FAST-EU - Facilitating and Accelerating Strategic Clinical Trials in the EU/EEA

Ireland is taking part in the FAST-EU initiative. FAST-EU is a joint HMA, CTCG, and MedEthics EU pilot project to accelerate the coordinated assessment and authorisation of clinical trials that run in multiple EU/EEA countries.

Key Features

  • The full process – from submission in CTIS to final decision – has a maximum timeline of 10 weeks (70 days), including sponsor response times.
  • Validation and assessment happen in parallel, with Ethics Committee opinions fully integrated into the process.
  • The pilot operates fully within CTIS and the EU Clinical Trial Regulation.

Start Date: 30th January 2026

Clinical trial sponsors who want to take part can submit an Expression of Interest Form to: FAST-EU@hma.eu

The Expression of Interest Form and further guidance for sponsors is available in the FAST‑EU Sponsor Guide.