The UK is clarifying the process for safely bringing space-manufactured drugs to market, with the aim of providing patients with more effective, higher-quality and longer-lasting medicines.
The microgravity environment, unique to space and impossible to replicate on Earth, can improve how biologic drugs form, behave and function, potentially enhancing outcomes for cancer, rare diseases and other conditions by increasing the quality, stability and effectiveness of complex medicines.
UK companies working on space-developed medicines will now benefit from measures announced today to support rapid in-orbit manufacturing growth.
These include clearer regulatory guidance and easier pathways from space research to patient treatments, aligning with the UK’s £2bn Life Sciences Sector Plan to expand treatment options and improve health outcomes.
Led by the UK Space Agency and supported by the Medicines and Healthcare products Regulatory Agency (MHRA), the Regulatory Innovation Office (RIO) within the Department for Science, Innovation and Technology (DSIT) and the Civil Aviation Authority (CAA), this package offers regulatory guidance, case studies, a regulatory sandbox and enhanced supply-chain engagement.
This clarity will help the UK facilitate the industry's efforts to deliver space-made medicines more effectively to patients.
Lord David Willetts, Chair of the UK Space Agency and Regulatory Innovation Office, said: "In-orbit manufacturing of pharmaceuticals represents a significant opportunity for the UK, combining the growth potential of our space sector with the promise of better treatments for patients."
"The UK Space Agency is committed to supporting the companies pioneering this work, from microgravity platform providers to biotech and pharmaceutical firms."
"Setting out a clear adoption pathway with well-defined regulatory requirements gives investors and entrepreneurs the confidence they need to bring these innovations to market."
The UK is open for business in space-enabled pharmaceuticals, with the ambition and capability to lead globally.
The government is prioritising in-orbit servicing, assembly and manufacturing to boost UK leadership, growth and security.
The UK’s regulatory environment will aim to support innovative pharmaceutical and spaceflight models. Missions such as Space Forge’s ForgeStar 1 and Astroscale UK’s ELSA D demonstrate that in orbit manufacturing is feasible.
The UK Space Agency invests in early projects, including a £250,000 feasibility study for BioOrbit, a start-up developing space-based biologic drug crystallisation for at-home cancer treatments.
To foster growth, the government is creating new guidance, launching a Re-entry Regulatory Sandbox and streamlining licencing for frequent in orbit operations.
The UK Space Agency and MHRA's Innovation Accelerator stated that they are preparing case studies to clarify regulatory paths for space, biotech and pharma companies.
Dr Paul Bate, CEO of the UK Space Agency, stated: "Our investment in innovative projects is matched by focused work through our Unlocking Space Portfolio to connect space companies with the pharmaceutical sector and public health partners."
We want to ensure that promising microgravity research doesn’t stall at the experimental stage but progresses towards treatments that improve people’s lives.
"This is about turning the UK’s strengths in space and life sciences into a competitive advantage that delivers for patients and for growth."
Building on the MHRA’s experience with innovative regulatory pathways, including the 2025 launch of a decentralised, modular manufacturing framework, the Agency collaborates with developers and partners to ensure regulations are suitable for medicines made using advanced methods.
This includes manufacturing in microgravity or other unique environments with modular and atypical distribution practices.
Lawrence Tallon, CEO at the MHRA, added: "The UK is well placed to enable safe, cutting-edge innovation in space-enabled biomanufacturing."
Our existing medicines regulations already support advanced and novel manufacturing approaches, including those that take advantage of microgravity.
“Through joint case studies and early scientific and regulatory advice, the MHRA is helping to shape a clear pathway from in-orbit manufacture to patient access—supporting innovation while maintaining the highest standards of safety, quality and patient protection."