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The European Biotech Act 2026: What the New EU Biotechnology Framework Means for Pharma, Biotech and Regulatory Affairs Careers
The **European Biotech Act** is a European Commission legislative proposal, published as **COM(2025) 1022 final on 16 December 2025**, designed to close the EU's competitiveness gap in health biotechnology against the US and China. It affects pharmaceutical companies, biotech start-ups, investors and regulatory affairs professionals working with **ATMPs**, mRNA therapeutics, biologics and biosimilars. The Act introduces faster clinical trial timelines, EU-anchored investment
4 hours ago12 min read



