20 August 2021 · This guidance provides advice for ATMP developers, highlighting implementation challenges faced by the NHS and suggesting design consideration to minimise them.
27 September 2019 · Regulatory export requirements for hospitals procuring (harvesting) patient’s own cells/tissues for use as starting materials in the manufacture of ATMPs.
12 July 2022 · CAR-T Therapy requires some medicines to be restricted, this guidance provides details and recommended wash-out periods for restricted medicines.
16 April 2024 · Bringing together NHS experts and regulators covering topics of quality assurance, quality control, good manufacturing practice and regulatory expectations.
24 February 2020 · This document clarifies the regulatory expectation regarding OOS ATMPs and advises hospitals on Governance in the event of an OOS ATMPs being offered for use.