Governance
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Requirements for governance and preparation of gene therapy
11 February 2026Practical advice for centres implementing gene therapies detailing governance requirements and optimal preparation location decision making support.
Exporting ATMP starting materials
11 February 2026Regulatory export requirements for hospitals procuring (harvesting) patient’s own cells/tissues for use as starting materials in the manufacture of ATMPs.
Pharmacy oversight and supervision when preparing cellular ATMPs
11 February 2026This guidance provides definitions of oversight and supervision and clarifies where each are required when implementing ATMPs.
Advice for Chief Pharmacists on ATMP governance requirements
10 February 2026Advice for Chief Pharmacists on governance arrangements to ensure that ATMPs are of suitable quality and safe to use.