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

As countries around the world race to update regulations and policies for launching clinical trials, alarm bells are ringing in Europe too about the need to compete for R&D. But Europe faces a uniquely daunting challenge because of the fragmented nature of its regulatory system — a disadvantage not shared by countries with a single point of contact and decision-making authority, and one that is unlikely to change anytime soon.

Europe is not late in recognizing the need. The past five years have brought several changes to the EU’s clinical trial framework, along with new proposals and pilots aimed at further refining and accelerating the process...