The acceleration of clinical trials in Europe has become a strategic priority for health authorities, industrial sponsors and research institutions. In a context of increasing international competition, several initiatives aim to improve coordination and speed up the evaluation of clinical studies.
Among them, the FAST-EU project (Facilitating Accelerated Clinical Trials in the European Union) is attracting growing attention. According to a recent communication published by Heads of Medicines Agencies (HMA), the FAST-EU project received 23 applications during the latest submission period, illustrating the increasing interest of sponsors in this initiative.
Source: https://www.hma.eu
Acceleration of clinical trials in Europe: a strategic objective
The acceleration of clinical trials in Europe is now at the core of policies aimed at strengthening the continent’s attractiveness for biomedical research.
In recent years, several analyses have shown that Europe’s share of global clinical trials has gradually declined, particularly in comparison with the United States and certain regions of Asia. In this context, European authorities are seeking to simplify and harmonize authorization procedures.
One of the pillars of this transformation is Regulation (EU) No 536/2014 on clinical trials, which entered into application in 2022.
This regulation introduced several major developments:
- a single submission for clinical trial applications
- a coordinated assessment between Member States
- increased transparency of clinical data
These changes are specifically intended to facilitate the acceleration of clinical trials in Europe while maintaining high scientific and ethical standards.
FAST-EU: a pilot project to improve coordination
In this context, the FAST-EU project represents an initiative designed to test new coordinated evaluation approaches.
The project relies on close collaboration between:
- national competent authorities
- ethics committees
- clinical trial sponsors
The objective is to streamline the evaluation process for multinational clinical studies, which often face varying administrative timelines depending on the country.
The most recent FAST-EU submission window received 23 applications, confirming the growing interest of the clinical research ecosystem in this type of initiative.
Faced with this high number of requests, the participating Member States decided to accept four applications for this cycle, once again exceeding the initial expectations. This decision reflects the determination of European authorities to actively support initiatives contributing to the acceleration of clinical trials in Europe.
Designated reporting Member States
For the applications selected in this FAST-EU cycle, several Member States have been designated as reporting Member States responsible for conducting the scientific evaluation.
The countries involved are:
- Belgium
- Norway
- Spain
- Czech Republic
Under the European Clinical Trials Regulation, the reporting Member State plays a central role. It coordinates the scientific assessment of the dossier and prepares a report shared with the other national authorities participating in the procedure.
This organization helps avoid the duplication of national assessments and improves the efficiency of the authorization process, thereby contributing to the acceleration of clinical trials in Europe.
FAST-EU and CTIS: complementary mechanisms
The FAST-EU project builds on the European regulatory infrastructure already in place, particularly the Clinical Trials Information System (CTIS).
https://www.ema.europa.eu/en/clinical-trials-information-system-ctis
CTIS is now the single entry point for all clinical trial applications in the European Union. This platform allows:
- the submission of a single dossier for several Member States
- a coordinated evaluation between authorities
- the publication of information on clinical trials
By facilitating coordination between national authorities, CTIS already contributes to the acceleration of clinical trials in Europe. FAST-EU aims to go further by testing even faster and more coordinated evaluation approaches.
A new submission window in April 2026
The FAST-EU project continues to develop, with the next submission window scheduled from 22 to 23 April 2026.
Applicants are invited to inform authorities of their preferred submission weeks in CTIS, in order to optimize the organization of the evaluation process.
This forward planning should enable:
- better coordination between national authorities
- smoother management of applications
- shorter evaluation timelines
All these elements are intended to support the acceleration of clinical trials in Europe.
A key challenge for European attractiveness
The acceleration of clinical trials in Europe has become a major challenge for biomedical innovation. Authorization timelines, regulatory complexity and coordination between Member States directly influence the continent’s ability to attract international clinical research projects.
In this context, initiatives such as FAST-EU demonstrate the willingness of European authorities to improve procedural efficiency while maintaining high standards of participant protection and scientific quality.
If these approaches prove successful, they could significantly strengthen Europe’s competitiveness in global clinical research and sustainably support the acceleration of clinical trials in Europe.
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See other articles on the same subject: FAST-EU pilot for multinational clinical trials: accelerating clinical trial authorisation in the European Union
