Cutting-edge personalised treatments, made while you wait, will deliver specialised care to patients more quickly
Source: gov.uk (2025-07-22)

New regulations effective today will make it faster and easier for cutting-edge cancer treatments and personalised gene therapies to be made right where patients are treated.

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).

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 – bringing care closer to the patient.

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.

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.

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.”

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.”

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 can bring these new treatments to patients.”

From months to days

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’s short shelf life meant it couldn’t be delivered at all.

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.

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.

Supporting care closer to home

The legislation also supports the use of mobile manufacturing units – offering a safer alternative for patients too unwell to travel, or whose weakened immune systems mean hospital visits carry extra risk.

This change enables care to be delivered where it’s most appropriate, including community settings or even at home, supporting the NHS ambition, as set out in the 10 Year Health Plan for England (https://www.gov.uk/government/publications/10-year-health-plan-for-england-fit-for-the-future), to expand ‘hospital at home’ models such as virtual wards.

Backed by law – and leading the world

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.

Following strong support during the public consultation (https://www.gov.uk/government/consultations/point-of-care-consultation/outcome/government-response-to-consultation-on-proposals-to-support-the-regulation-of-medicines-manufactured-at-the-point-of-care), 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.

To support implementation, the MHRA published detailed guidance (https://www.gov.uk/government/publications/human-medicines-modular-manufacture-and-point-of-care-regulations-2025-overview/human-medicines-modular-manufacture-and-point-of-care-regulations-2025-overview) 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.

The move strengthens the UK’s 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 (https://www.icmra.info/drupal/en/strategicinitiatives/innovation/dm_workshop_report_3dec2024) on point-of-care manufacturing, through the International Coalition of Medicines Regulatory Authorities (ICMRA).

Cell and Gene Therapy Catapult Chief Executive Matthew Durdy said:

“This change demonstrates how the MHRA is leading in the UK’s 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.

“This 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.”

NHS England National Director for Specialised Commissioning John Stewart said:

“The 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.

“The 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.”

Notes to editors
- The regulations will take effect across the UK from 23 July 2025. For more information, visit The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (https://www.legislation.gov.uk/uksi/2025/87/introduction/made)
- Supporting guidance and updates can be accessed at Decentralised manufacture hub - GOV.UK (https://www.gov.uk/government/collections/decentralised-manufacture-hub)
- Products manufactured at the point of care are eligible for support through the MHRA ILAP (https://www.gov.uk/government/publications/innovative-licensing-and-access-pathway-ilap) pathway, which is in place to accelerate time to market and facilitate patient access.
- Government response to consultation on proposals to support the regulation of medicines manufactured at the Point of Care - GOV.UK (https://www.gov.uk/government/consultations/point-of-care-consultation/outcome/government-response-to-consultation-on-proposals-to-support-the-regulation-of-medicines-manufactured-at-the-point-of-care)
- The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health and Social Care.
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