their current AI workflows may require additional documentation ahead of formal implementation.
EHDS Implementing Acts Consultation: Commission Releases Draft HDAB Specifications
The European Commission has released draft implementing act specifications for Health Data Access Bodies under the EHDS regulation, opening a formal consultation period. For pharmaceutical and MedTech organisations developing real-world evidence strategies, understanding these specifications now is not optional.
FDA Removes Patient-Level Data Barrier for RWE Submissions: What Pharma and MedTech Teams Need to Know Now
The FDA's December 2025 announcement eliminating patient-level data requirements for real-world evidence submissions is one of the most significant regulatory developments in the RWE space in years.
FDZ Gesundheit: Ambitious Targets, Slow Delivery — What the Performance Gap Means for Pharma Evidence Timelines
Over 100 applications submitted since October 2025, a fraction completed, individual applicants waiting six months for results. What the FDZ performance gap means for pharma teams planning German health data access.
More news articles will appear here as regulatory and health data developments warrant coverage.
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