MHRA touts uptick in approvals in 2025-2026 annual report
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) touted its achievements over the last year its 2025-2026 annual report to Parliament, which includes approving more new drugs than the prior year, removing a record number of illegal drugs from circulation, and taking steps to advance the regulation of artificial intelligence (AI) in healthcare.
In the report, published last week, MHRA said it met and exceeded goals laid out in its 2025 Results and Forecast report.
"This year’s Annual Report shows the MHRA delivering faster, more consistently and with even greater impact for patients, the [National Health Service (NHS)] and innovators," said MHRA CEO Lawrence Tallon. "From approving new medicines and supporting clinical research to disrupting criminal supply chains, our focus remains on protecting public health while embracing innovation."
Some of the key achievements outlined in the report include approving 921 drugs for the UK market, 62 more than in the previous year. Of those, 39 of the approvals were for new drugs. MHRA said it did so while assessing all clinical trial applications and national medicines license applications within their targeted timelines.
MHRA also touted that it had removed a record 28.5 million doses of illegal drugs with an estimated street value of $86.5 million, including the country's first known counterfeit weight loss drug manufacturing facility in October 2025 in Northampton.
"During the two-day operation, officers seized thousands of finished products and more than 2,000 unlicensed weight loss injection pens containing substances such as tirzepatide and retatrutide, alongside tens of thousands of empty pens ready for filling," said MHRA. "Further coordinated enforcement activity in February 2026, involving MHRA, police, Immigration Enforcement and Trading Standards, targeted additional premises linked to the same organised criminal network.
"These actions resulted in the seizure of further unauthorised medicines, manufacturing equipment, packaging materials and vehicles used to facilitate distribution," the agency added.
MHRA also said that it played a leading role in shaping the future of AI in healthcare. Its efforts include bringing together global AI experts in the National Commission into the Regulation of AI in Healthcare to advise it on developing a new AI regulatory framework. It also touted its efforts to advance AI adoption through its AI Airlock project, which serves as a regulatory sandbox to test emerging technologies in a controlled environment, and its work partnering with global regulators on the issue.
Other achievements by MHRA in the report include proposing a new Rare Disease Therapies Regulatory Framework, and launching a joint regulatory pathway with its health technology assessment agency, the National Institute for Health and Care Excellence (NICE), called MHRA-NICE to speed patient access to new treatments, sometimes as quickly as six months. It also said it secured $10M in new research grants for regulatory science and innovation, advanced research through its Clinical Practice Research Datalink (CPRD) to generate real-world evidence and supplied more than 154,000 biological reference materials globally.
"The annual report, which is being laid before Parliament, demonstrates how the MHRA has maintained a consistently high level of performance throughout the year, delivering for patients, the public and industry while building a strong foundation for future innovation and growth," said MHRA. "It highlights the breadth of the agency’s impact in protecting public health and supporting the UK’s life sciences sector, including authorising hundreds of medicines, removing a record number of illegally traded products from circulation, and pioneering new approaches to AI regulation."
Tallon noted that when he was appointed MHRA CEO last year, his priority was to restore performance at the agency and create the conditions for it to grow. Having achieved that goal, he said the past year has been spent shifting to maintaining that performance and advancing its capabilities to be a proportionate and agile regulator.
"This is central to strengthening the UK’s life sciences ecosystem and contributing to economic growth," said Tallon. "This includes delivery through the AI Airlock, development of regulatory approaches for rare diseases, progress on medical devices reform, and strengthened international collaboration through our leadership of the ACCESS consortium.
"Our work with NICE and system partners is helping to create clearer, more aligned pathways that support earlier patient access to innovation," he added.
Having published the annual performance report, MHRA said it will next publish its MHRA2030 Strategy, which will outline how it plans to sustain performance, ensure patient safety, support innovation, and modernize the agency.
