The UK Government has passed legislation to decentralise the manufacture of personalised medicines, allowing them to be prepared in facilities closer to the patient.
The recently passed 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 to be made at the point of care.
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Introduced by the Medicines and Healthcare products Regulatory Agency (MHRA), it will allow patients to receive personalised treatments made at their hospital, clinic or near their homes. Therapies are currently manufactured in laboratories, which extends the vein-to-vein timeframe due to shipping requirements.
The framework includes the manufacture of cell and gene therapies, tissue-engineered treatments, 3D-printed products, blood products, and medicinal gases.
This will reduce the amount of time for a patient to receive personalised therapies by potentially months, stated UK Health and Social Care Secretary Wes Streeting.
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.”
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By GlobalDataBy accelerating the manufacturing time of CAR-T therapies, it can reduce the instances in which patients become too unwell to receive the therapy. There are also times in which the medicine’s short shelf life meant that by the time it was delivered back to the patient, it could not be administered.
The legislation also supports the use of mobile manufacturing units, offering close-to-home treatment for patients too unwell to travel, or whose weakened immune systems mean hospital visits carry extra risk.
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.”
Decentralising manufacturing has previously been seen as an “up-and-coming development” in the cell and gene therapy sector due to high costs associated with setting up these processes.
The new legislation is part of the NHS 10-year plan, which was announced by Streeting and UK Prime Minister Keir Starmer on 5 July.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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