Clinical Trial Initiatives

Below sponsors can find information about European clinical trial initiatives that Ireland is participating in.

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

COMBINE Pilot

Ireland is participating in the COMBINE pilot programme. The goal of the COMBINE pilot is to test the feasibility of a coordinated assessment of clinical trials conducted in parallel with performance studies of in-vitro diagnostics or clinical investigations of a medical device. Following on from the success of Phase I, the next phase expands the scope of accepted applications and extends the expression of interest period.

Key features

  • A single application for the coordinated assessment of combined studies – a clinical trial of a medicinal product combined with either a performance study of an in vitro diagnostic or a clinical investigation of a medical device.
  • The clinical trial and performance study/clinical investigation can have the same or separate sponsors.
  • The pilot operates through CTIS and in accordance with the CTR, MDR, and IVDR.

How to participate

Sponsors can now express their interest in participating in Phase 2 of the pilot. The pilot began in September 2026 and is expected to run for one year.

Sponsors who want to take part can submit an expression of interest and protocol synopsis to: EUcombinepilot@ccmo.nl

Further information and guidance for clinical trial sponsors can be found on the European Commission COMBINE webpage.