FAST-EU: A New Era for Multinational Clinical Trials in Europe

Europe has entered a pivotal moment in the evolution of its clinical research ecosystem. The launch of the FAST‑EU (Facilitating and Accelerating Strategic Clinical Trials in the EU) pilot on 30 January 2026 marks one of the most ambitious reforms since the Clinical Trials Regulation (CTR) came into force. Backed by the Heads of Medicines Agencies (HMA), the Clinical Trials Coordination Group (CTCG), and MedEthicsEU, FAST‑EU introduces a new framework designed to increase predictability, strengthen coordination, and accelerate decision‑making for multinational clinical trial applications. This initiative reflects a proactive effort by EU authorities to create a more coherent, modern, and responsive regulatory environment capable of supporting the next generation of complex and innovative clinical studies.

FAST‑EU launches at a strategically significant time, aligning with broader EU efforts to modernise the regulatory landscape and enhance competitiveness in biotechnology and clinical development. Alongside the European Biotech Act, the pilot signals a clear commitment to reducing procedural complexity, shortening development timelines, and demonstrating that Europe can operate swiftly and cohesively across its Member States.

Why FAST‑EU Matters

Although the EU’s CTR was introduced to harmonise and streamline clinical trial approvals across Member States, many sponsors still encounter fragmented processes, inconsistent timelines, and variations in how requirements are interpreted. For complex multinational studies, these issues can create delays that impact both patient access to innovative therapies and broader strategic investment decisions.

FAST‑EU aims to directly address these challenges by:

• Improving predictability and efficiency of assessment timelines
• Strengthening coordination between National Competent Authorities and Ethics Committees
• Testing more ambitious internal deadlines with a parallel review model
• Demonstrating the feasibility of rapid, pan‑EU regulatory collaboration

FAST‑EU introduces an ambitious 70-day assessment window (approximately 10 weeks), from clinical trial application (CTA) to Part I and Part II conclusions, including sponsor response time. Validation, Part I, and Part II assessments occur in parallel, a departure from the more sequential rhythms of the standard CTR pathway.

Eligibility and Scope

The FAST‑EU applies to initial CTAs for multinational clinical trials (across more than one EU Member State) involving any investigational medicinal product, including small molecules, biologics, ATMPs, and combination products. The pilot operates entirely within Clinical Trials Information System (CTIS) and does not alter any existing legal obligations under the CTR. Its only distinction is the shortened assessment timelines, allowing Member States to explore more agile and efficient evaluation processes while maintaining regulatory integrity.

To manage workload and generate high‑quality learning, participation is limited to two trials per month, allocated through curated weekly submission slots to balance workload across Reporting Member States (RMS) and Member States Concerned (MSCs).

Selection considers:

• Number of MSCs involved
• Suitability and availability of the proposed RMS
• Medical relevance and complexity of the trial
• Prior EU‑level engagement (e.g., EMA Scientific Advice, PRIME)

• Overall workload and capacity across participating MSCs

This is not a first‑come, first‑served process but a curated pilot designed to test system performance under controlled conditions. Criteria may be adapted as experience is gained.

How to Apply (Letter of Intention)

Participation starts with submission of an expression of interest via email or Eudralink using a Letter of Intention (LoI). The LoI is not a pre‑submission review but an allocation request signalling readiness.

The LoI should:

• Summarise key trial details: EU CT number, protocol code, title, design, phase, population, objectives (or a concise synopsis)
• Describe the IMP(s)
• Identify Member States involved
• Propose an RMS (plus acceptable alternatives)
• Note prior EMA Scientific Advice/PRIME interactions
• Specify the relevant National Ethics Committee
  (A LoI template is available in Annex I of the FAST-EU Sponsor Guide)

Importantly, at the time of the LoI submission, the sponsor must ensure that the full CTA dossier is ready (per Annex I of the CTR), as the CTA submission is expected within two days of slot allocation. This early‑stage clarity is meant to support both sponsor preparation and regulatory predictability.  

The agency typically responds within five working days of the request, confirming slot allocation, the expected CTA submission date, and the final RMS assigned. As under the CTR, the RMS proposed by the sponsor is non‑binding, and an alternative RMS may be assigned. If a slot cannot be allocated or if the sponsor cannot meet the submission date, the sponsor can proceed under the standard CTR pathway. Non‑selection or non‑participation in the FAST‑EU pilot has no regulatory consequence for a subsequent CTA submitted via the conventional procedure.

Roles and responsibilities of RMS and MSCs in the Fast-EU pilot

The RMS coordinates the FAST‑EU procedure, serving as the sponsor’s main contact, overseeing and enforcing the pilot timelines, consolidating validation (Part I and II) and Part I assessment considerations, managing Requests for Information (RFIs) (Validation and Part I assessment), and triggering any fallback to standard CTR timelines where required.

Participating MSCs conduct Part I and Part II validation and assessment within FAST‑EU timelines, contribute to RFIs and response review and retain full responsibility for Part II assessment and their national decisions per CTR.

FAST‑EU Timelines at a Glance

Under FAST‑EU, the assessment of Validation, Part I, and Part II is carried out concurrently within a 70-calendar days window starting from CTA submission (Table 1). It incorporates a streamlined RFI structure allowing for:

• One consolidated validation RFI
• One Part I RFI
• One Part II RFI per MSC

Due to the compressed schedule, additional RFI rounds are unlikely, making high-quality initial submissions and timely responses crucial. At the conclusion of the FAST‑EU procedure, each MSC issues its national decision in accordance with CTR timelines.

 Table 1: CTA assessment timelines under FAST-EU pilot

What FAST‑EU Means for Sponsors

While participation is voluntary, FAST‑EU offers sponsors a unique opportunity to test a faster, more coordinated regulatory pathway, particularly valuable for innovative therapies requiring broad geographic enrolment and accelerated development cycles.

Sponsors entering FAST‑EU should be prepared to:

• Submit complete, high‑quality dossiers
• Respond promptly to RFIs in line with CTR procedures
• Accept a potential fallback to standard CTR timelines if coordination becomes unfeasible

Importantly, fallback:

• Does not require resubmission
• Preserves all completed assessment work
• Allows seamless continuation under standard CTR timelines

Thus, participating in FAST‑EU carries minimal regulatory risk.

Alignment with the European Biotech Act

FAST‑EU is not part of the legislative proposal but is strategically aligned with the Biotech Act’s objectives, including:

• Improved regulatory predictability
• Shorter and more stable timelines
• Stronger cross‑Member State coordination
• Reduced administrative burden

Notably, while the Biotech Act introduces differentiated global and national Part I elements, these cannot yet be piloted due to CTIS limitations. Instead, FAST‑EU observes and documents national Part I considerations to inform future implementation.

The Broader Implications for the EU Clinical Trial Landscape

FAST‑EU is not only about accelerating individual applications, but it also acts as a structured learning and evidence-based exercise to test how an accelerated EU review pathway could work in practice. The pilot explores whether the EU can deliver faster, more coordinated decisions without compromising scientific, safety and ethical standards.

If successful, the pilot may guide future CTIS improvements, support EU Biotech Act rollout, strengthen RMS/MSC coordination, and help establish EU‑wide best practices for accelerated review. For industry, it underscores regulators’ growing commitment to more agile and globally competitive frameworks.

How Boyds Can Help

As Europe continues to reshape its clinical and biotech regulatory environment, sponsors will need clear strategies to navigate evolving pathways such as FAST‑EU and future Biotech Act reforms. Boyds provides end‑to‑end regulatory support across the clinical development lifecycle, including:

• Strategic eligibility assessment for FAST‑EU
• Preparation of Letters of Intention and slot‑allocation strategies
• CTIS‑ready dossier development
• RFI management under accelerated timelines
• Integration of emerging EU regulatory reforms into long‑term development plans

If you would like to discuss whether FAST-EU is right for your program or how to prepare for the EU’s evolving regulatory landscape, please get in touch with our experts.