Big ambitions, big fractures — Europe’s FIH conundrum: Back to School 2026

Stephen Hansen, Director of Biopharma Intelligence, examines Europe's struggle to compete globally for first-in-human (FIH) clinical trials because of its fragmented regulatory system. Unlike countries with a single point of contact and decision-making authority, the EU faces a disadvantage that is unlikely to change soon, despite five years of changes to its clinical trial framework plus new proposals and pilots. The piece surveys competing FIH efforts in the U.S., Australia, China and Asia ex-China, and notes fast lanes in Spain, Denmark and the U.K.