The EU Biotech Act and FAST-EU: Accelerating Clinical Research in Europe

On 16 December 2025, the European Commission proposed the EU Biotech Act, a package of measures designed to improve public health while strengthening the resilience and competitiveness of the European life sciences sector. The proposals include significant amendments to Regulation (EU) No 536/2014 (EU CTR), with the aim to making the EU faster and more competitive for clinical trials conduct. Several of the proposals aim to reduce clinical trial review timelines and make the review process more efficient and some of these have been explored through the FAST-EU pilot project during 2026.
This session will examine how the FAST-EU pilot has tested some key elements of these proposed changes and considers how the lessons learned may shape the future clinical trials regulatory landscape. Participants will gain insights into emerging regulatory developments, potential impact on sponsors and investigators, and the practical implications for clinical trial planning, approval and conduct within the EU.