EDPB and EDPS support harmonisation of clinical trials under European Biotech Act, but call for specific safeguards for sensitive health data (edpb.europa.eu)

• Need for clear controller role definition in clinical trials
• Restriction of mandatory 25-year retention to master files only
• Integration of GDPR-compliant safeguards within regulatory sandboxes

"European data protection regulators have issued a joint opinion on the proposed EU Biotech Act, backing efforts to harmonize clinical trial regulations while insisting on robust data privacy safeguards. The EDPB and EDPS emphasize that industrial competitiveness must not erode fundamental rights. They call for clearer allocation of data controller roles, specific retention limitations, and mandatory alignment with the EU AI Act to maintain a coherent and trustworthy legal landscape for medical research."