The Medicines and Healthcare products Regulatory Agency (MHRA) has met or exceeded all statutory performance targets, according to its latest Results and Forecast report, reinforcing its position as one of the world’s leading medicines and medical devices regulators.
The report highlights progress in speeding up access to medicines and devices for UK patients, improving regulatory efficiency, and supporting innovation across the UK’s £100 billion life sciences sector.
During the 2025/26 financial year, the MHRA strengthened patient and public safety while accelerating access to new treatments.
This included tackling health misinformation, introducing stronger post‑market surveillance for medical devices, removing almost 28 million doses of unauthorised medicines, and modernising safety monitoring through enhanced vigilance systems.
At the same time, the agency delivered excellent on‑time performance across licensing, clinical trials approvals and safety decisions – meeting all statutory commitments and key performance indicators.
The MHRA closed the year in a financial surplus, reflecting improved operational stability and disciplined delivery.
The report also notes a rise in staff morale, with record participation in the staff survey and a marked improvement in the Engagement Score. Leaders said this reflects a more motivated, skilled and confident workforce.
Independent research also shows a sustained improvement in external sentiment, with more positive perceptions among industry partners, international regulators and wider system stakeholders over the past 12–18 months.
The MHRA continues to lead internationally in regulatory science, investing in areas such as artificial intelligence, in‑silico research, and new methodological approaches to evidence generation.
The agency has advanced pioneering work in:
- Clinical trials reform
- AI regulation
- Therapeutics pathways for rare diseases
These efforts aim to ensure regulation keeps pace with scientific progress while maintaining high standards of safety and effectiveness.
The report highlights significant expansion of collaboration, both nationally and internationally.
Key developments include closer alignment with NICE to accelerate patient access to medicines, the launch of a 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 UK–US pharmaceutical partnership.
These partnerships are designed to reduce duplication, improve consistency and make the UK an attractive destination for research and investment.
Building on this performance, the MHRA will publish a new five‑year strategy later this year.
The strategy will set out how UK regulation will evolve through to 2030, supporting:
- Patient safety and NHS priorities
- Scientific and technological innovation
- Economic growth across the life sciences sector
Dr Zubir Ahmed, Health Minister, 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.”
By combining strong safety systems with efficient, forward‑looking regulation, the agency aims to ensure UK patients benefit earlier from new medicines and devices, while supporting a competitive and globally connected life sciences ecosystem.
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