New legislation will mean that patients will be able to access personalised treatments made near their homes, in a world-first move from the Medicines and Healthcare products Regulatory Agency (MHRA).
This will mean that breakthrough personalised medicines can be prepared in small or individual batches and prepared at their hospital, clinic, or close to home, rather than waiting weeks for medicines to be manufactured hundreds of miles away.
Until now, personalised treatments such as CAR-T cancer therapy had to be sent to specialised manufacturing facilities often far away, causing long delays, sometimes meaning patients cannot access the therapy in time before their condition deteriorates. But from today (23rd July), hospitals, ambulances and local care settings in the UK have a pathway to carry out the final manufacturing steps for these personalised treatments on site, using clear, regulated protocols.
The legislation, The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025, makes the UK the first country in the world to introduce a dedicated legal framework for medicines made at the point of care.
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 pledged 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.”
MHRA chief executive Lawrence Tallon said: “Patients will not 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 can bring these new treatments to patients.”
