The European Union launched FAST‑EU, a voluntary one‑year pilot designed to accelerate multinational clinical trial start‑up timelines. The program sets a maximum 70‑day (10‑week) timeline from application to first patient dosing for eligible trials and introduces expedited assessment routes for lower‑risk studies and phase I healthy‑volunteer trials. Regulators expect streamlined approval processes to cut administrative delays and encourage cross‑border clinical research. Sponsors running multinational programs should expect new timelines and be prepared to align dossiers and site readiness to the pilot’s accelerated cadence.