Contributor:
Fajar Dumadi, BSc
ISCT
Canada
The Human Medicines Regulations 2012 (“HMR 2012”) have been amended to take account of the manufacture of a point of care (POC) medicinal product (this includes home-base manufacture) and modular manufactured (MM) medicinal product (this includes mobile manufacture) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 [SI 2025 No. 87], which come into force on 23 July 2025.
The need for new guidance arises from the differences between Decentralised Manufacture (DM) and conventional manufacturing operations, which will create some specific issues and challenges. Examples of these include:
- a relatively large number of manufacturing sites which may be geographically widely distributed within the UK with many in novel locations.
- a wide and diverse array of different manufacturing techniques some of which may not be used in conventional centralised manufacturing.
- a ‘hub and spoke’ structure, pivotal to the regulatory flexibilities of DM which relies upon a central Control Site at its hub to manage manufacturing activities between the individual manufacturing sites (the spokes).
- the challenges relating to assurance of consistent manufacture of products of comparable quality across potentially a large number of different sites.
- the likely co-location of manufacturing sites on or within the premises of other organisations such as healthcare providers.
- the need to develop products and process intended for DM, using enhanced process understanding where surrogate measures such as critical process parameters may be required for product release.
Webinars and further information
- Watch the video recording of the MHRA modular manufacture and point of care regulations webinar held on 28 January 2025 [access link]
- Watch the video recording of the Decentralised Manufacturing Regulations Update Webinar, which took place on 17 June 2025 [access link]
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