Accelerating FAST-EU Clinical Trials

FAST-EU Clinical Trials Launch with 70-Day Target

The FAST-EU clinical trials pilot, known as Facilitating and Accelerating Strategic Clinical Trials in the EU, is a one-year voluntary initiative by the Heads of Medicines Agencies (HMA), Clinical Trials Coordination Group (CTCG), and MedEthics EU. It targets initial multinational clinical trial applications under the Clinical Trials Regulation (CTR, Regulation (EU) No. 536/2014), operating fully within the Clinical Trials Information System (CTIS). The process compresses to a maximum of 70 calendar days (10 weeks) from submission to Part I and Part II conclusions, including sponsor responses, via parallel validation and assessment workflows coordinated by a Reporting Member State (RMS). This acceleration upholds scientific, safety, and ethical standards while integrating Ethics Committee opinions across 25 participating EU/EEA Member States Concerned (MSCs).

Parallel Workflows Squeeze Timelines

FAST-EU clinical trials achieve the 70-day target through coordinated parallel processes starting at Day 0 of CTIS submission, with validation decisions by Day 21, Draft Assessment Reports (DARs) for Part I by Day 28, and final conclusions for both Parts I and II by Day 70. Sponsors submit a Letter of Intention via email to [email protected] using a templated Annex I form, detailing trial specifics like phase, design, investigational medicinal product (IMP) description, proposed RMS (with alternatives), and MSCs. They receive slot confirmation within 5 working days for up to two trials monthly. The RMS consolidates Requests for Information (RFIs)—a single round each for validation (by Day 7, response by Day 14), Part I (DAR by Day 28, response by Day 54), and Part II (initial by Day 42, response by Day 54)—while MSCs handle national Part II assessments and decisions per CTR timelines. Fallbacks to standard CTR timelines ensure no loss of work, delivering full legal CTR decisions without altering sponsor obligations or CTIS requirements.

Slot Prioritization for High-Impact Trials

Pilot selection prioritizes multinational FAST-EU clinical trials with finalized CTIS dossiers ready within two working days of slot confirmation, favoring high MSC numbers, suitable RMS availability, trial complexity balanced against prior European Medicines Agency (EMA) engagements like Scientific Advice or PRIME, and authority workloads. Governance assigns clear roles: RMS enforces timelines and RFIs; MSCs perform assessments; the EMA-hosted coordination office manages administrative support and queries; and the CTCG/MedEthics EU-chaired Selection Committee ensures trial relevance for Biotech Act insights, with final RMS decisions. This excludes mono-national trials, resubmissions, or substantial modifications, focusing on innovative IMPs across chemical, biological, or advanced therapy medicinal products (ATMPs).

Boosting Health Economics via Faster Approvals

The FAST-EU clinical trials pilot accelerates multinational timelines, enabling faster patient recruitment, robust evidence generation, and earlier European involvement in innovative product development. This informs market access, pricing, and reimbursement strategies, potentially reducing development costs and time-to-market versus standard CTR durations. Enhanced cross-MSC coordination suits complex trials in priority indications, aligning with objectives of the EU Biotech Act.