Advanced therapy medicinal products
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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.
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.
Outsourcing ATIMP storage or preparation across legal boundaries
11 February 2026Guidance on the considerations for pharmacy clinical trial sites outsourcing activities involved in the delivery of ATIMPs.
Outsourcing marketed ATMPs: A template technical agreement
11 February 2026A template Quality Technical Agreement for outsourcing the receipt, storage, preparation and onward supply of marketed cryopreserved ATMPs.
Handling dry ice and vapour phase nitrogen shippers
11 February 2026Practical advice, training and competency assessments for pharmacy departments receiving shipments and storing medicines at ultra-low temperatures.
Supportive medicines guidance for adults on CAR-T cell therapy
11 February 2026This document provides expert clinical pharmacy guidance on supportive medicines in order to facilitate the treatment of complex CAR-T Cell Therapy patients.
Costing clinical trials of ATIMPs using the NIHR iCT
11 February 2026Guidance to support and promote consistent pharmacy costing for commercial clinical trials involving ATIMPs.
Diagnosing and managing acute CAR-T cell toxicities in adults
11 February 2026Consensus guidance (involving Wave 1 and 2 CAR-T centres) on the management of acute CAR-T cell toxicities.
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.