Europe has been striving for several years to strengthen its attractiveness as a destination for clinical research. Despite a harmonized regulatory framework established through Regulation (EU) No. 536/2014 and the implementation of the Clinical Trials Information System (CTIS), clinical trial start-up timelines are still frequently cited as a barrier to innovation.
To address this challenge, European authorities launched FAST-EU (Facilitating and Accelerating Strategic Clinical Trials in the European Union), a pilot initiative designed to accelerate the assessment and authorization of selected strategic clinical trials conducted across multiple Member States.
Only a few months after its launch, the first results of FAST-EU are already attracting attention from sponsors, CROs, biotech companies, and pharmaceutical organizations. This initiative could pave the way for a new approach to conducting multinational clinical trials across Europe.
What Is FAST-EU?
FAST-EU is an initiative coordinated by the Clinical Trials Coordination Group (CTCG) under the umbrella of the Heads of Medicines Agencies (HMA) network.
Its objective is straightforward: to enable faster and more coordinated assessments of strategic clinical trials involving several European countries.
The initiative builds on the foundations established by Regulation (EU) No. 536/2014 on clinical trials on medicinal products for human use, which became fully applicable in January 2025. The regulation has already simplified clinical trial submissions through the CTIS portal, a single-entry platform designed to centralize authorization requests across the European Union.
However, FAST-EU goes a step further by testing enhanced cooperation between national competent authorities in order to further reduce assessment timelines.
Why Was FAST-EU Created?
Clinical research has become a key factor in international competitiveness.
While the United States remains the leading destination for industry-sponsored clinical trials, several Asian countries continue to attract increasing investment thanks to streamlined procedures and strong patient recruitment capabilities.
Europe nevertheless offers significant advantages:
- Highly recognized healthcare institutions;
- Experienced investigators;
- High scientific standards;
- Strong participant protection requirements.
Despite these strengths, sponsors frequently highlight the administrative complexity associated with multinational clinical trials.
FAST-EU was therefore designed to demonstrate that it is possible to maintain high standards of quality, safety, and ethics while significantly accelerating regulatory procedures.
The initiative also aligns with broader European efforts to strengthen biomedical innovation and facilitate earlier patient access to innovative therapies.
How Does FAST-EU Work?
The FAST-EU pilot focuses primarily on clinical trials considered strategically important for public health or therapeutic innovation.
Selected applications benefit from enhanced collaboration among participating Member States to facilitate:
- Scientific assessment;
- Regulatory coordination;
- Communication between authorities;
- Rapid resolution of questions arising during the review process.
The initiative aims to achieve coordinated authorization within as little as 70 calendar days, while fully complying with European clinical trial regulations.
This approach relies on closer cooperation between national authorities without altering their respective responsibilities for regulatory assessment.
Are the First FAST-EU Results Encouraging?
The first results released by European authorities demonstrate immediate interest in the FAST-EU program.
During the first three months of operation, the FAST-EU Coordination Office received 68 Expressions of Interest from European and international sponsors. These applications involved multinational clinical trials with dossiers already completed or at an advanced stage of preparation for submission through CTIS.
Among these applications, 15 clinical trials were selected for participation in the pilot. The selected projects involve 26 European Union and European Economic Area countries, with an average of more than seven participating countries per procedure and up to 14 countries involved in a single trial.
The first operational outcomes are equally encouraging. The first three completed procedures achieved the target of coordinated authorization within 70 calendar days, demonstrating that accelerated assessment can be achieved without compromising European regulatory and ethical standards.
Source: https://www.hma.eu/about-hma/recently-published.html
The 15 selected trials cover a broad range of therapeutic areas. Oncology and hematology account for nearly half of the selected projects (7 trials), followed by neurology and neurodegenerative diseases (2 trials), cardiovascular and pulmonary vascular diseases (2 trials), and immunology and inflammatory diseases (2 trials).
This distribution highlights the importance that FAST-EU places on therapeutic areas where unmet medical needs remain significant and where accelerated clinical development can have a meaningful impact for patients.
What Impact Could FAST-EU Have on Sponsors and CROs?
For both industry and academic sponsors, every month gained during clinical development can provide a substantial advantage.
Faster trial implementation can help:
- Accelerate patient recruitment;
- Optimize research investments;
- Reduce development delays;
- Improve access to innovative therapies.
CROs may also benefit from greater predictability in regulatory timelines, a critical factor when managing international studies.
For smaller biotech companies operating with limited resources, reducing administrative timelines can significantly improve the viability of development programs.
FAST-EU and Regulation (EU) No. 536/2014: Complementary Approaches
Rather than replacing the European Clinical Trials Regulation, FAST-EU complements and strengthens it.
Regulation (EU) No. 536/2014 introduced several major improvements:
- A single application process through CTIS;
- Coordinated assessment among Member States;
- Increased transparency of clinical trials;
- Harmonized review timelines.
FAST-EU seeks to maximize the benefits of this framework by improving its practical implementation.
In many ways, the initiative serves as a large-scale testing ground for identifying opportunities to further optimize multinational clinical trial assessments.
What Role Could France Play in FAST-EU?
France continues to play a major role in European clinical research.
The country benefits from recognized expertise in several therapeutic areas, particularly oncology and rare diseases. Industry data also indicate that France remains one of Europe’s leading contributors to clinical research activity.
The success of FAST-EU could further strengthen the attractiveness of French investigational sites by facilitating participation in large international clinical trials.
For healthcare institutions, academic sponsors, and pharmaceutical companies, this represents an important opportunity to reinforce France’s position within the European innovation ecosystem.
FAST-EU: An Initiative Worth Following Closely
Launched in October 2025 as a pilot initiative, FAST-EU has already demonstrated promising early results.
The program addresses a widely shared objective: reducing administrative timelines without compromising scientific quality or participant protection.
If these initial outcomes continue to be confirmed, FAST-EU could become one of the most significant developments in European clinical research since the implementation of Regulation (EU) No. 536/2014.
For clinical research professionals, CROs, pharmaceutical companies, and investigators, FAST-EU already provides valuable insight into the future direction of clinical research in Europe: faster, more coordinated, and more competitive on a global scale.
