Expedited Assessment in Denmark and EU

First, Denmark introduced expedited assessment of phase I and integrated phase I/II trials. Primarily for mono‑national trials, but also with the possibility of multi‑national trials.

Now, the opportunity for expedited assessment is being expanded through the joint EU initiative FAST‑EU (Facilitating and Accelerating Strategic Trials) for multi‑national trials.

FAST‑EU is part of the broader EU focus on strengthening clinical research in the EU 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 guideline can be found on the CTCG website under the FAST‑EU section. Heads of Medicines Agencies: Clinical Trials Coordination Group (CTCG).

Sponsors wishing to participate, and who 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 for expedited assessment of phase I and integrated phase I/II trials, launched on 14 August 2025, will continue to run in parallel. (See regulatory guidance here).