Last updated: 26 March 2025
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What is POC manufacturing?
POC manufacturing refers to the manufacture of personalised medicines made for the patient either within or very close to where they are receiving care, for example, an operating theatre, ambulance or a military hospital. Many POC products have a short shelf life. Some need to be used within minutes, so they cannot be manufactured in advance or supplied from a distance.
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.
Timeline leading to POC regulation
| 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 has now been made into law and will come into force on 23 July 2025. During this transition period, the MHRA are drafting guidance that it will share with partners in the coming weeks. 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. |
Source: MHRA
Decentralised manufacture hub
Statutory Instrument 2025 87 will introduce regulatory changes for the manufacture of medicines at – or close to – the point of patient care.
- Point of care (POC) and modular manufacture (MM) are collectively called decentralised manufacture (DM).
- DM processes allow medicinal products to be made at or close to a patient’s location for administration of the medicine.
- To enable 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. The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 will come into effect on 23 July 2025.
- DM presents some new challenges compared with traditional medicinal product manufacture.
- The MHRA is developing new regulatory guidance in the following areas to provide clarity on regulatory expectations and will add it to this collection when published:
- developing the following DM guidance
- clinical trial authorisation (CTA) and good clinical practice (GCP) guidance
- designation guidance
- DM master file template
- good manufacturing practice (GMP) guidance
- guidance to help interpret the new regulation
- labelling guidance
- marketing authorisation application (MAA) guidance
- pharmacovigilance (PV) MA guidance
- PV early access to medicines scheme (EAMS) guidance
- PV specials guidance
- Stakeholders were consulted on draft guidance at an in-person workshop in March 2025.
- The guidance will be published in early summer 2025.
- The new guidance will supplement existing guidance. You should use it in conjunction with those texts.
- Internationally, work has commenced to align regulatory expectations for DM, through the International Coalition of Medicines Regulatory Authorities (ICMRA). We will continue to work actively with the ICMRA and other international regulators.
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].
Source: MHRA