Patients will receive faster access to life-saving, personalised treatments made at their hospital, clinic or near their homes instead of waiting weeks for therapies manufactured hundreds of miles away, under new UK legislation that comes into force today (23 July).<\/p>\n
This world first regulations, introduced by the Medicines and Healthcare products Regulatory Agency (MHRA), allows breakthrough personalised medicines to be prepared in small or individual batches \u2013 bringing care closer to the patient.<\/p>\n
A cancer patient could now have their immune cells collected, modified to fight their specific cancer, and returned within days rather than months. A child with a rare genetic disorder could receive a freshly prepared therapy with only minutes of shelf life, made and given on the spot.<\/p>\n
The change will cut waiting times where every hour counts, help free up NHS beds, and improve access to innovative therapies that were previously out of reach.<\/p>\n
Health and Social Care Secretary Wes Streeting said:<\/p>\n
\u201cThis 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.<\/p>\n
\u201cOur Plan for Change promised to build an NHS fit for the future. Today we\u2019re delivering on that pledge by bringing cutting-edge care directly to patients when they need it most.<\/p>\n
\u201cWe 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.\u201d<\/p>\n
Science Minister Lord Vallance said:<\/p>\n
\u201cThis world-first framework gives the NHS and innovators a clear, safe way to bring advanced treatments from the lab to the patient\u2019s bedside. It\u2019s a powerful example of how smart regulation can help more patients benefit from the best of British science.<\/p>\n
\u201cWe\u2019re 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 \u2013 with a view to unlocking growth, investment, and delivering a stronger, prevention-focused healthcare system.\u201d<\/p>\n
MHRA Chief Executive Lawrence Tallon said:<\/p>\n
\u201cPatients will now receive highly personalised treatments more quickly and nearer to their bedside, with the same rigorous standards as all medicines.<\/p>\n
\u201cThis is especially important where every hour matters, or where a treatment is so specific it simply can\u2019t be made in advance.<\/p>\n
\u201cIt\u2019s a landmark moment that opens the door to a future where highly personalised treatment \u2013 made for one person, in one place, at one time \u2013 becomes part of routine care.<\/p>\n
\u201cThe UK is leading the world in this next generation of medical innovation, and as the UK regulator for medicines and medical devices, we\u2019re determined to play our role in providing the supportive regulatory framework to help our health partners and medicines innovators bring can bring these new treatments to patients.\u201d<\/p>\n
From months to days<\/p>\n
Until now, personalised treatments such as CAR-T cancer therapy had to be sent to specialised manufacturing facilities often far away, causing long delays. In some cases, patients became too unwell to receive the therapy in time, or the medicine\u2019s short shelf life meant it couldn\u2019t be delivered at all.<\/p>\n
Hospitals were only able to offer these treatments through complicated, one-off arrangements, creating uncertainty for patients and doctors about whether treatment could go ahead.<\/p>\n
From today, hospitals, ambulances and local care settings in the UK have a pathway to carry out the final manufacturing steps for these personalised or time-sensitive treatments on-site, using clear, regulated protocols. This mirrors how chemotherapy or antibiotics are prepared locally, but with the same strict safeguards for more advanced therapies. A central control site will provide detailed instructions and oversight, while hospitals complete the process closer to the patient.<\/p>\n
Supporting care closer to home<\/p>\n
The legislation also supports the use of mobile manufacturing units \u2013 offering a safer alternative for patients too unwell to travel, or whose weakened immune systems mean hospital visits carry extra risk.<\/p>\n
This change enables care to be delivered where it\u2019s most appropriate, including community settings or even at home, supporting the NHS ambition, as set out in the 10 Year Health Plan for England<\/a>, to expand \u2018hospital at home\u2019 models such as virtual wards.<\/p>\n Backed by law \u2013 and leading the world<\/p>\n The legislation, known as 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.<\/p>\n Following strong support during the public consultation<\/a>, the framework covers a broad range of innovative products, including cell and gene therapies, tissue-engineered treatments, 3D printed products, blood products, and medicinal gases.<\/p>\n To support implementation, the MHRA published detailed guidance<\/a> earlier this year and has worked closely with other UK regulators, the NHS, industry, academics and healthcare professionals to ensure clarity around how the legislation applies in practice. Today, the MHRA has added information on how to apply for a decentralised manufacture designation. Companies can also access MHRA scientific advice at any stage of development.<\/p>\n The move strengthens the UK\u2019s leadership in safe, decentralised manufacturing and is expected to boost research, trials and patient access to cutting-edge treatments. The MHRA is also working internationally to support similar changes in other countries, recently being centrally involved in the first global workshop<\/a> on point-of-care manufacturing, through the International Coalition of Medicines Regulatory Authorities (ICMRA).<\/p>\n Cell and Gene Therapy Catapult Chief Executive Matthew Durdy said:<\/p>\n \u201cThis change demonstrates how the MHRA is leading in the UK\u2019s commitment to being at the forefront of modern healthcare, innovation and regulation. The MHRA has recognised that some practices are better with more flexibility, and that in a technology enabled world which allows better training, information and communication, flexibility can be enabled without compromising safety.<\/p>\n \u201cThis is not just a step forward for innovative medicines such as cell and gene therapies, it is a step towards enabling truly personalised medicine. We applaud this change introduced by the MHRA and look forward to a future where more patients can receive therapeutics tailored to their needs, quickly, cost-effectively and sustainably.\u201d<\/p>\n NHS England National Director for Specialised Commissioning John Stewart said:<\/p>\n \u201cThe NHS in England was the first health system in Europe to adopt personalised cancer medicines and has since built a strong track record as an early leader in the use of potentially curative gene therapies.<\/p>\n \u201cThe advanced treatments of today, will become the everyday healthcare of tomorrow, and forward-thinking regulatory changes like this will help enable the NHS to evolve patient care to deliver complex treatments to more people, in more places.\u201d\u00a0\u00a0<\/p>\n Notes to editors\u00a0<\/p>\n\n