Heard of this already? FAST-EU is a voluntary pilot program designed to achieve a ~70-calendar-day timeline from CTIS submission to final decision!🚀
The FAST-EU (Facilitating and Accelerating Strategic Clinical Trials in the EU) pilot that started end of January 2026 aims to significantly shorten approval timelines for multinational clinical trials under the EU Clinical Trials Regulation (CTR). It was launched by the Heads of Medicines Agencies (HMA) — and of course Germany is actively participating in the pilot through the PEI and the BfArM 👍
❗❗In order to manage the growing number of applications, application deadlines have been set: For the next round: March 23-24, 2026 (for applications to be submitted to CTIS in April) Sponsors are requested to indicate in their application whether the CTIS submission will be possible in the first or second half of the respective month.❗❗
⬇️ How to apply as a Sponsor
Sponsors must submit an “Expression of Interest” (Letter of Intent) before filing in CTIS:
📩 Submission via email to FAST-EU@hma.eu:
To register CTIS-enabled clinical trials in FAST-EU, please email the expression of interest form attached to the FAST-EU Sponsor Guide
⏱ Feedback expected within ~5 working days
📌 Dossier should be CTIS-ready immediately after slot confirmation!
Link to HMA official FAST-EU Sponsor Guide
⚙️ What Sponsors should be prepared for
FAST-EU is faster — but also demands:
✔ Rapid responses by sponsors to consolidated Requests for Information
✔ High-quality, submission-ready dossiers at the time of EOI
✔ Tight timelines with limited flexibility for iterative clarifications
✔ Strong internal regulatory and operational coordination
➡️If you are planning a multinational CTA in 2026, FAST-EU may be worth considering. Talk to us to get your trial going FAST 😉