FAST-EU Pilot: Can Europe Finally Accelerate Multinational Clinical Trials?

The FAST-EU Pilot represents one of Europe’s most significant clinical trial reforms since the implementation of the Clinical Trials Regulation (CTR).

Designed to shorten the start-up of multinational Phase II and III clinical trials, the initiative aims to make Europe a more attractive destination for global pharmaceutical research by introducing a coordinated, expedited assessment process across participating EU Member States.

While the pilot is still in its early stages, it demonstrates a broader shift in how European regulators intend to achieve their Accelerating Clinical Trials in the European Union (ACT EU) ambitions and meet the region’s 2030 clinical trial targets.

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Why Europe Is Changing its Approach to Clinical Trials

Europe remains one of the world’s largest pharmaceutical research markets, yet sponsors have increasingly highlighted the complexity of launching multinational studies across multiple countries.

Although the EU Clinical Trials Regulation (CTR) and Clinical Trials Information System (CTIS) significantly improved harmonisation after their introduction, sponsors continue to face lengthy start-up timelines, differing national expectations, and operational complexity when activating multicountry studies.

The FAST-EU Pilot seeks to address these issues.

Rather than changing the legislation itself, the programme introduces an accelerated and coordinated assessment pathway for selected multinational clinical trials.

The objective is simple: Reduce administrative delays without compromising scientific quality, patient safety, or regulatory oversight.

The initiative forms part of the broader ACT EU programme, a collaboration between the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA), and the European Commission to improve Europe’s competitiveness in clinical research.

What Is the FAST-EU Pilot?

The FAST-EU Pilot is a voluntary initiative involving several European national competent authorities working together to provide expedited assessment of eligible multinational clinical trial applications submitted through CTIS.

Unlike the standard process, participating regulators commit to closer collaboration and shorter review timelines for selected studies.

The pilot initially focuses on:

• multinational Phase II and Phase III interventional clinical trials
• commercially sponsored studies
• multinational academic trials where eligibility criteria are met
• studies involving multiple participating EU Member States

The programme is not intended to replace the Clinical Trials Regulation.

Instead, it builds on the existing framework by improving coordination between regulators before and during assessment.

Sponsors submit applications through the established CTIS platform, while participating authorities work together to streamline communication and minimise duplication.

For pharmaceutical companies, this creates the potential for faster trial activation across multiple European markets without introducing an entirely new regulatory pathway.

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Supporting Europe’s 2030 Clinical Trial Ambitions

FAST-EU is not an isolated project and forms only one component of the ACT EU workplan, which aims to make Europe a global leader in clinical research by 2030.

According to recent progress updates from the EMA, ACT EU focuses on three strategic objectives:

Making Europe more attractive for clinical research

Global competition for clinical trials has intensified.

Sponsors increasingly compare Europe with regions including the U.S. and Asia when selecting development locations.

Reducing administrative burden while maintaining high scientific standards is viewed as essential if Europe is to remain competitive.

Accelerating study start-up

Long activation timelines increase development costs and delay patient access to innovative medicines.

By improving coordination between participating regulators, FAST-EU aims to shorten the period between application submission and trial initiation.

Strengthening multinational collaboration

Many modern clinical trials involve dozens of countries.

The pilot encourages participating EU Member States to work together more consistently, creating a more predictable experience for sponsors running multinational programmes.

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Why Faster Assessments Matter in Pharmaceutical Development

Clinical development remains one of the longest and most expensive stages of bringing a medicine to market.

While discovery programmes increasingly benefit from AI, automation, and digital technologies, regulatory start-up timelines often remain difficult to predict.

Every month of delay can affect:

• patient recruitment
• development costs
• competitive positioning
• patent life
• commercial launch timelines

Although the FAST-EU Pilot does not change the scientific evidence required for approval, it aims to improve the efficiency of the assessment process itself.

For sponsors managing global development programmes, greater predictability may prove just as valuable as shorter review periods.

A Coordinated European Pharma Review Model

One of the pilot’s most important features is the emphasis on collaboration rather than acceleration alone.

Participating authorities aim to align scientific discussions earlier during the review process, reducing duplicated questions and limiting unnecessary administrative exchanges.

Rather than each EU Member State working independently, European regulators are increasingly adopting network-based assessment models that share expertise while preserving national responsibilities.

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If successful, the FAST-EU pilot could demonstrate how coordinated regulatory science improves operational efficiency without lowering regulatory standards.

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Which Countries are Participating in the FAST-EU Pilot?

The pilot launched with participation from several European medicines agencies, including regulators from:

• Germany
• Denmark
• Ireland
• Spain
• France
• Italy
• The Netherlands
• Sweden
• Norway

Additional EU Member States may participate as the programme evolves.

The pilot remains voluntary for both sponsors and national authorities, allowing regulators to evaluate performance before considering wider implementation.

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Success Depends on More than Faster Timelines

Although the objectives are widely supported, FAST-EU should be viewed as an operational pilot rather than a complete transformation of European clinical trials.

Several practical questions remain:

Capacity

Expedited assessments require sufficient regulatory resources.

If application volumes increase substantially, participating agencies will need adequate staffing to maintain accelerated timelines without affecting review quality.

Consistency

One of the programme’s long-term goals is greater consistency between EU Member States.

Delivering this consistently across multiple regulators will require continued collaboration and shared experience.

Measuring outcomes

Ultimately, success should be measured by more than review speed.

Sponsors will also evaluate:

• predictability of timelines
• quality of regulatory interaction
• reduction in administrative burden
• trial activation rates
• Europe’s attractiveness for global development programmes

These broader indicators may prove more important than individual assessment timelines alone.

Early Results Suggest Strong Industry Momentum

Although the FAST-EU Pilot only launched in February 2026, its first interim results indicate strong demand from sponsors and demonstrate that accelerated multinational clinical trial assessments are already achievable within the existing Clinical Trials Regulation (CTR) framework.

In its first three months, the FAST-EU Coordination Office received 68 Expressions of Interest from pharmaceutical companies and academic sponsors across Europe and internationally.

From these, 15 multinational clinical trials were selected for the pilot, significantly exceeding the programme's original capacity of two procedures per month.

The selected portfolio spans Phase I to Phase III studies and covers a diverse range of therapeutic areas, including oncology and haematology (seven trials), neurology and neurodegenerative diseases (two), cardiovascular and pulmonary vascular disease (two), and immunology and inflammatory diseases (two).

On average, each study involves 7 participating EU Member States, with one trial spanning 14 countries, highlighting the programme's ability to support complex multinational development programmes.

The pilot has also demonstrated that accelerated regulatory timelines are achievable.

By May 2026, the first three multinational assessments had been completed within, or effectively within, the FAST-EU target of 70 calendar days, providing early evidence that coordinated reviews can be delivered without compromising scientific, ethical, or patient safety standards.

Participation has expanded to 26 EU and EEA countries, with reporting EU Member State responsibilities already distributed across regulators including Italy, Denmark, Germany, the Netherlands, Finland, Poland, Sweden, Spain, Belgium, Norway, and the Czech Republic, while additional countries, including Romania, Hungary, Austria, and Portugal, are scheduled to lead future assessments.

Collectively, these early milestones suggest that FAST-EU is not simply a policy initiative, but a practical demonstration that Europe can deliver faster, more coordinated clinical trial authorisations while supporting the objectives of the proposed EU Biotech Act and the broader ACT EU strategy.

Could FAST-EU reshape Europe’s clinical research landscape?

The pharmaceutical industry has consistently called for greater efficiency across multinational clinical development.

FAST-EU represents an important step towards addressing that challenge.

Rather than introducing new legislation, the initiative seeks to improve how existing regulatory systems operate through closer collaboration, coordinated scientific assessment, and more predictable timelines.

The FAST-EU Pilot success will depend on whether participating regulators can demonstrate measurable improvements for sponsors while maintaining Europe's internationally recognised standards for patient safety and scientific rigour.

If those objectives are achieved, the FAST-EU pilot may become an important model for the next phase of ACT EU and help position Europe as a more competitive destination for global clinical research.

The FAST-EU Pilot is an early indication of how European clinical trial oversight may evolve over the remainder of this decade.

At Pharmatica, we analyse the policies, technologies, and operational strategies shaping modern clinical development. By connecting regulatory initiatives with their commercial and scientific implications, we help life sciences leaders make informed decisions in an increasingly competitive global research environment.

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