Product Design Considerations for Optimising ATMP Implementation in the NHS

Anne Black, Regional QA Specialist Pharmacist, NHS SPSPublished

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

This guidance provides practical advice for the development of Advanced Therapy Medicinal Products (ATMPs) to ensure their suitability for NHS implementation. This document is aimed at industry and researchers in the ATMP field and encourages developers to reverse engineer to deliver products that can be successfully integrated within the hospital ecosystem. Implementation challenges faced by the NHS and experience with ATMPs in clinical trials, as well as licenced and unlicensed ATMPs, are highlighted with the aim of encouraging developers to take them into consideration throughout the product development lifecycle.

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