The UK is taking steps to support the development and manufacture of innovative medicines in microgravity. Through collaborative work between the Medicines and Healthcare products Regulatory Agency (MHRA) and the UK Space Agency, the UK has published the first dedicated regulatory pathway for space-manufactured medicines and issued a joint statement from the UK Space Agency, MHRA, Regulatory Innovation Office and Civil Aviation Authority setting out a coordinated approach to in-orbit pharmaceutical manufacturing.
Drawing on deep expertise in pioneering new regulatory approaches, including the introduction of a world-leading framework for decentralised and modular manufacturing in 2025, the MHRA is collaborating with the UK Space Agency and research-led pharmaceutical industry to adapt its regulatory model for medicines developed in microgravity and other emerging production environments.
In-Orbit Servicing, Assembly and Manufacturing is one of four Ministerial priorities for space that drives economic growth, reinforcing the strategic importance the UK government places on this sector. The MHRA and the UK Space Agency are jointly developing a collaborative regulatory roadmap, to be published in Autumn 2026, providing clarity on regulatory expectations for in-orbit manufacturing. This roadmap will be based on a generic, end-to-end in-orbit manufacturing model and will map each stage of the lifecycle against existing UK regulatory frameworks. The aim is to support developers by identifying applicable requirements, highlighting areas of regulatory overlap or uncertainty, and signposting pathways for compliance.
The microgravity advantage
Microgravity is the near absence of gravity, found in low Earth orbit. In this environment, effects like sedimentation and mechanical stress are much lower, so materials and biological systems behave differently. For pharmaceutical development, this creates new possibilities:
- Better drug formulations: Medicines could be redesigned for easier use, such as injections at home instead of hospital IV drips.
- Improved protein crystals: More uniform and purer crystal structures may help optimise the performance and quality of medicines
- Advanced and personalised therapies: Scientists can grow more realistic organoids and organ-on-a-chip systems, enabling personalised treatments and new cancer research approaches.
- Earth-based impact: Discoveries made in space can improve how drugs are formulated, manufactured and delivered on Earth.
For pharmaceutical and biotech companies, microgravity also offers emerging strategic benefits alongside scientific gains. Evidence from almost 500 biopharma experiments on the International Space Station shows strong potential for drug development innovation:
- First-mover advantage: Early adopters can build expertise and lead in novel manufacturing approach.
- Clearer regulation: The MHRA and UK Space Agency are actively collaborating to define pathways for in-orbit manufacturing, giving companies more certainty.
- Efficiency and cost benefits: Insights from space can improve manufacturing processes, reduce costs, and enable new delivery methods on earth.
In-orbit manufacturing is moving from concept to a capable reality
The rapid expansion of the commercial space sector has transformed access to microgravity. The growth of launch providers and orbital service companies, including SpaceX, Blue Origin and emerging European providers, has reduced costs and enabled more routine experimentation in low Earth orbit.
Access to microgravity is no longer limited to government missions but is supported by a growing range of platforms, including the International Space Station, commercial free-flyer satellites, and emerging orbital laboratories.
This transition from microgravity research to innovative commercial manufacturing is reflected in the market activity, with estimates suggesting space-enabled pharmaceutical development could generate between $2.8-4.2 billion in revenues highlighting the growing commercial interest in this emerging field.
Through partnerships with the European Space Agency and commercial collaborators, major pharmaceutical companies, alongside startups and academic groups, are already testing applications ranging from advanced drug formulations to regenerative medicine and novel delivery approaches.
As capabilities mature and proof-of-concept results generate compelling evidence, the question for pharmaceutical companies is no longer if microgravity has potential, but how to capitalise on it to deliver manufacturing innovation and health benefits on Earth.
Regulatory pathway backed by experience
The MHRA’s 2025 Decentralised Manufacture and Point of Care (DCM/POC) legislation applies across all pharmaceutical dosage forms and has built strong expertise in regulating advanced therapy manufacturing across decentralised and constrained settings, addressing automation, remote oversight, and limited human intervention - principles directly relevant to in-orbit manufacturing. Through initiatives such as the Regulatory Advice Service for Regenerative Medicine (RASRM), the MHRA has also demonstrated the value of early, structured engagement with innovators to iteratively refine regulatory approaches, a model now being extended to support emerging in-orbit manufacturing.
In practice, this means the MHRA is:
- Engaging early and directly with biopharma companies, space platform providers and engineering biology innovators to provide early advice on product development, manufacturing models and evidentiary requirements.
- Assessing how existing Good Manufacturing Practice (GMP), quality and Good Distribution Practice (GDP) frameworks apply to in-orbit production, applying risk-based, proportionate approaches where novel factors, such as environmental factors or payload logistics, need to be addressed.
- Working with partners to explore adaptive mechanisms where novel manufacturing concepts can be tested and refined in a controlled setting before full regulatory submission.
Shaping international norms
The UK is also working to shape emerging international norms for space-enabled biopharmaceutical manufacturing. This includes contributing to bilateral and multilateral engagement, including the inaugural UK-Swiss Microgravity Dialogue in June 2026, which brings together experts and senior decision-makers from space and pharmaceuticals to identity challenges and solutions for microgravity manufacturing and R&D.
This coordinated and collaborative approach positions the UK to actively inform the development of international standards, regulatory thinking and best practice for space‑enabled biopharmaceutical research and manufacturing. This is turn, delivers greater regulatory clarity, encourages international alignment where appropriate, and helps to create the environment for pharmaceutical companies to invest in the opportunities presented by microgravity.
Ask about Unlocking Space
To learn more about the collaborative work between MHRA and the UK Space Agency, or to engage with ongoing discussions around the regulatory pathway, contact: UnlockingSpace@dsit.gov.uk.
The MHRA Innovation Office welcomes queries regarding innovative medicines, novel manufacturing processes and regulatory challenges. This free and confidential service is available to organisations of all sizes and backgrounds, including academics, not-for-profit organisations, and patient groups.
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