In a move that will make it easier for NHS patients to access treatment, the UK Government is set to introduce a novel framework to benefit point of care manufacturing, the Medicines and Healthcare products Regulatory Agency has announced.
A statutory instrument was laid in parliament yesterday which will pave the way for a new framework that will see medicines with short shelf lives or highly personalised treatments more conveniently developed in or near hospital settings. The first-of-its-kind framework will also enable the manufacturing of medicines in small, portable units than can be set up in the vicinity of patients who may be too sick to travel.
Treatment transformation
The move is expected to especially help the development of personalised products like cell or gene therapies. The upcoming law change will also alleviate pressure on hospitals and give patients more appropriate care, further into the community – a government priority.
“Enabling patients to safely access innovative treatments and medicines is a top priority for the MHRA, which is why we have developed this novel regulatory framework,” said Ian Rees, point of care lead at the MHRA.
“This will enable new and innovative ways of manufacturing medicines closer to the patients who need them whilst ensuring their quality, safety and efficacy, with the consequent benefits both to patients and the healthcare system.”
Summer 2025
The news follows an initial consultation with stakeholders three years ago, which gathered widespread support for the proposals for a point of care and modular manufacturing regulatory framework. Once the parliamentary process has concluded, a six-month implementation period is expected for the regulation, meaning it could become law next summer.
Policymakers believe the move will make the UK a more attractive place to market new medicines. The MHRA is in the process of developing supporting guidance to ensure the implementation of the regulations is as smooth as possible.
Rees added: “This totally new framework, the first of its kind in the world, supports the MHRA’s drive to deliver for patients; making it possible to safely manufacture breakthrough medicines closer to where care is delivered and increasing the attractiveness of the UK as a destination to market new life-saving medicines.”
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