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Pharmacy in space: mapping the EU legal landscape

As pharmaceutical research and manufacturing increasingly move into low Earth orbit (LEO), existing legal frameworks—designed for terrestrial, inspectable activities—face unprecedented challenges. This article maps the applicable law in low earth orbit, examines how EU regulations on clinical trials, GMPs, GCPs, pharmacovigilance, product liability, intellectual property and AI governance interact with international space law. It also assesses emerging responses including the UK’s 2026 space regulatory roadmap and the proposed European Union Space Act, concluding that targeted functional adaptations, rather than autonomous space health law, would offer the most pragmatic path forward to support health and space stakeholders’ research, development & innovation and help the market grow for a better prevention and treatment of diseases.

Released on Jul 15, 2026

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