Advanced therapy medicinal products
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Operating as an NHS clinical trial site post EU Exit
11 February 2026A summary of the implications of the UKs exit from the EU for clinical trial sites for both IMP and ATIMPs, including supply to and from Northern Ireland.
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.
Medication restrictions for CAR-T cell therapy
11 February 2026CAR-T Therapy requires some medicines to be restricted, this guidance provides details and recommended wash-out periods for restricted medicines.
Product design considerations for optimising ATMP implementation
11 February 2026This guidance provides advice for ATMP developers, highlighting implementation challenges faced by the NHS and suggesting design consideration to minimise them.
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.
Managing out of specification ATMPs
11 February 2026This document clarifies the regulatory expectation regarding OOS ATMPs and advises hospitals on governance in the event of an OOS ATMP being offered for use.
Outsourcing ATIMP handling: A template technical agreement
11 February 2026A template technical agreement for outsourcing the receipt, storage, preparation and onward supply of ATIMPs for clinical trial sites.
Performing preparation risk assessments for ATMPs
11 February 2026Preparation risk assessment tools for cell and tissue-based advanced therapy medicinal products (ATMPs) and in-vivo gene therapies.
Undertaking an audit of a cell therapy laboratory
11 February 2026A guide to performing audits of cell therapy laboratories where receipt, storage and handling of cell-based ATMPs has been outsourced by the pharmacy department
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.