FAST-EU: Accelerating Multinational Clinical Trial Assessments in the EU/EEA
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FAST-EU (Facilitating and Accelerating Strategic Trials) is a collaborative European initiative by HMA, CTCG, and MedEthics EU, offering sponsors the opportunity for faster processing of clinical trial applications. Operating under the existing EU Clinical Trials Regulation (Regulation (EU) No 536/2014) and CTIS, FAST-EU provides a streamlined pathway for multinational clinical trials. It also serves as a pilot for the future implementation of the EU Biotech Act.
Key Features
- Accelerated Timelines: FAST-EU guarantees a maximum of 10 weeks (70 calendar days) from CTIS submission to final decision, including sponsor response times. This is achieved through parallel validation and assessment workflows and a strengthened role of the Reporting Member State (RMS).
- Integrated Ethics Reviews: Ethics opinions are harmonised across all participating Member States.
- Pilot Goals: Beyond faster assessments, FAST-EU provides sponsors with practical insights into an accelerated workflow, contributing to the development of a model to make Europe more attractive for clinical research.
How to Participate
Sponsors interested in participating must submit the "Expression of Interest" form, which is included as an annex to the FAST-EU Sponsor Guide, available on the CTCG website. Sponsors with clinical trials ready for submission in CTIS can email their completed form to FAST-EU@hma.eu. Submission windows are outlined in the guide, and responses are provided within five business days.
Participating Member States
The following countries are part of FAST-EU: Austria, Belgium, Denmark, Finland, France, Germany, Italy, Norway, Spain, Sweden, and others. Sponsors are encouraged to select RMS that have not yet been chosen in previous rounds to ensure equitable workload distribution.
Why Join FAST-EU?
FAST-EU allows sponsors to test shorter processing times, gain insights into new workflows, and contribute to shaping Europe's clinical trial landscape. The pilot is voluntary, with a planned duration of one year and a limited number of applications accepted per month.
Learn More
For detailed guidelines, submission windows, and additional information, refer to the FAST-EU Sponsor Guide on the CTCG website.