The Medicines and Healthcare products Regulatory Agency (MHRA) has set out the next phase of its reforms for 2026.

The reforms are aimed at helping patients to access new treatments more quickly and boost the UK's competitiveness for global clinical research.

Newly released figures show an increase in activity in 2025, with the number of clinical trial applications received rising by 9 per cent between January and November 2025 compared with the same period in 2024.

The increase was most noticeable in early and innovative research.

Clinical trials involving healthy volunteers increased by 16 per cent, alongside rises in trials testing treatments in people for the first time (5 per cent), and those being run in the UK for the first time (7 per cent).

A package of changes will be delivered with new clinical trial regulations which are due to take effect from April.

Under the new rules, around one in five studies are expected to move onto a fast-track notification route, which will allow lower-risk trials to start sooner, while maintaining high safety standards and freeing up experts to focus on complex and early-phase studies.

A 14-day assessment route will also be introduced for phase 1 trials.

Health Innovation Minister Dr Zubir Ahmed said: "As a practising surgeon, I know just how crucial it is to harness medical breakthroughs, so patients get the latest and most advanced treatments quickly and safely. This Government is laser-focused on accelerating clinical trial set-up times and cementing our position as global leaders.

"These improvements mean we are making it even easier for companies to bring clinical trials to the UK, offering a single point of support, faster processes, and a more predictable pathway to launch studies.

"Our Plan for Change is working to drive global investment into life sciences and our economy, improve health outcomes and accelerate the development of medicines and therapies of the future."

MHRA Chief Executive Lawrence Tallon said: "Clinical trial sponsors are clear about what they need: speed, clarity and flexibility. We’ve made practical improvements that are helping trials move through the system more smoothly. The biggest shift is still to come. New rules will make it simpler to start lower-risk studies, strengthen support for early-stage research and embrace modern approaches, including adaptive trial designs and computer model simulations, while maintaining patient safety.

"Together, these reforms will help high-quality trials start sooner, giving patients earlier access to new medicines and making the UK a more competitive place to develop them.”