The FAST-EU pilot for multinational clinical trials marks a significant milestone in the transformation of the European clinical research regulatory framework.
Since the end of January 2026, the European Union has launched an innovative pilot programme called FAST-EU (Facilitating and Accelerating Strategic Trials), designed to accelerate the authorisation and initiation of multinational clinical trials.
This initiative is part of a broader regulatory reform driven by the European Commission, aimed at strengthening Europe’s competitiveness in global clinical research and reversing the gradual decline in the EU’s share of sponsored clinical trials worldwide.
The main objective of the FAST-EU pilot for multinational clinical trials is to shorten evaluation timelines, improve predictability for sponsors, and enhance the EU’s attractiveness as a global clinical research hub, while maintaining high standards of patient safety, ethics and scientific quality.
As a reminder, France recently announced the implementation, from the first quarter of 2026, of a national fast-track authorisation procedure for certain clinical trials conducted on French territory.
Sources:
https://laegemiddelstyrelsen.dk/en/news/2026/expedited-assessment-of-clinical-trials-in-the-eu-fasteu-pilot-project-begins-on-30-january-2026
https://ansm.sante.fr/actualites/les-autorites-competentes-nationales-acn-lancent-une-approche-acceleree-pour-lautorisation-des-essais-cliniques-multinationaux-dans-lue-eee
FAST-EU pilot for multinational clinical trials: what is it exactly?
The FAST-EU pilot for multinational clinical trials is a voluntary coordination mechanism involving national competent authorities (NCAs) and ethics committees across the European Union and the European Economic Area (EEA).
Its purpose is to establish clear, ambitious and harmonised timelines for the assessment of multinational clinical trial applications submitted through the European CTIS portal (Clinical Trials Information System).
Within this framework, sponsors who choose to use FAST-EU commit to a fast, coordinated and transparent evaluation process, designed to significantly reduce uncertainty related to authorisation timelines up to the final decision.
This represents a substantial shift compared with the traditional model, where evaluations were often longer, less synchronised and more heterogeneous between Member States.
It is important to note that the FAST-EU pilot for multinational clinical trials applies exclusively to clinical trials of medicinal products for human use, conducted under Regulation (EU) No 536/2014.
It does not apply to clinical investigations of medical devices, which remain governed by Regulation (EU) 2017/745 (MDR).
Strategic objectives of the FAST-EU pilot
Accelerating authorisation timelines
One of the core ambitions of the FAST-EU pilot for multinational clinical trials is to reduce the overall duration of dossier assessment in a multinational context.
Through FAST-EU, sponsors can expect more predictable and shorter evaluation timelines, a critical factor for efficient planning of subsequent clinical development phases.
Strengthening Europe’s attractiveness for clinical R&D
Over recent years, the share of global sponsored clinical trials conducted in the EU has declined significantly, partly due to administrative timelines and regulatory complexity.
Improving the competitiveness of authorisation procedures is therefore a strategic lever to attract more clinical research investments and international sponsors back to Europe.
Harmonisation and cooperation between Member States
The FAST-EU pilot for multinational clinical trials relies on reinforced coordination mechanisms between NCAs and ethics committees to ensure a joint, coherent and faster assessment process.
This includes, for example:
- harmonised review calendars,
- structured exchanges between authorities,
- improved alignment of national positions during assessment.
This enhanced cooperation aims to limit divergence between Member States and reduce delays linked to fragmented evaluations.
Regulatory context: the Biotech Act and ecosystem transformation
The FAST-EU pilot for multinational clinical trials is embedded in a broader European regulatory reform context, notably through the proposed European Biotech Act, part of the EU Life Sciences Strategy.
This legislative package aims to:
- strengthen the European biotechnology sector and biopharmaceutical production,
- simplify regulatory pathways for innovative products,
- create more efficient processes for R&D, clinical trials and scale-up.
Although the FAST-EU pilot focuses exclusively on clinical trials of medicinal products, the momentum generated by the European Biotech Act goes beyond this scope.
The European Commission has clearly stated its ambition to enhance the overall competitiveness of the European life sciences ecosystem, including biotechnologies, advanced therapies and, indirectly, medical devices.
Sources:
https://www.schoenherr.eu/content/eu-pathways-to-health-innovation-the-biotech-act-i-and-medical-device-reform
https://ec.europa.eu/commission/presscorner/detail/en/ip_25_3077
Expected impacts for the pharmaceutical industry and patients
For sponsors and biotech companies
The FAST-EU pilot for multinational clinical trials offers several concrete benefits:
- improved predictability of authorisation timelines through a coordinated and transparent procedure;
- reduced regulatory uncertainty and associated planning costs;
- strengthened attractiveness of Europe for commercial clinical trials, potentially reversing the decline observed in recent years.
For patients
From a patient perspective, the expected benefits are equally significant:
- faster access to promising therapeutic innovations, particularly in rare or unmet medical needs;
- reinforced European cooperation between regulatory authorities, supporting scientific quality and patient safety.
Conclusion
The launch of the FAST-EU pilot for multinational clinical trials represents an important step in the transformation of the European clinical trial regulatory framework.
By offering shorter evaluation timelines, improved coordination between Member States and greater predictability, FAST-EU has the potential to significantly enhance the EU’s attractiveness for global clinical research.
This initiative is not isolated. It forms part of a broader reform effort driven by the European Biotech Act and the Life Sciences Strategy 2030, with the stated ambition of positioning Europe as a more competitive hub for health innovation.
In this evolving context, CROs and clinical research stakeholders must anticipate regulatory changes and adapt their operational strategies to secure timelines for the implementation of multinational clinical trials.
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Complementary articles: European Biotech Act: a new strategic framework to accelerate innovation in medicines and medical devices, FAST-EU: a new step toward the acceleration of clinical trials in Europe
