UK Legislates for Point-of-Care Manufacture

Date
October 28, 2024
Category

UK Regulations

Description

The MHRA initiated a consultation on what they called “Point of Care (POC)” manufacturing in August 2021. This proposed a hub and spoke model based on a Control Site; that would be the primary focus of regulatory controls by MHRA. The Control Site would be a physical site that is named on the clinical trial or marketing authorisation application. The Control Site would be responsible for overseeing all aspects of the POC manufacturing system including the addition of new manufacturing sites and control of each manufacturing location and its activities.

On 25 January 2023 the UK government issued their response to the POC consultation. There was significant support for the creation of a new UK regulatory framework for manufacture and supply at the POC: 91% of responders agreed with the need for a new POC framework and 94% agreed with the proposed framework.

On 21 October 2024 a Statutory Instrument (SI) was laid in the UK Parliament to provide a new regulatory framework for point-of-care manufacturing, meaning that medicines with a very short shelf life and highly personalised medicines can more easily be made in or near a hospital setting.

Ian Rees, Point of Care lead at the MHRA, said: “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.”

The legislation proposes a six-month implementation period once Parliamentary processes have been concluded. This regulation could, therefore, become law in Summer 2025.

The EU has proposed the same model, which they call decentralised manufacture, in the revised human medicines Directive that was published in April 2023. This change to EU legislation is still being discussed and it is unlikely to be finalised until sometime in 2025, at the earliest, and will then probably have a 2 or 3 year implementation period.