MHRA’s framework point-of-care personalized medicine goes into effect

The UK Medicines and Healthcare products Regulatory Agency's (MHRA) new framework, which allows certain personalized breakthrough medicines to be administered at the point of care to patients, went into effect on Wednesday. The agency said the regulation is the first of its kind and will significantly speed up the availability of treatments such as cell and gene therapy (CGT) products.

"Patients will receive faster access to life-saving, personalized 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," said MHRA. "This world first regulations, introduced by the Medicines and Healthcare products Regulatory Agency (MHRA), allows breakthrough personalized medicines to be prepared in small or individual batches – bringing care closer to the patient.

"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," the agency added.

MHRA noted that personalized medicines such as CAR-T cancer therapies tend to be delayed because they are produced at specialized manufacturing facilities, and as a result, patients often are not able to get the therapies in time. Furthermore, the agency said that when they were able to benefit from CAR-T therapies, hospitals were able to provide them through complicated and one-off arrangements that created a significant amount of uncertainty for patients and their physicians.

"From today, hospitals, ambulances and local care settings in the UK have a pathway to carry out the final manufacturing steps for these personalized or time-sensitive treatments on-site, using clear, regulated protocols," said MHRA. "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," the agency added.

In June, MHRA published six guidelines to support a new regulatory framework for decentralized manufacturing (DM) that detailed point of care and modular manufacturing in six areas. In particular, they addressed applying for DM designation, the procedure for obtaining marketing authorization for the DM, the clinical trial authorization (CTA) for DM, good pharmacovigilance practices, the application of good manufacturing practices (GMP) for DM, and labeling requirements. (RELATED: MHRA releases spate of new guidelines on decentralized manufacturing, Regulatory Focus 10 June 2025)

MHRA CEO Lawrence Tallon touted the new framework as one that will get treatments to patients faster and closer to where they are without compromising regulatory standards. He said it is especially important in situations when treatments need to be catered to patients and cannot be made in advance.

“It’s a landmark moment that opens the door to a future where highly personalized treatment – made for one person, in one place, at one time – becomes part of routine care," said Tallon. “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.”

MHRA

MHRA’s framework point-of-care personalized medicine goes into effect

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