The UK will be the first in the world to introduce a framework for the regulation of innovative products manufactured at, or close to the location where a patient receives care, says the Medicines and Healthcare products Regulatory Agency (MHRA).
A recent statutory instrument placed in the UK Parliament provides this new regulatory framework — allowing medicines with a short shelf-life and those that are highly personalised to be made in or near a hospital setting to reach patients safely and quickly.
The regulation will also allow for the manufacture of innovative medicines in small, portable units that can be set up close to patients who may be too sick to travel, or whose reduced immunity precludes travel, or where rapid medicine availability is best served.
This novel UK regulatory framework will transform patient treatment by enabling the safe development of innovative, personalised products such as cell or gene therapy that need to be manufactured close to the individual patient.
It will help relieve pressure on hospitals by enabling delivery of care where it is most appropriate for the patient, in community settings or their homes, supporting the ambition to expand ‘hospital at home’ services.
Ian Rees, MHRA Point of Care lead, says the move would enable new and innovative ways of manufacturing medicines closer to patients, ensuring quality, safety and efficacy, besides benefiting patients and the healthcare system.
This is the first of its kind in the world, he says, 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.
The legislation proposes a six-month implementation period once parliamentary processes conclude. It could become law in Summer 2025.
(Source: MHRA)