Clinical trial applications increased by almost 10% in 2025, MHRA data show

Between January and November 2025, the Medicines and Healthcare products Regulatory Agency reported a 16% increase in trials involving healthy volunteers compared with the previous year.
A scientist examines a patient's blood during a clinical trial

Clinical trial applications in the UK rose by 9% between January and November 2025 compared with the same period in 2024, according to data from the Medicines and Healthcare products Regulatory Agency (MHRA).

On 13 January 2026, the MHRA said the figures showed that “the UK is ramping up efforts to become a global first choice for clinical trials”.

The data revealed a 16% increase in trials involving healthy volunteers, which the MHRA said was “often the first step in testing whether a new medicine is safe”.

According to the data, there was a 7% increase in trials being run in the UK for the first time. The MHRA added that this increase is a sign of rising international confidence in the UK as a place to start new research.

The data also show a 75% increase in the number of MHRA scientific advice meetings provided on clinical trials, which demonstrates that “companies are also coming to regulators earlier for help”, the MHRA said.

The NHS ten-year health plan, published in July 2025, set out plans for closer working between the MHRA and the National Institute for Health and Care Excellence and is intended to speed up access to medicines and health technology.

NHS England also pledged to speed up clinical trial recruitment. By March 2026, it said that set up time for clinical trials would be reduced to 150 days.

In its press release, the MHRA said that, under the new system, around one in five studies were expected to move on to a fast-track notification route. The agency also said it would introduce a 14-day assessment route for phase I trials.

“Alongside faster assessments, the new framework will support clearer, more agile routes to support innovation,” the MHRA said.

“This includes making better use of early safety data from overseas studies that meet UK standards, and new MHRA capability to assess computer model simulations, such as in-silico trials, to help predict how new medicines may behave before they are tested in patients.”

Commenting on the data, Janet Valentine, executive director of innovation and research policy at the Association of the British Pharmaceutical Industry (ABPI), said: “The rise in clinical trial applications reported by the MHRA is an encouraging sign and reinforces the growth in industry-led clinical trial initiations in the UK during 2024, as highlighted in the ABPI’s latest annual clinical trials report.

“Speed and predictability in regulatory approvals are critical to setting up clinical trials and will be essential to meeting the government’s ambition of a 150-day set-up. We therefore welcome the MHRA’s efforts to accelerate regulatory processes.

“These improvements must be sustained, so the UK can consistently deliver rapid trial set-up and timely patient recruitment.”

In December 2025, the ABPI warned that although the overall number of interventional research participants rose in 2024/2025, the number of people taking part in commercial interventional research studies had declined.

It also urged the government and the NHS to address this to “ensure the UK remains a competitive location for commercial clinical trials, which generate valuable income for the NHS, and allow UK patients to benefit from participating in cutting-edge medical research”.

Last updated
Citation
The Pharmaceutical Journal, PJ January 2026, Vol 316, No 8005;316(8005)::DOI:10.1211/PJ.2026.1.394114

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