The European Union unveiled FAST‑EU, a voluntary pilot intended to accelerate the start‑up timeline for multinational clinical trials with a maximum 70‑day (10‑week) timeline from sponsor submission to first patient dosing for eligible studies. The Medicines and Healthcare products Regulatory Agency (MHRA) and EU partners plan fast‑track routes for lower‑risk studies and a 14‑day assessment for certain phase I trials. FAST‑EU is designed to shorten administrative barriers and harmonize cross‑border processes to boost trial competitiveness in Europe. Sponsors should monitor eligibility criteria and operational changes that could affect trial planning and site selection.