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.”
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.