MHRA launches pilot programme to incentivise low-risk Phase I clinical trials in healthy adult volunteers

Overview

The UK’s MHRA has launched a pilot programme to significantly speed up the approval of certain low-risk Phase 1 clinical trials in healthy adult volunteers. The goal is to reduce the first-cycle MHRA review time from the standard 30 days to just 14 calendar days by the end of 2026.

This initiative responds to industry and government calls for faster clinical trial start-ups in the UK while maintaining high safety and quality standards. It aims to make the UK more competitive for early-phase research.

Key Benefits for Sponsors

• Faster initial regulatory decision (target 14 days by end-2026).
• Greater predictability once an application is validated and accepted into the pilot pathway.
• Potential to accelerate first-in-human data generation in a high-quality regulatory environment.

Eligibility – Strictly Defined

The pilot is only for low-risk Phase 1 healthy volunteer trials (HVTs). Sponsors must self-assess using an official checklist.

Must meet all inclusion criteria, including:

• Phase 1 healthy volunteer trial only
• Satisfactory prior clinical safety data
• All proposed doses already shown to be safe and tolerable in previous human studies
• No major safety signals from prior human exposure

Automatic exclusions (examples):

• First-in-human (FIH) trials
• Advanced Therapy Medicinal Products (ATMPs)
• Complex trial designs (basket, umbrella, platform, MAMS)
• Trials involving medical devices, IVDs or companion diagnostics
• Novel mechanisms with complex pharmacology
• Multiple active IMPs (except certain bioequivalence studies)
• Non-GLP pivotal non-clinical data from non-OECD MAD countries

How the Pilot Works

1. Sponsor confirms eligibility with the official checklist.
2. Aligns with HRA fast-track ethics review.
3. Pre-books a limited submission slot by emailing the Agency
4. Submits the CTA via IRAS on the allocated date, clearly referencing the pilot and including the eligibility checklist.
5. After validation, the accelerated assessment clock starts.

Slots are limited and allocated on a first-come, first-served basis.

Timeline of the Pilot (2026)

The programme is rolling out in stages with increasing speed and capacity:

• Q1 2026: 28-day review, limited slots
• End Q2 2026: 21-day review
• End Q3 2026: 18-day review
• End Q4 2026: 14-day review, up to 16 slots per month

The pilot runs throughout 2026, with the full 14-day target applying from late December 2026.

Important Practical Notes

• High-quality, complete submissions are essential. Incomplete dossiers risk losing the fast-track slot.
• Validation can take up to 7 calendar days before the pilot clock starts.
• This is a controlled pilot with limited capacity; not every eligible trial will secure a slot.
• The accelerated pathway covers only the first MHRA assessment decision.

Bottom line
If you have a low-risk Phase 1 healthy volunteer study (not first-in-human or complex), the UK now offers a genuine opportunity for significantly faster regulatory review. Early planning, strict eligibility checking, and proactive slot booking will be critical to taking advantage of this pathway.