Advanced therapy medicinal products

Topics: Advanced therapy medicinal products

Advice, guidance and individual details for specific advanced therapy medicinal products.

Advice and guidance

Outsourcing marketed ATMPs: A template technical agreement

A template Quality Technical Agreement for outsourcing the receipt, storage, preparation and onward supply of marketed cryopreserved ATMPs.

Supportive medicines guidance for adults on CAR-T cell therapy

This 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

Guidance to support and promote consistent pharmacy costing for commercial clinical trials involving ATIMPs.

Handling dry ice and vapour phase nitrogen shippers

Practical advice, training and competency assessments for pharmacy departments receiving shipments and storing medicines at ultra-low temperatures.

Operating as an NHS clinical trial site post EU Exit

A 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.

Requirements for governance and preparation of gene therapy

Practical advice for centres implementing gene therapies detailing governance requirements and optimal preparation location decision making support.

Outsourcing ATIMP storage or preparation across legal boundaries

Guidance on the considerations for pharmacy clinical trial sites outsourcing activities involved in the delivery of ATIMPs.

Diagnosing and managing acute CAR-T cell toxicities in adults

Consensus guidance (involving Wave 1 and 2 CAR-T centres) on the management of acute CAR-T cell toxicities.

Product design considerations for optimising ATMP implementation

This guidance provides advice for ATMP developers, highlighting implementation challenges faced by the NHS and suggesting design consideration to minimise them.

Exporting ATMP starting materials

Regulatory export requirements for hospitals procuring (harvesting) patient’s own cells/tissues for use as starting materials in the manufacture of ATMPs.