Advanced therapy medicinal products
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Product Design Considerations for Optimising ATMP Implementation in the NHS
20 August 2021This guidance provides advice for ATMP developers, highlighting implementation challenges faced by the NHS and suggesting design consideration to minimise them.
Advanced therapy medicinal products
Advice, guidance and individual details for specific advanced therapy medicinal products.
Handling Dry Ice and Vapour Phase Nitrogen Shippers - Advice for Hospital Pharmacies
16 October 2020Practical advice, training and competency assessments for pharmacy departments receiving shipments and storing medicines at ultra-low temperatures.
Tissue Engineered Products - Pharmacy Institutional Readiness Guidance
21 July 2020This document outlines key areas for focus of pharmaceutical expertise prior to an organisation implementing Tissue Engineered Products.
Out of Specification Advanced Therapy Medicinal Products - Guidance for Healthcare Organisations
24 February 2020This document clarifies the regulatory expectation regarding OOS ATMPs and advises hospitals on Governance in the event of an OOS ATMPs being offered for use.
Pharmacy Oversight and Supervision Requirements for Preparation of Licensed ATMPs
31 January 2020This guidance provides definitions of oversight and supervision it clarifies where each are required when implementing ATMPs.
Regulatory requirements for export of ATMP starting materials: Pan UK Pharmacy Working Group on ATMPs
27 September 2019Regulatory export requirements for hospitals procuring (harvesting) patient’s own cells/tissues for use as starting materials in the manufacture of ATMPs.
Pharmacy Institutional Readiness for Marketed CAR-T Therapy: Guidance for Chief Pharmacists V4 (updated January 2020)
2 October 2018This document outlines key areas where Chief Pharmacists should focus pharmaceutical expertise prior to an organisation implementing CAR-T Therapy.
(ATMPs)-The Role of Pharmacy in the Successful Delivery of Advanced Therapy Medicinal Products Information for Chief Pharmacists
7 August 2017Advice for Chief Pharmacists on Governance arrangements to ensure that ATMPs are of suitable quality and safe to use.