This post aims to provide basic information on the FAST-EU initiative. The information is by no means exhaustive.
What is the FAST-Initiative?
FAST-EU (Facilitating and Accelerating Strategic Clinical Trials) is a pilot initiative by
the Heads of Medicines Agencies (HMA), the Clinical Trials Coordination Group (CTCG) and MedEthics EU implemented within the framework of the Clinical Trials Regulation (CTR).
Operating within the EU Clinical Trials Regulation and CTIS, FAST-EU offers sponsors a predictable and efficient pathway for initial clinical trial applications.
FAST-EU is part of the comprehensive European strategy to strengthen competitiveness in biomedical research.
- The procedure provides for clear and ambitious timelines and coordination mechanisms to offer sponsors of clinical trials clearer and shorter assessment and approval periods.
- In contrast to other regions, the opinions of the ethics committees of all participating member states are already integrated into this ambitious process.
- The aim is to provide the highest ethical and scientific standards for the clinical profiling of innovative product candidates in Europe.
- In doing so, the EU is sending out a clear signal in favour of pharmaceutical innovation and increased cooperation between the member states.
Which member states are participating in FAST-EU?
All of the EU Member States except Malta, Luxembourg and Greece. are participating in FAST-EU
What is the objective of FAST and how is it achieved?
The objective of FAST-EU is to accelerate the coordinated assessment and authorisation
of multinational clinical trial applications by applying ambitious internal coordination
timelines and reinforced cooperation between Member States, while fully maintaining
scientific, safety and ethical standards
The core feature of FAST-EU is a maximum overall timeline of 10 weeks (70 calendar days) from CTIS submission to final conclusion, including sponsor response times.
- This is achieved through parallel validation and assessment workflows and a strengthened role of the RMS, while maintaining scientific, safety and ethical standards.
- Ethics Committee opinions are fully integrated across all participating Member States.
What does FAST-EU offer beyond accelerating individual clinical trials applications?
Beyond accelerating individual clinical trials applications, FAST-EU also functions as a structured learning and evidence-generation exercise.
What is the scope of FAST-EU?
FAST-EU applies to:
- initial applications for multinational clinical trials involving more than one
Member State, and - all categories of investigational medicinal products (IMPs),
FAST-EU does not apply to:
- mono-national clinical trials
- partial submissions under Article 11 of the CTR
- resubmissions of previously lapsed, withdrawn, invalid or rejected trials
- substantial modifications and subsequent additions of Member States
- combination trials under the COMBINE project
About the FAST-EU pilot commencing 30 January 2026
The pilot is designed to provide practical insights into the feasibility and challenges of the accelerated assessment model, thereby supporting the future implementation of the EU Biotech Act.
Is it a voluntary pilot and can participation be guaranteed?
Yes, FAST-EU is a voluntary pilot with a planned duration of a year and a limited number of applications per month, so participation cannot be guaranteed.
What are the pre-requisites to enter a trial into FAST-EU?
- multinational clinical trial with several participating Member State Countries (MSCs) in the EU/EEA
- readiness of the dossier for submission (i.e. the dossier is finalised and ready for
submission in CTIS)
What should a sponsor do in order to enter a trial into FAST-EU?
- To enter a trial that is ready for submission in CTIS into FAST-EU starting from 30 January 2026, sponsors should express their interest by sending the Expression of Interest Form which can be found as Annex to the FAST-EU Sponsor Guide. via e-mail to FAST-EU@hma.eu.
- A response can be expected within 5 business days.
Who is the selection of applications into FAST EU done by?
Selection of applications into the FAST-EU pilot is performed by the FAST-EU Selection
Committee, which is composed of members of CTCG and MedEthics EU, acting in
conjunction with the proposed RMS.
Is there detailed procedural information available on FAST-EU?
Yes, detailed procedural information is provided in the FAST-EU Sponsor Guide.
Source: HMA