MHRA annual report shows stronger regulatory output and global reach

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MHRA annual report highlights

Highlights

MHRA approved 921 medicinal products in 2025-26, including 39 new medicines, meeting all target timelines and securing £7.5 million in new research grant funding.
Enforcement actions included removing a record 28.5 million illegal medicine doses worth £64.4 million and shutting the UK's first illicit unlicensed weight loss injection factory.
MHRA launched the National Commission into the Regulation of AI in Healthcare, achieved World Health Organization Listed Authority status, and previewed new trial regulations and pathways to expedite medicine access by up to six months.

Annual report outlines regulatory delivery

As reported by GOV.UK, the Medicines and Healthcare products Regulatory Agency has published its 2025-26 Annual Report and Accounts and is laying it before Parliament, setting out what it describes as a year of consistently high performance for patients, the public and industry.

The agency says it approved 921 medicinal products for use during the year, including 39 new medicines, and assessed all clinical trial applications and national medicines licence applications within target timelines. It also says it secured £7.5 million in new research grant funding to advance regulatory science and support innovation in medicines and medical devices.

Lawrence Tallon, MHRA chief executive, says the report shows the regulator is delivering faster and more consistently while supporting the NHS, clinical research and innovators. The agency also says its Clinical Practice Research Datalink continues to support public health research and regulatory decision-making through anonymised UK primary care data, while more than 154,000 biological reference materials were supplied globally.

UK life sciences and international impact

The report links the agency’s work to the UK life sciences sector, highlighting enforcement action and new policy development alongside product approvals. The MHRA says it removed a record 28.5 million doses of illegally traded medicines from circulation, with an estimated street value of £64.4 million, including the shutdown of what it calls the UK’s first known illegal factory producing unlicensed weight loss injections.

The regulator also says it is taking a leading role in AI oversight in healthcare through the launch of the National Commission into the Regulation of AI in Healthcare, which brings together global AI leaders, clinicians and regulators to advise on a new framework. During the year, the MHRA was designated a World Health Organization Listed Authority and continued work through international regulatory collaborations including the ACCESS consortium.

Looking ahead to 2026-27, the agency says it will implement new Clinical Trials Regulations, including a 14-day first assessment for phase 1 clinical trials, and publish its MHRA2030 Strategy. It also says a proposed Rare Disease Therapies Regulatory Framework and a jointly launched MHRA-NICE aligned regulatory pathway are intended to speed access to some medicines by up to six months.

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