Following the January 2026 HMA confirmation, the European Union and France have launched coordinated fast-track pilots for clinical trials, significantly reducing authorisation timelines for high-quality, innovative research dossiers.

Overview

In January 2026, the Heads of Medicines Agencies ("HMA") confirmed the launch of a fast-track authorisation pathway for certain clinical trials, scheduled to take effect in the first quarter of 2026.

This initiative marks a significant shift in Europe's clinical research policy, with a clear objective: restoring Europe's competitiveness in early-stage and innovative clinical development, while enabling patients to gain earlier access to breakthrough therapies.

This initiative responds to a significant decline in Europe's share of global clinical research. Over the past decade, the proportion of clinical trials conducted in the European Economic Area has fallen from approximately 22% to 12%, while China's share has doubled to 18%. Early-phase studies and advanced therapy medicinal products have been particularly affected. Against this backdrop, FAST-EU represents a concrete effort to restore Europe's attractiveness for clinical research investment.

This complements national initiatives for mononational clinical trials, such as the French fast track process launched in December 2025.

Scope

This accelerated process will apply to selected multinational clinical trials, with a focus on those involving a high number of EU Member States. Other considerations such as prior engagement in EU-level pre-assessment activities will also be considered.

In addition, there will be national initiatives for mononational clinical trials. For instance, mononational clinical trials conducted in France, falling into one of the following categories, will benefit from a fast-track process:

• early-phase clinical trials (Phase I or I-II); and
• mononational clinical trials meeting at least one of the following criteria:
  • targeting serious, rare, or disabling diseases with no appropriate available treatment; and/or
  • investigating a first-in-class therapy, based on an entirely novel mechanism of action; and/or
  • facilitating the inclusion of adolescents in adult clinical trials, where scientifically and ethically justified.

New timelines

Under FAST-EU, the HMA has committed to "clear and ambitious timelines" for eligible multinational clinical trials, with operational details expected in the coming weeks. Early indications suggest authorisation periods could be reduced to approximately 70 days for compliant dossiers. For mononational clinical trials in France, the ANSM has confirmed that authorisation may be granted within 14 days where no requests for information are raised, or within 49 days where clarifications are required.

In practice, requests for clarification from regulatory authorities and/or ethic committees are frequent; dossier quality and anticipated Q&A readiness will be key to realising the shortest timelines.

Pilot

Both the EU and national fast-track systems will be subject to a trial phase / pilot before broader implementation and rigorous standards will be maintained for patient safety and scientific quality.

Wider context

This initiative echoes a broader policy direction at EU level. The Draghi report on European competitiveness highlights the need for regulators to strengthen the EU’s attractiveness for clinical research and to shorten pathways for the development and market access of innovative medicines. Against this backdrop, the EU and national fast-track schemes can be seen as a concrete national contribution to these objectives. The HMA stresses the fact that "in contrast to other regions in the world Ethics Committees' opinions […] are already built into this ambitious process".

More generally, the fast-track fits within a wider set of European regulatory developments aimed at enhancing the competitiveness of the EU life sciences ecosystem:

• European Health Data Space (EHDS). Now formally adopted, the EHDS will progressively establish harmonised frameworks for the secondary use of health data across the EU. Once fully implemented, it is expected to facilitate access, under regulated conditions, to high-quality health data for research and innovation purposes, including clinical development.
• Reform of EU pharmaceutical legislation. These legislative reforms include proposals to better accommodate highly innovative medicinal products, notably through regulatory sandboxes and other flexibility mechanisms. While the final contours remain subject to the publication of the final texts, these tools may, in due course, allow for more adaptive approaches to clinical development in well-defined cases.
• Biotech Act. As further explained in another blog, the Biotech Act could improve the clinical trials framework in the EU by encouraging the use of digital tools and decentralized trial models to further enhance the structure of clinical trials.
  

Actions to implement: 

Sponsors should consider the following steps:

• Assess pipeline eligibility. Review ongoing and planned clinical development programmes to identify trials that may qualify for FAST-EU or national fast-track pathways. Trials involving multiple EU Member States, early-phase studies, and programmes targeting serious diseases with unmet needs are likely candidates.
  
• Participate actively in the pilots. Engagement in the pilot phase offers a dual benefit: accelerating individual projects while contributing to the refinement of these procedures. Sponsors should designate a regulatory lead to monitor HMA and EMA communications on eligibility criteria and application modalities, which are expected in the coming weeks.

This could in turn influence broader investment decisions, as the EU becomes increasingly competitive for first-in-human and proof-of-concept studies.