Publication|
17 April 2026

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The EU regulatory framework for healthcare is entering a period of profound change. A series of major initiatives – from the Pharma Package and Critical Medicines Act to MDR simplification and the proposed Biotech Act – are progressing in parallel and are already influencing market access, supply chain configuration and investment decisions across the sector. 

With the final text of the Pharma Package published on 6 March, the direction of travel is now much clearer for companies and investors with exposure to the EU. 

Our EU Healthcare Regulatory Update 2026 outlines the key elements we see as most relevant for pharma, medtech and biotech businesses and their investors, and sets out some of the strategic inflection points for portfolio, launch and deal planning.