Keynote: The EU’s Biotech & Bio-Manufacturing Strategy

the European Commission published a communication launching the EU Biotech and Biomanufacturing Initiative to enhance competitiveness and industrial modernization. These efforts seek to foster innovation, facilitate investment, and position the EU as a leading hub for biotechnology and biomanufacturing.

The initiative proposes eight key actions, including most notably:

• Launching a study to support the simplification and streamlining of the EU regulatory framework for biotech (potentially leading to an EU Biotech Act)
• Establishing an EU Biotech Hub to support navigation of the regulatory framework and scale up
• Setting up several mechanisms to increase funding and investment in EU biotech and biomanufacturing
• Reviewing the EU Bioeconomy Strategy
• These actions have significant implications for stakeholders within the EU life sciences ecosystem—especially in the context of the ongoing Pharma Package negotiations and the upcoming EU elections and institutional changeovers.