UK Clinical Trial Approval Times Halved with AI and Regulatory Reforms

10th October 2025

UK Clinical Trial Approval Times Halved with AI and Regulatory Reforms

Summary: The Medicines and Healthcare products Regulatory Agency (MHRA) has implemented significant reforms, including the integration of artificial intelligence (AI) and streamlined regulatory processes, to expedite clinical trial approvals. According to a study published in the British Journal of Clinical Pharmacology, 99% of applications are now reviewed within statutory timelines, with many completed ahead of target. A fast-track route allows some lower-risk studies to be approved in just 14 days, accelerating patient access to treatments. AI tools assist assessors by reviewing complex data and improving consistency, while final decisions remain with experienced professionals to ensure patient safety. These reforms are part of the government's broader efforts to modernize the UK's research landscape, aiming to reduce clinical trial setup times to under 150 days by March 2026.

Link: UK Clinical Trial Approval Times Halved with AI and Regulatory Reforms

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