MHRA stepwise implementation programme – accelerating regulatory assessment

Date: 23 October 2026

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.

The two-week assessment timeline for suitable trials will boost the UK’s competitiveness in early-phase research and encourage sponsors to run more Phase 1 studies in the UK.

Find out more here: https://www.gov.uk/government/publications/14-day-assessment-stepwise-implementation-programme-for-phase-1-clinical-trials

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