Regulatory clarity and new guidance aim to help firms bring microgravity-produced drugs from orbit to NHS patients

The UK government has announced a coordinated package of measures to support the development and regulation of medicines manufactured in space.

The steps set out a clearer route for companies to bring space-made drugs safely to market.

Led by jointly the UK Space Agency alongside the Medicines and Healthcare products Regulatory Agency (MHRA), the Regulatory Innovation Office and the Civil Aviation Authority, the initiative includes new regulatory guidance, case studies and a re-entry regulatory sandbox. 

It follows the UK government’s £2 billion “Life Sciences Sector Plan,” which identified in-orbit manufacturing as a priority area.

The microgravity environment of space cannot be replicated on Earth and can improve how biologic drugs form and behave in the human body, with potential benefits for patients with cancer and rare diseases.

Space Minister Liz Lloyd said the UK was “tackling the practical barriers that have held back commercial in-orbit manufacturing, from regulatory uncertainty to supply chain gaps.”

From orbit to patient

Dr Paul Bate, CEO of the UK Space Agency, said: “We want to ensure that promising microgravity research doesn’t stall at the experimental stage but progresses towards treatments that improve people’s lives.”

The MHRA’s Lawrence Tallon added: “Our existing medicines regulations already support advanced and novel manufacturing approaches, including those that take advantage of microgravity.”

Among the companies benefiting is BioOrbit, which received a £250,000 feasibility study to explore crystallising biologic drugs in space for at-home cancer treatments. 

Dr Katie King, BioOrbit’s CEO, said: “Britain isn’t watching from the sidelines; we’re leading it.”