New UK clinical trials regulations have been signed into law, with a 12-month rollout starting 11 April. The reforms mark the most significant update in 20 years, aiming to enhance participant safety, expedite approvals, foster innovation and increase opportunities for people to engage in vital research.

Initially laid before Parliament in December 2024, the regulations focus on placing trial participants at the centre of clinical studies. Streamlined processes will support faster approvals and simplify testing of new treatments in the UK.

Lawrence Tallon, MHRA Chief Executive, said: “These new regulations are a key step towards a stronger, more responsive and risk-proportionate clinical trials system that works better for patients.”

The MHRA plans to implement flexible and proportionate regulation, enabling quicker patient access to potentially life-saving medicines while maintaining safety standards. New provisions like Combined Review and notification schemes will now be written into law.

Janet Messer, Director of Approvals Service at the HRA, noted: “These changes reflect our commitment to making it easier to do high-quality research that people can trust.”

The regulations were shaped by feedback from patients, researchers, doctors and industry. They aim to cut duplication, reduce bureaucracy for lower-risk trials and make the UK a destination for international trials.

Balversa (erdafitinib) has been recommended for use on the NHS as the first and only treatment in the UK for urothelial cancer (UC) involving a fibroblast growth factor receptor (FGFR3) alteration, which affects up to one in five patients with advanced disease.

The drug slows tumour growth, advancing time in treatment and improving quality of life.

Eligible patients will have unresectable or metastatic disease and will have previously received at least one line of therapy containing a programmed death receptor-1 or programmed death-ligand inhibitor.

Developed by global pharma company Johnson & Johnson, Balversa was recommended by the National Institute for Health and Care Excellence (NICE) based on the THOR study.

It found that Balversa increased overall survival from 7.8 months to 12.1 months compared to standard care chemotherapy in the second-line setting. It works by inhibiting or even stopping FGFR3-expressing cancer cell growth.

“We are delighted to have reached this outcome for people living with advanced urothelial cancer,” said John Fleming, UK Medical Director of Johnson & Johnson.
The treatment is highly accessible, taken once-a-day orally from the comfort of the patient's own home.

The approval has been celebrated by interim CEO of Fight Bladder Cancer, Melanie Costin, as a “transformative moment” and “significant step forward in care”.