The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has 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 this week.
The MHRA said it 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.
Building on this strong performance during the past year, the MHRA also announced the launch of a new five-year strategy, which it will set out later this year.
The plan will detail 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.
On the safety front, the MHRA removed nearly 28 million unauthorised doses of medicine, tackled health misinformation and introduced strengthened post-market surveillance rules for medical devices.
Vigilance systems were also modernised as part of a broader programme to enhance safety monitoring capabilities.
The agency continued to advance its regulatory science agenda, with investment directed toward AI, in silico research and innovative methodologies.
Priorities included clinical trials reform, AI regulation and rare disease pathways — areas in which the MHRA has sought to build international leadership.
Partnership activity expanded both domestically and globally during the period. Notably, an aligned pathway developed jointly with the National Institute for Health and Care Excellence (NICE) aims to accelerate patient access to new treatments.
Internationally, the MHRA established a new UK-Singapore Innovation Corridor, joined the HealthAI network as an inaugural member and progressed collaboration with the US Food and Drug Administration (FDA) on medical device regulation as part of the wider US-UK pharmaceutical partnership.
Additionally, independent research cited in the report pointed to improved external sentiment among industry stakeholders, partners and system stakeholders during the past 12 to 18 months — a finding the MHRA attributed to sustained engagement efforts.
Health Minister Dr Zubir Ahmed said: "This past year has shown what a modern regulator looks like. The MHRA has made tangible progress on the 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.
Lawrence Tallon, MHRA Chief Executive, added: "We have a regulatory environment that's scientifically rigorous, agile and has patients at its heart."
With every performance target met, a strong financial position and more innovative medicines reaching patients, this is high-quality regulation in practice. It is a 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, concluded: "This progress is the result of the skill, professionalism and commitment of MHRA staff across science, regulation, digital, policy and services."
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.