Key Summary
- The MHRA has increased the efficiency of regulation and helped attract innovation and investment in the UK’s thriving £100 billion life sciences industry.
- It has ended the year in financial surplus, which reflects improved stability and disciplined operational delivery.
- It is collaborating with the US Food and Drug Administration on medical device regulation.
The Medicines and Healthcare products Regulatory Agency (MHRA) has said that it has met or exceeded all statutory targets to increase access to medicines and medical devices for UK patients during the 2025/2026 financial year.
According to the MHRA Results and Forecast report published on Tuesday (28), the regulator has delivered against every statutory commitment, meeting all key performance indicators with excellent on-time performance across licensing, clinical trials, and safety decisions.
It continues to speed up access to medicines for patients, increase efficiency of regulation, and help attract innovation and investment in the UK’s thriving £100 billion life sciences industry.
MHRA has strengthened patient and public safety by tackling health misinformation, introducing stronger post-market surveillance rules for medical devices, removing nearly 28 million unauthorised medicine doses and modernising safety monitoring through enhanced vigilance systems.
It has ended the year in financial surplus, which reflects improved stability and disciplined operational delivery.
The year also saw increased staff engagement, with record participation in the staff survey, and a significant improvement in the Engagement Score, reflecting a more motivated and growing workforce.
Global tie-ups
The regulator has also strengthened its position as a world-leading medicines regulator by striking new global partnerships and advancing pioneering work in clinical trials reform, AI regulation, and rare disease therapeutics pathways.
This includes a new UK–Singapore Innovation Corridor, inaugural membership of the HealthAI network and collaboration with the US Food and Drug Administration (FDA) on medical device regulation as part of the wider US-UK pharmaceutical partnership.
Ambitious plans
Building on this strong performance, the MHRA will launch a new five-year strategy later this year, setting out how UK regulation will continue to evolve to support patient safety, NHS priorities, scientific innovation, and economic growth in the UK life sciences sector through to 2030.
Tangible progress
Health minister Dr Zubir Ahmed, said, “This past year has shown what a modern regulator looks like: patients first, pace where it matters, and standards that never slip.
"The MHRA has made tangible progress on this Government’s ambitions for the NHS, public health, and the Life Sciences Sector Plan.
"The direction of travel is clear. With the MHRA operating as a high-performance regulator, the UK is positioned as a global destination for life sciences that is open to innovation, serious about safety, and credible on the world stage.”
MHRA chief executive Lawrence Tallon said, “We have a regulatory environment that’s scientifically rigorous, agile and has patients at its heart. Whether it’s enabling access to the next generation of medicines and health technologies or protecting patients from harm, our success is measured not just in frameworks and timelines, but in improved lives."
MHRA chair Professor Anthony Harnden said, “This progress is the result of the skill, professionalism, and commitment of MHRA staff across science, regulation, digital, policy and services.
“Working across the UK health system with researchers, industry, and international counterparts, I have seen first-hand how collaboration strengthens regulation and accelerates access to safe innovation.
Medicines UK lauds MHRA
Medicines UK has congratulated Lawrence Tallon and his team for delivering their fastest performance in terms of licensing medicines in a decade.
In a LinkedIn post, Medicines UK said, "The UK is not automatically guaranteed access to all the medicines it needs. As a standalone market outside the EU, we now compete for finite global supplies of essential medicines.
"The NHS depends heavily on generics and biosimilars - they account for 85 percent of all prescriptions.
"Around a quarter are manufactured here, with the rest coming predominantly from Europe and India, supported by supply chains that stretch across to China.
"In this context, the UK’s operating and commercial environment matters enormously. Manufacturers will prioritise markets that are predictable, efficient and commercially viable. Regulatory performance is a central part of that equation."
The generic drugs manufacturers' body said they have been evaluating MHRA's performance over the year and regulatory delays and licensing backlog have been major issues in the past.
"It was highly encouraging to see the backlog cleared in early 2025. The agency deserves real credit for that achievement," it added.
Medicines UK said its latest survey shows that national new product approval times are the best in a decade.
"Currently, 90 percent of applications are approved within 12 months, with the remainder completed within 12–15 months - a return to pre‑Brexit levels of predictability.
The International Recognition Procedure is delivering speed and consistency, with 85 percent of applications are completed in under three months, when based on EU approval.
All of this is being achieved while submission volumes have risen by 30–50 percent in some months, it added.
"There is still more to do - and industry has a role to play, including better use of horizon‑scanning tools. But the direction of travel is positive," Medicines UK said.
