Overview

• A British Journal of Clinical Pharmacology study of more than 4,600 applications reports average approval times fell from 91 to 41 days with 99% completed within statutory timelines.
• The regulator’s risk‑proportionate approach and Combined Review with the Health Research Authority run ethical and regulatory assessments in parallel, including a 14‑day notification route for lower‑risk studies that enabled an earlier start for a haemophilia A trial.
• MHRA is deploying assessor‑support AI, including the Knowledge Hub to surface recurring issues and a GMP Compliance Checker to verify manufacturing documents in seconds, with final decisions remaining human‑led.
• Legislation scheduled for April 2026 will require public trial registration and result publication with plain‑language summaries and will extend sponsor response windows from 14 to 60 days.
• The agency highlights ongoing priorities to improve trial diversity and address under‑represented conditions to strengthen the UK’s research appeal.