Decentralised manufacture hub
Source: gov.uk (2025-09-15)

Information on the new regulations for decentralised manufacture, including point of care and modular manufacture, which come into effect 23 July 2025.

Introduction to the UK’s Guidelines on Decentralised Manufacturing

Point of Care (POC) and Modular Manufacture (MM) are collectively described as Decentralised Manufacture (DM). DM processes allow medicinal products to be made close to or at the location of the patient for administration of the medicine. DM medicines encompass a wide and diverse array of different manufacturing techniques which may not be utilised in conventional centralised manufacturing. These products typically include innovative products which are either:
- Point of Care (POC) – medicinal products that, for reasons relating to method of manufacture, shelf life, constituents or method or route of administration, can only be manufactured at or near the place where the product is to be used or administered.
- Modular manufacture (MM) – products that, for reasons related to their deployment, make it necessary or expedient to be manufactured or assembled in a self-contained modular unit. This may include products whose manufacturing schedule needs to be closely linked to patient conditioning prior to receiving the medicinal product, to enable faster deployment of pandemic vaccines.
All DM manufactured products will be based on a ‘hub and spoke’ manufacturing model with a Control Site at the hub and manufacturing sites at the spokes. The Control Site will be the only location named on the manufacturers licence and will manage overall aspects of manufacturing, including the generation and management of DM Master Files (DMMFs) (https://assets.publishing.service.gov.uk/media/688cd936dc6688ed5087838a/DM_Master_File_Template.docx), the individual manufacturing sites and their activities.

To support DM, the UK has amended the Human Medicines Regulations 2012 and the Medicines for Human Use (Clinical Trials) Regulations 2004 through Statutory Instrument 2025 87 (https://www.legislation.gov.uk/uksi/2025/87/contents/made).

This Statutory Instrument (SI) was signed into UK law on 23 January 2025 which initiated a 6-month implementation period to 23 July 2025. During this implementation period, guidance pages across all impacted areas of medicinal product regulation (#guidance) were created. The need for new guidance arises from the differences between 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.
The DM guidance texts supplement existing guidance documents and are therefore intended to be read and used in conjunction with these texts. For example, the GMP guidance are set out in the MHRA ‘Rules and Guidance for Pharmaceutical Manufacturers and Distributors’ (known as the Orange Guide), Eudralex Volume 4 (https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en) and PIC/S GMP (https://picscheme.org/en/publications?tri=gmp#zone).

Development of guidance texts involved a two-step process:
- Initial drafting of texts by MHRA for an in-person workshop on 12 March 2025.
- Finalisation of texts based on points raised during the workshop and from comments received following the workshop.
The workshop focused on two main areas:
- Technical: The texts are intended to cover all aspects of medicinal product regulations including GMP, GCP, clinical trials, GVP pharmacovigilance and Marketing Authorisations (MAs).
- Process: This principally focused on a Designation Step where MHRA will assess whether applications for a DM approach satisfies either the legal test for Point of Care or the legal test for Modular Manufacture as set out in SI 2025 87. Application for a DM designation is a critical step in the early engagement process with MHRA and which, when granted, provides clarity and certainty for the applicant to proceed to establish a DM system.
The finalised guidance texts are set out below in the section Guidance (#guidance).

Given the early stage of DM, it is expected that this new sector will change considerably over the next few years. As experience is gained, the guidance texts will be reviewed and revised.

From an international perspective, work has commenced through the International Coalition of Medicines Regulatory Authorities (ICMRA) with a workshop in early December 2024. A summary report (https://www.icmra.info/drupal/en/strategicinitiatives/innovation/dm_workshop_report_3dec2024) is available. In due course, it is expected that ICMRA and related international regulatory organisations will develop harmonised regulatory guidance documents and where this UK guidance will form an important contribution.

Exemplar products and processes

The new DM framework adds a new range of manufacturing and supply options which are illustrated in the flow diagram Spectrum of manufacturing (https://assets.publishing.service.gov.uk/media/6846f9434d039a010411f118/Spectrum_of_manufacturing.pdf). Examples could include (but are not limited to):

Modular
- Products where there is a high / critical need to align the manufacturing process to the preparation of patients for receipt of immunotherapy such as for the personalised treatment of cancer.
- Early stage delivery of pandemic vaccines where there is limited fill finish capacity and / or where there are problematic storage conditions and regional manufacturing is limited
Point of Care
- Point of Care – mobile: similar to MRI or CT scanners that are contracted by healthcare providers to provide manufacturing capability to meet intermittent or occasional clinical demand.
- Point of Care – healthcare establishment: Products that can only be manufactured and used during a surgical procedure or while the patient is being treated at an intervention on the ward.
- Point of Care – home: products that have been manufactured to an intermediate stage which are stable and held at the patient’s home in readiness for clinical authorisation to complete the manufacture using specialist manufacturing equipment.
Webinars and further information

Watch the video recording of the MHRA modular manufacture and point of care regulations webinar held on 28 January 2025:

video recording of the MHRA modular manufacture and point of care regulations webinar (https://www.youtube.com/watch?v=HhYGERVex8g)

Watch the video recording of the Decentralised Manufacturing Regulations Update Webinar, which took place on Tuesday 17 June 2025

Decentralised Manufacturing Regulations Update Webinar (https://www.youtube.com/watch?v=yXh7J9M5p6o)

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