The UK’s regulatory framework for human tissues and cells continues to evolve, shaped both by post‑Brexit requirements and significant changes within the EU, including the adoption of the new Substances of Human Origin (SoHO) Regulation. These developments have important implications for the import and export of tissues and cells used as starting materials for the manufacture of advanced therapy medicinal products (ATMPs).
This Centre of Excellence in Regulatory Science and Innovation for Advanced Therapies (CERSI-AT) white paper provides a summary of the current UK landscape alongside the emerging EU framework, and examines the associated operational and regulatory challenges faced by organisations transporting tissues and cells across borders. Drawing on stakeholder engagement led by the CGT Catapult, the paper highlights educational, operational and policy considerations that point toward a more coordinated, harmonised approach.
Stakeholder‑driven recommendations focus on opportunities to strengthen the UK environment, including developing guidance and educational materials, using technology to support knowledge‑sharing, maintaining alignment with EU requirements, continuing UK involvement in global harmonisation efforts, and enhancing collaboration across regulatory authorities.
Improving these areas could reduce administrative burden, support timely patient access, and enhance the UK’s ability to operate effectively within the global ATMP supply chain.
