Expedited Assessment of Clinical Trials in the EU: FAST‑EU Pilot Project Begins on 30 January 2026

The sponsor´s guideline is now available.

FAST‑EU (Facilitating and Accelerating Strategic Trials) is part of the broader EU focus on strengthening clinical research in Europe by accelerating and streamlining procedures for multi‑national clinical trials.

FAST‑EU also serves as a pilot for the future implementation of the EU Biotech Act.

The sponsor´s guideline is now published on the CTCG website, under the FAST‑EU section. Heads of Medicines Agencies: Clinical Trials Coordination Group (CTCG).

FAST‑EU will launch on 30 January 2026. Sponsors who wish to participate and have a clinical trial ready for FAST‑EU submission via CTIS must submit the Expression of Interest Form, which can be found as an Annex to the new FAST‑EU Sponsor’s Guide.

See more background here: FAST‑EU LinkedIn LMST.

Denmark’s initiative offering expedited assessment for mono‑national phase I and integrated phase I/II trials will continue to run in parallel. See more information on our website.