UK Clinical Trial Approvals Halved Through AI and Digital Reforms

TL;DR: The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has cut clinical trial approval times from 91 to 41 days using AI-powered digital platforms and risk-proportionate oversight, with 99% of applications now reviewed within statutory timelines.

The Medicines and Healthcare products Regulatory Agency (MHRA) has more than halved clinical trial approval times in the UK, reducing the average from 91 days to just 41 days through digital reforms backed by AI tools. Research published this week in the British Journal of Clinical Pharmacology confirms the reforms are delivering consistently strong results, with 99% of applications reviewed within statutory timelines.

Context and Background

The reforms, introduced in 2023, enable patients to access promising new treatments—from cancer therapies to rare disease studies—several weeks sooner than before. A fast-track route allows lower-risk studies to be approved in just 14 days, exemplified by a haemophilia A trial that began several weeks earlier than expected under the 14-day notification scheme.

Two bespoke AI tools are transforming the assessment process. The Knowledge Hub helps assessors identify common issues from past applications, enabling clearer guidance for trial sponsors. The GMP Compliance Checker verifies manufacturing documents in seconds rather than hours, freeing experts to focus on complex safety assessments. Digital dashboards provide real-time visibility across the UK’s entire trial portfolio, whilst the Combined Review process with the Health Research Authority runs ethical and regulatory assessments in parallel.

Looking Forward

The reforms support the Government’s 10 Year Health Plan and Life Sciences Sector Plan, with new legislation coming into force in April 2026. All UK clinical trials will be required to publicly register and publish results, including easy-to-read summaries for participants. The legislation will also extend the deadline for sponsors to respond to regulator feedback from 14 to 60 days, helping align with international trial timelines.

Health Minister Stephen Kinnock emphasised the shift from analogue to digital, stating that patients can now receive medicines in 41 days instead of 91, reinforcing the UK’s position as a global leader in clinical research whilst maintaining rigorous safety standards.

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