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Joint statement from the UK Space Agency, MHRA, the Regulatory Innovation Office and the Civil Aviation Authority

5th March 2026

Summary:
The statement explains how the four organisations will work together to create a supportive regulatory environment for companies exploring in-orbit manufacturing of pharmaceuticals. Microgravity conditions in space may allow medicines, particularly biologics and protein-based drugs, to be produced with improved purity, stability and crystallisation, which could enhance drug formulation and delivery.

The UK Space Agency is funding feasibility studies, including a project with start-up BioOrbit, to explore scalable systems for manufacturing medicines in orbit and to clarify the regulatory pathway for such products. Existing medicines regulations and the UK’s spaceflight licensing framework will continue to apply, while additional guidance, regulatory sandboxes and case studies are being developed to help innovators understand how these rules apply to space-based manufacturing.

The collaboration also includes engagement with the pharmaceutical supply chain, investment in research infrastructure and support for new technologies. Together these initiatives aim to encourage investment, enable innovation and ensure that medicines produced in space meet the same standards of safety, quality and regulatory oversight as those manufactured on Earth.

Link:
https://www.gov.uk/government/news/joint-statement-from-the-uk-space-agency-the-medicines-and-healthcare-products-regulatory-agency-the-regulatory-innovation-office-and-the-civil-avia

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