World-first medicine manufacturing regulatory framework to be implemented

The UK is set to be the first country to introduce a new regulatory framework for innovative products manufactured at or close to the point of patient care, says the Medicines and Healthcare products Regulatory Agency (MHRA).

This Statutory Instrument means that patients can access highly personalised medicines and medicines with a very short shelf life more quickly. It will enable products such as cell or gene therapy that require manufacturing to be located close to the individual patient to be developed safely, the agency explained.

One key benefit is that innovative treatments can be manufactured in small, portable units near patients who cannot travel eg, due to the severity of their condition. Demand for delivery of care by hospitals will also be eased with implementation of the regulation.

It “will enable new and innovative ways of manufacturing medicines closer to the patients who need them while ensuring their quality, safety and efficacy,” Ian Rees, Point of Care lead at the MHRA stated.

Introduction of this framework was originally announced by the MHRA in January 2023. It follows a consultation with stakeholders in 2021, which resulted in great support for proposals for a framework focused on point of care and modular manufacturing.

Other benefits of the regulatory framework

As the first of its kind in the world, the framework will facilitate “increasing the attractiveness of the UK as a destination to market new life-saving medicines,” Rees continued.

MHRA shared that it will publish guidance to support implementation of the new regulations prior to the legislation coming into force. The agency anticipated that the regulation could become law in Summer 2025.