Fast-track clinical trials is emerging as a major strategic lever to strengthen the attractiveness of France and Europe in the field of drug clinical research.
In a context of intense international competition, the speed of authorisation and initiation of clinical trials directly conditions early patient access to innovative treatments and the ability of countries to attract high–scientific-value projects.
From the first quarter of 2026, France will implement a fast-track clinical trials procedure dedicated to medicinal products, under the leadership of the French National Agency for the Safety of Medicines and Health Products (ANSM).
This national initiative forms part of a broader momentum, complemented by an accelerated approach at European level for multinational clinical trials.
Source – ANSM: fast-track mechanism
Fast-track clinical trials ANSM 2026: objectives and scope
The fast-track clinical trials program announced by the ANSM targets both academic and industrial sponsors and focuses on trials meeting clearly defined eligibility criteria, primarily in the early phases of drug development.
The following trials are eligible:
- Phase I or integrated Phase I/II clinical trials,
- Trials involving:
- serious, rare or disabling diseases for which no appropriate treatment is available,
- first-in-class medicinal products, based on an entirely new mechanism of action,
- or trials promoting the inclusion of adolescents in adult clinical trials,
- Certain categories of mononational clinical trials.
The objective of the fast-track clinical trials program is explicit: significantly reduce authorisation timelines, without compromising safety requirements, ethical standards or scientific quality.
Authorisation timelines for drug trials cut in half
The ANSM has clearly stated its intention to substantially reduce regulatory timelines:
- 14 days under the fast-track procedure (compared with 31 days currently) for an authorisation without questions,
- A maximum of 49 days in the event of questions (compared with 106 days),
- For advanced therapy medicinal products (ATMPs), removal of the additional 50-day delay.
These changes represent a major operational shift for sponsors, enabling much faster initiation of clinical trials while maintaining regulatory oversight.
A coordinated European acceleration for multinational clinical trials
Alongside the French fast-track, a coordinated initiative at European level further strengthens this acceleration dynamic.
In 2025, the National Competent Authorities (NCAs) launched an accelerated approach for the authorisation of multinational clinical trials, within the framework of Regulation (EU) No 536/2014 and the Clinical Trials Information System (CTIS).
👉 Source – ANSM: accelerated EU/EEA approach
https://ansm.sante.fr/actualites/les-autorites-competentes-nationales-acn-lancent-une-approche-acceleree-pour-lautorisation-des-essais-cliniques-multinationaux-dans-lue-eee
This European fast-track approach aims to:
- improve coordination between Member States,
- streamline joint scientific assessments,
- reduce overall authorisation timelines for multinational clinical trials,
while maintaining high standards of safety and ethics.
Priority given to high medical-need projects
Both national and European fast-track clinical trials initiatives clearly prioritise high medical-need projects, including:
- trials in serious or rare diseases,
- breakthrough therapeutic projects,
- early-phase trials requiring rapid deployment across multiple countries.
This convergence reflects a clear strategic objective: strengthen European competitiveness in drug clinical research and improve patient access to innovative therapies.
Fast-track clinical trials require highly mature dossiers
While fast-track procedures accelerate timelines, they rely on one essential condition: the quality and maturity of submitted dossiers.
Sponsors must demonstrate:
- a robust and coherent clinical development strategy,
- a clear justification of unmet medical need,
- anticipated risk management,
- overall consistency of the clinical development plan.
In this context, fast-track clinical trials do not reduce scientific complexity.
On the contrary, they require enhanced anticipation and regulatory preparedness.
A targeted innovation logic, also relevant for medical devices
Although the fast-track framework currently applies exclusively to medicinal products, the eligibility criteria echo challenges faced by innovative medical device developers, particularly for:
- first-in-class medical devices,
- digital or implantable technologies,
- devices intended for small patient populations or addressing high unmet medical needs.
In such contexts, rapid access to high-quality clinical data is a critical lever to secure CE marking, market access and post-market surveillance strategies.
👉 Source – HAS: Medical device development pathway
https://www.has-sante.fr/jcms/p_3115486/fr/parcours-du-dispositif-medical
Conclusion – a strong signal for the clinical research ecosystem
The introduction of fast-track clinical trials, combined with the European accelerated approach, represents a structuring turning point in the authorisation of drug clinical trials.
While the scope currently concerns medicinal products only, these initiatives highlight organisational and methodological levers that may inspire stakeholders involved in medical device clinical development.
In an increasingly demanding regulatory environment, anticipation, dossier structuring and clinical data quality remain the key factors to accelerate development without compromising patient safety.
For academic and industrial sponsors, the message is clear:
success in a fast-track clinical trials context relies on solid, anticipated and coherent regulatory and clinical preparation.
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