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

Ireland is taking part in the FAST-EU initiative. FAST-EU (Facilitating and Accelerating Strategic Clinical Trials) 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.

How to participate

The pilot began on 30 January 2026 and is expected to run for one year.

Guidance for clinical trials sponsors can be found in the FAST-EU Sponsor Guide and on the CTCG website.

Sponsors who want to take part can submit an Expression of Interest Form (available in the FAST-EU Sponsor Guide) to: FAST-EU@hma.eu