Unlocking Space for Business: In-orbit R&D and manufacturing of pharmaceuticals RFI

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Description

The UK Space Agency is working across government, regulators, industry and healthcare to help create the conditions needed for the in-orbit pharmaceuticals manufacturing and drug discovery market to develop. USB has played a convening role in bringing together the Medicines and Healthcare products Regulatory Agency (MHRA), the Civil Aviation Authority (CAA) and the Regulatory Innovation Office (RIO) within the Department for Business, Innovation, Science and Trade (BIST) to publish a joint statement on regulatory clarity for in-orbit manufacturing of pharmaceuticals. We are also working with MHRA to develop a regulatory roadmap for space-enabled pharmaceutical manufacturing, to provide greater clarity and confidence for industry. Following sustained evidence-gathering from the Unlocking Space Portfolio, including participation in the recent UK-Swiss Microgravity Biopharma Dialogue, clear pain-points and barriers to the adoption of in-orbit manufacturing of pharmaceuticals have emerged, which are currently experienced by UK stakeholders including prospective end-users, space biotech companies and investors. This Request for Information (RFI) builds directly on this Dialogue, and the questions below are designed to test, validate and extend that evidence base with wider stakeholder input. The UK Space Agency requests your input to ensure that any future support or commercialisation opportunities for in-orbit manufacturing of pharmaceuticals or in-orbit R&D directly address these identified barriers and are prioritised based on the needs of stakeholders in this domain. This RFI will help guide the UK Space Agency’s interventions for space biopharma companies, prospective pharmaceutical end-users and space/biotech investors. This RFI is not directly connected to an existing funding route, but it may help to shape and inform future non-financial support interventions and commercial activities. We welcome your responses and are grateful in advance for the time and effort taken in replying to this Request for Information. Our aims – what we want to achieve The goals of this Request for Information are: To understand what existing and new barriers industry, end-users, academia and investors are facing on the commercialisation of IOM pharmaceuticals or in-orbit pharmaceuticals R&D, and the impact of these barriers; To understand what interventions have been effective at addressing these identified barriers and what new interventions would further support IOM pharmaceuticals or in-orbit pharmaceuticals R&D; and To understand where government is best placed to address these barriers and what international comparators we could learn from to inform potential future government interventions. This RFI is not related to any ongoing or future funding calls from the UK Space Agency, but it may help to shape and inform future non-financial support interventions and commercial activities. The UK Space Agency does not commit to cover any cost incurred in the preparation or submission of any response to the RFI.  Responding or failing to respond to this RFI will not preclude the respondents from participating in any future UK Space Agency calls or requests for information or other funding opportunities.  In recognition of stakeholder availability over the summer period, the deadline for responses is 17:00 BST, 7 September 2026. If more time is needed to provide a response or if there are additional questions about the process, please contact UKSA.commercial@dsit.gov.uk with “Unlocking Space for Business IOM Pharma RFI” as the subject line. An email confirmation of receipt from the UK Space Agency will be sent within a one-week period to the designated point of contact. The UK Space Agency reserves the right to follow-up and ask clarification questions on any responses.

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