Guidance

14-day assessment stepwise implementation programme for Phase 1 clinical trials

The stepwise implementation programme aims to deliver the first wave 1 regulatory assessment in 14 calendar days for qualifying applications by the end of 2026.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 17 August 2026
• Last updated: 30 September 2026
  Show all updates

  1. 30 September 2026

     1. The name of this programme has been updated from 14-day Phase 1 Clinical Trial Pilot Programme to the 14-day Assessment Stepwise Implementation Programme for Phase 1 Clinical Trials. This reflects the MHRA’s commitment to reduce assessment times for eligible trials to 14 days, by the end of December 2026. 2. The inclusion and exclusion criteria have been expanded to allow a wider range of trials to benefit from the programme: • Expansion of eligibility beyond healthy volunteer trials to include certain Phase 1 studies in non-oncology patients, where safety assessment is the primary objective. • Inclusion of bioequivalence (BE), drug-drug interaction (DDI), mass balance and QT studies within the eligible trial types. • Studies with up to three active investigational medicinal products (IMPs) are now included in the programme. • Exclusion of studies involving more than three active IMPs (with clarification that different strengths of the same formulation are not counted separately). • Studies involving more than one first-in-UK drug substance are excluded from the programme.

  2. 17 August 2026

     First published.

Documents

14-day assessment stepwise implementation programme for Phase 1 clinical trials

HTML

Details

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.