The EU reached an agreement on the Critical Medicines Act, aimed at reducing shortages by boosting manufacturing capacity and strengthening joint procurement for critical drugs, including orphan medicines. The framework is intended to address supply chain vulnerabilities exposed during COVID-19. Key elements include requirements for member states to prioritize supply chain security and diversification over lowest-price selection in public procurements. The act also includes “buy European” incentives for suppliers manufacturing within the EU and fast-track permitting supported by EU funding. For biotech and pharma, the pact increases regulatory and operational emphasis on local or diversified manufacturing strategies, potentially affecting how companies structure partnerships, supply agreements, and contingency plans for active ingredients and finished drugs.