Guidance: 14-day assessment stepwise implementation programme for Phase 1 clinical trials
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The programme is a targeted MHRA initiative to speed up approvals for certain low-risk Phase 1 trials. We aim to deliver the first wave 1 regulatory assessment in 14 calendar days for qualifying applications by the end of 2026.
This accelerated programme was introduced in response to stakeholder and government calls for faster clinical trial start-ups, while using a controlled, evidence-based approach to maintain high safety and quality standards.
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- https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency.atom ATOM
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- September 30, 2026 15:00
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https://www.gov.uk/government/publications/14-day-assessment-stepwise-implementation-pr...