Manufacturing sites and a control site will work together in a hub-and-spoke model that has key differences from conventional manufacturing operations.
Pharmaceutical Optical Ampoule / Vial Inspection Machine. 3d illustration | Image Credit: © unlimit3d - stock.adobe.com
New regulations for decentralized manufacture, a term which encompasses both point-of-care and modular manufacture, are being put into effect by the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) as of July 23, 2025 (1). A statute signed into law in the UK six months prior, in January 2025, allowed for a six-month implementation period during which guidance documents in all affected areas of medicinal product regulation were created.
As defined by MHRA, point-of-care products refer to those that can only be manufactured at or near the location of use or administration, due to their method of manufacture, shelf life, or route of administration, among other factors (1). Modular manufacture refers to products for which it is expedient or necessary to be manufactured, or assembled, in a self-contained modular unit—with a particular emphasis, MHRA said, on faster deployment of pandemic vaccines.
The updated regulations classify the process by which decentralized manufacture products are made into a “hub-and-spoke” model, according to MHRA (1). In this configuration, manufacturing sites are the spokes, and a single control site is the hub, the latter being the only location named on the manufacturer’s license, tasked with managing overall manufacturing aspects.
MHRA said the need for new guidance grew in part out of the differences between decentralized manufacture and conventional manufacturing operations (1). The hub-and-spoke structure is one of these elements but so is the need to develop products and processes specifically intended for decentralized manufacture.
Also at issue are the potential wide geographic distribution of manufacturing sites in novel locations throughout the UK, the diverse array of manufacturing techniques that may not be used in conventional centralized manufacturing, co-location of manufacturing sites on the premises of other organizations like healthcare providers, or consistency of quality assurance.
Neil Smith, president of consumer packaged goods at France-based Schneider Electric, said in an email shared with Pharmaceutical Technology® Group that the legal framework set forth by MHRA is indicative of a new era of personalized healthcare.
“By enabling hospitals, clinics, and even ambulances to produce patient-specific treatments in real time, the UK is setting a precedent that could reshape how medicines are developed, delivered, and regulated globally. This leadership is likely to attract significant international investment in biotech and advanced manufacturing, reinforcing the UK’s position as a hub for innovation in life sciences,” Smith said (2). “The UK’s leadership in this space is not only a win for patients—it’s a blueprint for how industrial innovation can drive better outcomes, faster time to market, and more resilient supply chains.”
MHRA said that the decentralized manufacture concept, at least as the agency has planned to implement it, is still in an early stage and that the new sector will change considerably in the next several years (1). Internationally, work began on harmonization with an International Coalition of Medicines Regulatory Authorities workshop in December 2024, and future guidance documents are expected with, as Smith suggested, the new UK regulations serving as a potential model for changing global workflows in manufacturing.
1. MHRA. Decentralised Manufacture Hub. Gov.UK, updated July 2, 2025 (accessed July 22, 2025).
2. Comments from Neil Smith received via email correspondence, July 22, 2025.
Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.
