Last updated: 2 July 2025
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What is 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.
Which product types are included as POC products?
POC products include some types of Advanced Therapy Medicinal Products, for example cell therapy, gene therapy and tissue engineered products; 3D printed products, which might include patient specific prosthetics; blood products and medicinal gasses.
The ‘hub and spoke’ manufacturing model on which All DM manufactured products will be based
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),
- the individual manufacturing sites and their activities.
Timeline leading to The Modular Manufacture and Point of Care regulations 2025
| Date | Event |
|---|---|
| Aug -Sept 2021 | Consultation seeking views on innovative medicines manufacture at point of care |
| 25 Jan 2023 | Consultation on Point of Care manufacturing – Consultation outcome |
| 21 Oct 2024 | Statutory Instrument laid in Parliament provides first regulatory framework of its kind that will transform the manufacture of innovative medicines at the point of patient care It means that medicines with a very short shelf life and highly personalised medicines can more easily be made in or near a hospital setting and can get to the patients who need them safely and much more quickly. The regulation will also allow for manufacture of innovative medicines in small, portable units that can be set up close to patients who may be too sick to travel or whose reduced immunity precludes travel or where rapid medicine availability is best served. |
| 23 January 2025 | The The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 This Statutory Instrument (SI) was signed into UK law on 23 January 2025 which initiated a 6-month implementation period to 23 July 2025 (the date when it comes into force). During this transition period, the MHRA are drafting guidance that it will share with partners as soon as it becomes available. This new framework is the first of its kind in the world and supports the MHRA’s drive to deliver for patients; making it possible to safely manufacture breakthrough medicines closer to where care is delivered. It will also increase the attractiveness of the UK as a destination to market new life-saving medicines. |
The amendment of the Human Medicines Regulations to support Decentralised Manufacturing
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.
- This Statutory Instrument (SI) was signed into UK law on 23 January 2025 which initiated a 6-month implementation period to 23 July 2025. Here is a link to the Human medicines Modular Manufacture and Point of Care regulations 2025: Overview
- During this implementation period, guidance pages across all impacted areas of medicinal product regulation were created.
UK Guidelines on Decentralised Manufacturing
Below are links to the guidances available to date.
| Guidance | About the guidance |
|---|---|
| Decentralised manufacture: The designation step | MHRA’s mechanism for evaluating the justifications supplied by applicant organisations who plan to utilise decentralised manufacture. |
| Decentralised Manufacture: Marketing Authorisation application | Guidance on applying for a Marketing Authorisation for Decentralised Manufacture, including eligibility, process, and requirements. |
| Decentralised manufacture: Clinical Trial Authorisation (CTA) and Good Clinical Practice (GCP | Guidance for clinical trials that use Decentralised Manufactured Investigational Medicinal Products (IMPs). |
| Decentralised Manufacture: UK Guideline of Good Pharmacovigilance Practices | Guidance covering various aspects of pharmacovigilance for authorised and unauthorised medicinal products (Specials and the Early Access to Medicines Scheme (EAMS). |
| Decentralised manufacture: UK Guideline on Good Manufacturing Practice (GMP) | UK guideline on GMP for decentralised manufacturing, ensuring compliance with EU GMP principles for safe, quality medicinal products. |
| Decentralised Manufacture: Labelling | Guidance on labelling requirements pertinent to the type of medicinal product and its supply status, as defined in UK legislation. |
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 but are not limited to:
- 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 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 and PIC/S GMP.
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.
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. 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.
MHRA Modular Manufacture and Point of Care Regulations Webinars
1) You can watch the video recording of the MHRA modular manufacture and point of care regulations webinar held on 28 January 2025, here.
A summary of the YouTube video clip as provided by the chatbot Google Gemini is provided below:
This webinar, hosted by the MHRA [00:07], discusses the regulations surrounding decentralized manufacturing, which includes modular manufacturing and point of care.
Here’s a breakdown:
- Background and Objectives: The MHRA aims to update on progress, share information, and outline next steps regarding decentralized manufacturing regulations [01:14].
- Decentralized Manufacturing: This approach complements traditional centralized manufacturing, ensuring equivalent levels of quality, safety, and efficacy [08:13]. It encompasses various methods, including modular, mobile, point-of-care, and even home-based manufacturing [19:09].
- Legal Tests: To avoid confusion, legal tests have been introduced. Point of care manufacturing is restricted to situations where products must be made at or near the point of use [25:14]. Modular manufacturing applies when deployment-related reasons necessitate it [26:17].
- Key Components: The framework relies on a “hub and spoke” model, with a central control site overseeing manufacturing at local sites [21:31]. A master file captures product, process, and procedural aspects [22:12].
- GMP Considerations: Manufacturing sites require a license that includes point of care or modular manufacturing operations, along with an approved master file [44:38].
- Pharmacovigilance: Existing regulations apply, with specific considerations for decentralized manufacturing, including adverse event collection, signal detection, and the pharmacovigilance system master file [45:45].
- GCP: The decentralized method of manufacture doesn’t fundamentally change how a clinical trial is run, but it’s important to be clear about how it’s going to function within that clinical trial [52:35].
- Quality Dossier: The general quality dossier requirements for decentralized manufactured products remains aligned with the common technical document [54:58].
- Next Steps: The MHRA is developing technical and process guidance, with a workshop planned for March 12th [56:55]. They aim to publish guidelines before the regulations take effect in July [57:07].
- International Collaboration: The MHRA is working with international regulators to align approaches [33:11].
2) You can watch the video recording of the MHRA modular manufacture and point of care regulations webinar held on 17 June 2025, here.
A summary of the YouTube video clip as provided by the chatbot Google Gemini is provided below:
This webinar provides an update on decentralized manufacturing regulations.
Here’s a breakdown of the key topics:
- Introduction to Decentralized Manufacturing [05:07]: The MHRA (Medicines and Healthcare products Regulatory Agency) has been working for about 10 years to develop a framework for decentralized manufacturing, which includes “point of care” and “modular” manufacturing. This aims to broaden manufacturing and supply options while maintaining quality, safety, and efficacy standards.
- Types of Decentralized Manufacturing [11:49]:
- Modular Manufacturing: Involves relocatable units that can be moved between factories or to locations near hospitals, potentially for early-stage pandemic vaccine production or cancer immunotherapies.
- Point of Care Manufacturing: Products are manufactured at or very close to where the patient is located, such as intraoperatively (during surgery), on the ward, or even in a patient’s home. This is particularly relevant for products with very short shelf lives.
- Hub and Spoke Model [16:32]: The framework operates on a hub and spoke model, where a central “control site” is responsible for managing all manufacturing sites (spokes). The control site generates a Decentralized Manufacturing Master File (DMMF) [16:56], which details how new sites are onboarded, decommissioned, and controlled to ensure consistent manufacturing.
- Legislation and Implementation [21:56]: The relevant legislation (Statutory Instrument 202587) was signed into UK law on January 23rd and comes into effect on July 23rd. The MHRA has created a “collection hub” website [01:11:02] as a one-stop shop for all related information, including legislation, guidance documents, and case studies.
- Designation Step [33:18]: A rapid designation process has been formalized to provide assurance that a proposed product meets the decentralized manufacturing criteria. This involves an application with justification, and the MHRA aims to provide a decision within 60-90 days.
- GMP Aspects [39:42]: Manufacturing license holders will need to apply to add decentralized manufacturing to their site licenses. The control site will be inspected to ensure proper oversight of all spoke sites, including consistent release activities, staff training, and equipment use.
- Pharmacovigilance Considerations [50:04]: Specific pharmacovigilance considerations are required due to potential manufacturing variability and the number of sites. Key aspects include:
- Risk Management Systems: Risk management plans (RMPs) will need to discuss the healthcare setting and include activities to support traceability of adverse drug reactions to specific product batches and manufacturing sites.
- Adverse Event Reporting: Batch numbers or other product identifiers must be reported with adverse reactions.
- Safety Data Evaluation: Periodic Safety Update Reports (PSURs) will require exposure data stratified by manufacturing site, and signal detection needs to be frequent enough to identify serious safety concerns at the manufacturing site level.
- Quality Management System: Provisions must be in place to collect safety information and ensure its flow from the manufacturing site to the control site and safety department.
- CTA and MAA Submissions [01:01:32]: Quality dossier requirements for Clinical Trial Authorization (CTA) and Marketing Authorization Application (MAA) submissions remain aligned with common technical document requirements, but additional development information may be needed commensurate with the risks of decentralized manufacturing.
Source: MHRA