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Point of Care Medicines Manufacture Regulations
22 October 2024
Type
Written Ministerial Statement
Department
Department of Health and Social Care
At a Glance
Issue Summary
This statement announces the drafting of regulations to support innovative manufacturing methods for medicines near patients.
Action Requested
The draft Human Medicines (Amendment) Regulations 2024 were laid before Parliament and will create a new regulatory framework for point-of-care and modular manufacturing, supporting pioneering medicines with high personalisation. This framework aims to enable patient access to advanced treatments while maintaining safety standards.
Key Facts
- The UK will be the first country to introduce this regulatory framework.
- Point of Care products include cell or gene therapies, 3D-printed medicines, and personalised blood-derived treatments.
- Current regulations are not suitable for multiple-site manufacturing across the country.
- The draft regulations follow a public consultation with 91% agreement on necessity and 94% support for the proposed framework.
- Regulations have been published on GOV.UK.
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