16 October 2020 · Practical advice, training and competency assessments for pharmacy departments receiving shipments and storing medicines at ultra-low temperatures.
21 July 2020 · This document outlines key areas for focus of pharmaceutical expertise prior to an organisation implementing Somatic Cell Therapy Product.
21 July 2020 · This document outlines key areas for focus of pharmaceutical expertise prior to an organisation implementing Tissue Engineered Products.
21 July 2020 · This document outlines key areas for focus of pharmaceutical expertise prior to an organisation implementing Ex-Vivo (cell based) Gene Therapy.
21 July 2020 · This document outlines key areas for focus of pharmaceutical expertise prior to an organisation implementing In-Vivo (virus based) Gene Therapy.
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.
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.