UK Legalises Hospital-Based Manufacture of Personalised Therapies

In a world-first move, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has passed legislation allowing personalised drug therapies to be manufactured directly at hospitals and mobile units, signalling a radical shift in treatment delivery.

The law covers technologies including CAR-T cell therapies and 3D-printed pharmaceuticals, many of which are tailored to a patient’s genetic or immunological profile.

Previously, production of these bespoke treatments could take months and required centralised facilities. The new legal framework enables on-site formulation, reducing waiting times to as little as 24–48 hours.

Under the MHRA’s updated oversight model, stringent safety and quality checks will be maintained, but manufacturers will benefit from simplified compliance pathways focused on agility and transparency.

Health leaders believe the change could be transformative for cancer patients, those with rare diseases, and anyone in urgent need of highly targeted treatments.

The policy also aligns with broader efforts to build decentralised health infrastructure, allowing innovations to reach bedside settings without the drag of traditional supply chain barriers.