The pilot is a targeted MHRA initiative to speed up approvals for certain low-risk Phase 1 trials. The pilot aims to deliver the first wave 1 regulatory assessment in 14 calendar days for qualifying applications by the end of 2026.
This accelerated pathway 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.
By piloting a two-week assessment timeline for suitable trials, the MHRA seeks to boost the UK’s competitiveness in early-phase research and encourage sponsors to run more Phase 1 studies in the UK.
Excerpt from the official page. The original is authoritative.