Space Manufacturing Meets Regulation: It's Happening Faster than Expected

A few weeks ago, I shared some thoughts on the regulatory intersections between space activities and life sciences (including food), from space breeding to microgravity biomanufacturing, and the legal questions they raise.

Since then, the UK has moved first.

In a joint statement, the UK Space Agency, the MHRA, and the Regulatory Innovation Office and the Civil Aviation Authority (CAA) made clear that they are already working on guidance, regulatory sandboxes, case studies and stakeholder engagement for in-orbit pharmaceutical manufacturing, especially biologics and protein-based medicines. In microgravity, crystallisation, stability, and manufacturing performance may improve. But the broader implications go well beyond pharma.

This does not come out of nowhere. The UK already has a statutory basis in the Space Industry Act 2018, which regulates space activities and subjects spaceflight activities and spaceports to licensing.

What makes this development particularly interesting is not only its focus on in-orbit pharmaceutical manufacturing, but the regulatory method behind it. The statement shows public authorities beginning to treat space not merely as a research playground, but as a production environment requiring coordination across licensing, product regulation, re-entry, safety and supply chains.

By combining guidance, principles-based case studies and a regulatory sandbox, this initiative supports innovation while maintaining oversight. It also promotes regulatory alignment and clearer pathways for emerging space-enabled life sciences technologies.

Companies developing such technologies are encouraged to engage early with MHRA’s scientific and regulatory advice services to better understand applicable pathways, development considerations and compliance requirements.

That approach is broadly consistent with the UK Space Regulatory Review 2024, which called for greater clarity, less administrative burden in licensing, and a more streamlined and transparent process.

The EU, by contrast, is moving at a different regulatory level. The proposed EU Space Act is designed first to establish a harmonised framework for space activities, reduce fragmentation across Member States, and make the internal market more workable, including for start-ups and SMEs. More detailed technical requirements will then need to be developed through implementing measures and guidance.

At the Member State level, however, there is no reason to wait passively. National authorities can already do more by creating regulatory sandboxes and clearer pathways that help de-risk innovation for operators, including start-ups and SMEs.