World-first legislation backs decentralised manufacturing

New regulation enforced by the Medicines and Healthcare products Regulatory Agency (MHRA), means the UK is the first country to introduce a legal framework enabling cutting-edge personalised medicines to be manufactured at point of care.

These therapies, such as CAR-T cancer therapy, have previously been produced in specialist facilities often far away from patients, resulting in treatment delays.

The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 reduces waiting times and boosts access to innovative therapies, MHRA explained. For example, cell and gene therapies and blood products can be returned to patients within days instead of months, and made at the bedside, “not hundreds of miles away,” UK Health and Social Care Secretary Wes Streeting stated.

This involves the final manufacturing steps for these therapies being conducted on-site, similar to how chemotherapies are prepared locally, but with the strict safeguarding protocols for more advanced therapies.

Streamlining a pathway for improved point of care treatment – MHRA’s approach

Earlier this year, the MHRA published detailed guidance to support implementation of the framework. The agency has also provided information for companies looking to apply for a decentralised manufacture designation.

From 23 July, this change “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,” Cell and Gene Therapy Catapult Chief Executive Matthew Durdy commented.

“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,” UK Science Minister Lord Vallance shared.