The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has marked a major milestone with the release of its 2025-26 Annual Report and Accounts. A closer look at the agency's performance reveals a year of outstanding achievement, with significant benefits for patients, healthcare professionals, and the life sciences industry as a whole.
One notable highlight from the report is the approval of 921 medicinal products for use in the UK. Of these, an impressive 39 were entirely new medicines - a testament to the MHRA's ability to balance innovation with safety. Crucially, the agency consistently met its target timelines for assessing clinical trial applications and national medicine licence applications, demonstrating exceptional operational efficiency.
Regulatory authorities are also working tirelessly behind the scenes to combat illicit trade. The MHRA made significant strides in this area by removing a record 28.5 million doses of illegally traded medicines from circulation, with an estimated street value of £64.4 million. This included the closure of the UK's first known illegal factory producing unlicensed weight loss injections - a major success in safeguarding public health.
On the global stage, the MHRA has solidified its reputation as a leading regulatory authority by being designated a World Health Organization (WHO) Listed Authority. This prestigious recognition acknowledges the quality and robustness of the UK's regulatory system. The agency also played a key role in international collaboration through initiatives like the ACCESS consortium and contributed to shaping the future regulation of AI in healthcare, launching the National Commission into the Regulation of AI in Healthcare.
The MHRA has also made significant strides in its own regulatory framework, proposing a new Rare Disease Therapies Regulatory Framework and introducing the MHRA-NICE aligned pathway. This initiative aims to accelerate patient access to certain medicines by up to six months. Furthermore, the agency secured £7.5 million in new research grant funding to advance regulatory science and support innovation in medicines and medical devices.