Decentralised manufacture hub
Information on the new regulations for decentralised manufacture, including point of care and modular manufacture, which come into effect on 23 July 2025.
Introducing the new regulation
This information is to help you understand and prepare for the main regulatory changes that the Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 will introduce 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 new regulation will come into effect on 23 July 2025.
DM presents some new challenges compared with traditional medicinal product manufacture. We are developing new regulatory guidance to provide clarity on regulatory expectations. We consulted stakeholders on draft guidance at an in-person workshop in March 2025. We will publish the guidance in early summer 2025.
The new guidance will supplement existing guidance. You should use it in conjunction with those texts.
As DM is in its early stages of development, we will review and update the guidance regularly.
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.
Guidance
We are developing the following DM guidance and will add it to this collection when published:
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clinical trial authorisation (CTA) and good clinical practice (GCP) guidance
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designation guidance
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DM master file template
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good manufacturing practice (GMP) guidance
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guidance to help interpret the new regulation
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labelling guidance
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marketing authorisation application (MAA) guidance
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pharmacovigilance (PV) MA guidance
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PV early access to medicines scheme (EAMS) guidance
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PV specials guidance
We will also develop joint guidance with other regulators such as the Human Tissue Authority, where necessary.
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
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