Fast, Expert and Open – how the MHRA is poised to become a global leader in risk-proportionate regulation
Source: gov.uk (2025-06-18)

New MHRA CEO puts safety, accelerated access and innovation at the centre of agency’s refreshed strategic direction.

New MHRA CEO and other senior leaders from the UK Medicines and Healthcare products Regulatory Agency (MHRA) have set out the agency’s refreshed strategic direction at DIA Global in Washington DC, 17 June 2025.

Speaking to DIA Global delegates, MHRA CEO Lawrence Tallon said:

“If I were to summarise our emerging strengths, I’d say we are increasingly fast, expert and open.

“By this, I mean we put patients first and can be relied on to apply our expertise quickly, innovatively and in collaboration with our rich network of partners across the UK healthcare system as well as globally.

“We will now capitalise on our strengths to cement the UK as global leader in risk-proportionate regulation by setting out a clear and focused strategic direction.”

The strategic aims laid out by the MHRA at today’s event are:

Patient and public safety: To build a world-class safety and surveillance system enabled by comprehensive real-world data for the protection of patients and the public.

Accelerated access: To accelerate access to new medicines, medical products and technologies with rapid, efficient decisions on clinical trials and core licensing.

10X innovation: Driving up the MHRA’s contribution to UK life sciences for the benefit of the public, the NHS and economic growth.

Dr Alison Cave, MHRA Chief Safety Officer said:

“It is absolutely vital that patient and public safety continues to underpin the MHRA’s strategic focus.

“Already, 95% of urgent adverse reaction reviews for medicines and medical devices completed in 24 hours and 100% in 5 working days.

“Underpinned by our data strategy, our priority now is to take advantage of new analytical methods to drive innovation in safety surveillance to strengthen patient safety even further.”

Julian Beach, MHRA Interim Director of Healthcare Quality and Access said:

“Our latest performance data shows our approval decisions are made on time, every time.

“Our focus now is on capitalising on our national decision-making ability with new guidance that will enable innovation in new and existing areas, and enhancing our collaborative working with NICE to provide a new joined-up licensing and guidance pathway.

“Critical to this is working with international partners to establish the best outcomes for patients in the UK.”

James Pound, Interim Executive Director of Innovation and Compliance said:

“I see three key pillars for success in this next chapter.

“We must continue to cement the UK as a research powerhouse through our world-class infrastructure, research base and rapid approvals.

“We must move upstream – positioning the MHRA as an engine of innovation to help get cutting-edge new treatments and technologies to patients and the NHS faster.

“And we must turbocharge the AI revolution in healthcare, in medical devices and in driving efficiencies in our own risk-proportionate processes.”

MHRA Executives have led a number of events across DIA Global 2025, including on the future of pharmacovigilance, on use of AI across the product lifecycle and on applying principles of global regulatory collaboration to address chronic disease.

Notes to editors:
- The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health and Social Care.
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