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The UK regulator approved cell and gene therapies faster than the FDA on three of the last five comparable filings.
The MHRA cleared 84 clinical trial applications in its first 60-day window last year – and Lawrence Tallon wants the next 60 days to look nothing like that.
As CEO of the Medicines and Healthcare products Regulatory Agency, Tallon is rebuilding how the UK approves new medicines: collapsing the 30-day and 60-day clocks, leaning into the recently announced US-UK pharmaceutical deal, and reorganising the MHRA around speed without trading off safety. The agency's April 2026 reform package – the largest in more than 20 years – cut combined safety-and-ethics set-up times from 169 days to 122 days, and a pilot of the new Route B amendment pathway is averaging seven days against a 14-day threshold. ATMP timelines are starting to bend the same way: faster clinical trial approvals, the International Recognition Procedure for FDA-approved products, and Tallon's stated ambition of making the UK a Tier 1 trial destination by the end of the decade.
At Meeting on the Med 2026, reporting for Onyx, Federico Citterich sat down with Lawrence Tallon to find out more.
A special thanks to our Onyx Live sponsors:
Cellares - delivering cell therapy manufacturing excellence at scale across a global network of IDMO smart factories https://www.cellares.com/
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