The Medicines and Healthcare products Regulatory Agency (MHRA) met or exceeded all statutory targets to increase access to medicines and medical devices for UK patients, according to the MHRA Results and Forecast report published today (28 April).
The MHRA has 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. It continues to speed up access to medicines for patients, increase efficiency of regulation and help to attract innovation and investment in the UK’s thriving £100 billion life sciences industry.
It continues to speed up access to medicines for patients, increase efficiency of regulation and help to attract innovation and investment in the UK’s thriving £100 billion life sciences industry.
Building on this strong performance over the last year, 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.
The MHRA Results and Forecast report shows that in the 2025/2026 financial year, the MHRA
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Strengthened patient and public safety
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.
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Hit all its performance targets
Delivering against every statutory commitment, meeting all key performance indicators with excellent on-time performance across licensing, clinical trials, and safety decisions.
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Ended the year in financial surplus
Closing the year in a strong financial position, achieving a healthy surplus that reflects improved stability and disciplined operational delivery.
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Led in key areas of regulatory science
Strengthening global leadership in regulatory science, investing in AI, in-silico research, and innovative methodologies, while advancing pioneering work in clinical trials reform, AI regulation, and rare disease pathways.
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Built closer national and international partnerships
Strengthening collaboration across the UK and globally, including the MHRA–National Institute for Health and Care Excellence’s (NICE) aligned pathway to accelerate patient access, 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.
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Enjoyed an increase in external sentiment
Demonstrating a sustained improvement in external perception, with independent research showing more positive views among industry, partners, and system stakeholders over the past 12–18 months.
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And also a rise in staff morale
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.
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 regulaor, 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.”
Lord Vallance, Minister for Science, Innovation, Research and Nuclear, said
“A strong life sciences sector depends on a regulator that is trusted by patients, by clinicians and by innovators. The MHRA is demonstrating that trustworthiness through its commitment to delivering for the NHS, public health, and economic growth. The MHRA’s progress and future direction strengthens the UK’s proposition as a global destination for research and development.”
Lawrence Tallon, MHRA Chief Executive, 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.
“With every performance target met, a strong financial position and more innovative medicines reaching patients, this is high quality regulation in practice. It is testament to the dedication of our committed and expert workforce and the strong partnerships we have with the wider UK and global health and life sciences system.”
Professor Anthony Harnden, MHRA Chair, said
“Over the past year, the MHRA has demonstrated what regulatory excellence looks like in practice. 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.
“Globally, the MHRA’s contribution to regulatory science is well respected. Our leadership and trusted standards support health systems worldwide. As we look ahead, the MHRA enters the next chapter confident and ambitious that we are a regulator the public can trust and the world can rely on.”
Stakeholder quotes
Jane Wall, Managing Director of the BioIndustry Association (BIA) said
“The MHRA’s strong performance over the past year reflects a regulator that is listening and evolving. The forward-looking initiatives showcased in this report – including the development of a new rare disease pathway – highlight the value of collaborative working to accelerate innovation and delivering better outcomes for patients acrand delivering better outcomes for patients across the UK. We look forward to continuing to collaborate closely with the MHRA to build on this momentum.”
Professor Jonathan Benger, CBE MD FRCS FRCEM, Chief Executive of the National Institute for Health and Care Excellence (NICE) said
“Continuing improvements to joint working between NICE and the MHRA are creating a more integrated and frictionless pathway from regulation to patient access. By aligning our expertise earlier and more closely, we can support innovation, reduce duplication, and provide clearer, faster routes for effective new medicines and technologies to reach patients sooner.”
Julia Vitarello, patient advocate and Founder of Mila’s Miracle Foundation, said
“For families like mine facing rare genetic diseases, progress is measured by how many sick and dying children can access today’s incredible technologies in time. The MHRA is truly leading the way through action, paving the world’s first pathway toward process-based approvals to meet the new very promising era of individualised medicines. If successful, the UK will prove a new bridge connecting patients in desperate need with the science that can save lives.”
Dr Matt Westmore, Chief Executive of the Health Research Agency (HRA), said
“One of the UK’s core strengths in health and care research is our joined up regulatory system. Through close partnership between MHRA, HRA and others, we have streamlined and simplified the approvals pathway. By reducing duplication and complexity we’re giving researchers a faster, more predictable experience from start to finish. I’m particularly proud of our work together on Combined Review which continues to go from strength-to-strength, helping patients access potentially life changing research sooner.”
Richard Torbett, Chief Executive, Association of the British Pharmaceutical Industry (ABPI), said
“Over the past year, the MHRA has continued to make important progress in strengthening the UK’s regulatory environment for medicines and vaccines, particularly in the provision of predictable and reliable services. Improved efficiency around clinical trial approvals, alongside enhanced safety surveillance is also helping to support earlier patient access to innovative medicines while maintaining robust regulatory standards. This progress is helping to boost the UK’s position as an attractive environment for life sciences research and earlier patient access. It is encouraging to see this momentum in the evolution of the regulatory system, and we hope to see it continue in the years ahead.”
Peter Ellingworth, CEO, Association of British Health Tech Industries (ABHI), said
“The MHRA’s outward-looking and collaborative approach is welcome, particularly its engagement with global partners to drive regulatory harmonisation. Greater alignment across markets will help reduce complexity and reinforce the UK’s position as a competitive destination for HealthTech innovation and investment. ABHI values its continued engagement with the MHRA and the opportunity to work together to deliver these important reforms.”
Lord O’Shaughnessy, former health minister, senior partner at Newmarket Strategy and author of the landmark report into the UK commercial clinical trials landscape said
“The progress made since I published my review in 2023 has been remarkable. The MHRA is now delivering consistently good approval times while introducing further reforms that are adding speed and flexibility to the process. The MHRA is once again taking a global lead, which is helping to attract more clinical trials to the UK.”
Michelle Riddalls OBE, CEO, PAGB, the consumer healthcare association shares
“Lawrence Tallon’s commitment to engaging and collaborating with industry associations has significantly advanced MHRA’s understanding of consumer healthcare priorities this year. His leadership has facilitated new opportunities to discuss practical and impactful ways to expand medicine reclassification and empower self-care.
“Reclassification is a key opportunity to expand access to medicines, support self-care, and reduce pressure on NHS services. MHRA has a real opportunity to accelerate this shift and, through initiatives like the Access Consortium, further drive international collaboration, and innovation.”
Dr Ricardo Baptista Leite, CEO, HealthAI – The Global Agency for Responsible AI in Health, said
“As the first pioneer country in the HealthAI Global Regulatory Network, the UK has helped turn responsible AI in health from a promise into a concrete global ambition. By coupling bold reform with a clear commitment to safety and equity, the MHRA is charting a path that can inspire innovators, regulators and investors worldwide to build AI-powered health systems that truly serve people.”
Steve Bates OBE, Executive Chair of the Office for Life Sciences said
“In the past year, we have seen the UK’s regulatory environment generating real excitement among international stakeholders. The MHRA has been central to this, driving innovation through more agile, responsive pathways.”
Adjunct Professor (Dr) Raymond Chua, Chief Executive Officer, Health Sciences Authority (HSA), Singapore, said
“Our longstanding partnership with the MHRA has strengthened through the launch of our Regulatory Innovation Corridor, and refreshed memorandum of understanding. As a globally connected biomedical hub, Singapore is committed to shaping a forward-looking regulatory environment with like-minded partners like the MHRA. Together, we are accelerating innovation in Singapore and the UK to to deliver transformative technologies to benefit patients, while upholding the highest standards of safety, trust, and excellence.”
Notes to editors
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The MHRA’s Results and Forecast is available at MHRA Results and Forecast 2025/26; 2026/27 – GOV.UK
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The Medicines and Healthcare products Regulatory Agency (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.
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The MHRA is an executive agency of the Department of Health and Social Care.
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