What is Decentralised Manufacturing (DM)?
DM brings a new manufacturing model to the pharmaceutical industry whereby a central site supervises and controls one or more ‘decentralised’ sites located close to patients. These sites can perform various manufacturing and testing functions via two distinct routes:
- Point of Care (POC): products that are made near the patients, and
Modular Manufacture (MM): products that are made in relocatable, self-contained units, designed for rapid deployment in the cases of exceptional public health needs. - This framework came into force on 23rd July 2025 when the amendments to the Human Medicines Regulations 2012 were implemented. Equivalent legislation in the EU is not yet currently in place, although similar proposals are being investigated.
Why has this been introduced?
This new set of regulations aims to move the tightly controlled manufacturing and testing steps from a single location (e.g. a factory) to be closer to the patient. Short-lived therapies and those highly personalised to an individual are set to benefit from this new model, as potential journey times for medicinal products to patients becomes shorter.
Key differences to the current model
As well as moving the physical location of certain manufacturing activities, DM has a broad impact to consider. For licences that utilise a DM designation in the UK:
- The Control Site is the only manufacturing site named on the Manufacturer’s / Importer’s Licence (MIA) and the site identified in CTA/MAA submissions. Individual POC/MM sites are not listed as manufacturing sites there as they are identified and controlled via the product-specific DM Master File (DMMF).
- The control site must demonstrate remote oversight of the other sites in inspections, including procedures, equipment, data integrity etc.
- There are cases where labelling requirements differ for POC products (i.e. pre-labelling of final containers if the product will be used immediately after manufacture is advised by the MHRA).
- A different release strategy is available for POC products.
- Immediate-use release at the local site can be used instead of relying on batch release and end-product testing prior to QP certification (real-time release testing is employed in its place). Note: MM products follow the ‘traditional’ release pathway.
How to obtain a DM designation
The first consideration when aiming to explore DM is whether your product is eligible for either POC or MM. Only certain products qualify, for example, if there is no regulatory need to pursue a designation and no patient benefit from it, you will be unable to proceed. POC can only be designated due to constraints relating to method of manufacture, shelf-life, its constituents or route of administration. MM is only used for products that may need deployment in special public health scenarios. Pleading a case for convenience alone will not justify a DM designation. Alongside this application, a DMMF and DM quality system should be developed.
For products where a DM designation makes sense, submit a MHRA DM designation application (before MAA for new products). The assessment typically takes 60 days, or 90 days if further information is required. Fees align to those for scientific advice, and there are no appeals if refused.
After a DM designation is granted, if applicable, apply for the (or modify the existing) Manufacturing Licence for the control site. All other DM sites will be included in the DMMF. You can then submit the MAA for new products or submit a Type II unforeseen variation for pre-existing licences.
If you would like to discuss how Fusion Pharma can support you with decentralised manufacturing, please email us at hello@fusion-pharma-limited.com or phone us on +44 (0) 203 1379 799.
While the information in this article is considered to be true and correct at the date of publication, changes in guidance and/or experience may impact on the accuracy of the information. Please refer to the relevant guidance for the latest information.
