Personalised treatments to deliver specialised care to patients more quickly

Hospitals in the UK can now make personalised cancer treatments and gene therapies on site, potentially cutting delays from weeks or months to just days.

The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025, which came into force today (23 July), make the UK the first country with a dedicated legal framework for medicines produced at the point of care.

The new rules, introduced by the Medicines and Healthcare products Regulatory Agency (MHRA), allow hospitals, ambulances and local care settings to carry out the final stages of manufacturing personalised or time-sensitive treatments using regulated protocols.

Health and social care secretary Wes Streeting said: “This world-first legislation is a game-changer for patients. Cancer treatments tailored in days, not months. Life-saving therapies made at your bedside, not hundreds of miles away.

“Our Plan for Change promised to build an NHS fit for the future. Today we’re delivering on that pledge by bringing cutting-edge care directly to patients when they need it most.

“We are turning around our NHS with waiting lists at their lowest for two years – this type of therapy means patients can be treated and return home more quickly.”

Until now, therapies such as CAR-T — which involves modifying a patient’s immune cells to fight their specific cancer — were sent to specialist facilities, often located far away.

Delays meant some patients became too ill to receive the therapy, or medicines with short shelf lives could not be delivered in time.

Under the new framework, a cancer patient could have their cells collected, altered and returned for treatment within days.

A child with a rare genetic disorder could receive freshly prepared therapy made and administered on site, even if it has only minutes of shelf life.

The new legislation applies to cell and gene therapies, tissue-engineered treatments, 3D printed products, blood products and medicinal gases.

Hospitals will follow protocols with oversight from a central control site, similar to how chemotherapy or antibiotics are prepared locally.

Science minister Lord Vallance said: “This world-first framework gives the NHS and innovators a clear, safe way to bring advanced treatments from the lab to the patient’s bedside. It’s a powerful example of how smart regulation can help more patients benefit from the best of British science.

“We’re determined to clear the path for more health innovation of this sort.

“Our recently-published Life Sciences Sector Plan sets out our clear vision to do just that – with a view to unlocking growth, investment, and delivering a stronger, prevention-focused healthcare system.”

The regulations also support mobile manufacturing units, offering options for patients too unwell to travel or whose immune systems make hospital visits riskier.

The change supports NHS plans to expand ‘hospital at home’ care, including virtual wards.

MHRA chief executive Lawrence Tallon said: “Patients will now receive highly personalised treatments more quickly and nearer to their bedside, with the same rigorous standards as all medicines.

“This is especially important where every hour matters, or where a treatment is so specific it simply can’t be made in advance.

“It’s a landmark moment that opens the door to a future where highly personalised treatment – made for one person, in one place, at one time – becomes part of routine care.

“The UK is leading the world in this next generation of medical innovation, and as the UK regulator for medicines and medical devices, we’re determined to play our role in providing the supportive regulatory framework to help our health partners and medicines innovators bring these new treatments to patients.”