Service advice and planning
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Exporting ATMP starting materials
11 February 2026Regulatory export requirements for hospitals procuring (harvesting) patient’s own cells/tissues for use as starting materials in the manufacture of ATMPs.
Exagamglogene autotemcel (Casgevy®)
13 February 2026This document highlights key areas where Chief Pharmacists should focus pharmaceutical expertise prior to implementation of exagamglogene autotemcel.
Ex-vivo non-GMO gene therapy medicinal products
13 February 2026This document outlines key areas for focus of pharmacy expertise prior to an organisation implementing ex-vivo non-genetically modified organism gene therapies.
Ex-vivo GMO gene therapy medicinal products
13 February 2026This document outlines key areas for focus of pharmacy expertise prior to an organisation implementing ex-vivo genetically modified organism (GMO) gene therapy.
Constructing a pharmacy manual for clinical trials
12 December 2022Sponsor pharmacy must construct a pharmacy manual when required by sites hosting clinical trials
Closing clinical trials
12 December 2022Sponsor pharmacy responsibilities during trial closure and the final monitoring visit
Bank and agency staff and Patient Group Directions
23 April 2024The below summarises the advice on the use of PGDs by bank and agency staff working within organisations.
Assuring Investigational Medicinal Product (IMP) supply
22 September 2022Sponsor pharmacy role regarding the supply assurance of Investigational Medicinal Products (IMPs) in CTIMPs
Assurance of aseptic preparation of medicines
21 March 2023Updated guidance from NHSE to reflect governance and visibility of the assurance and audit of unlicensed aseptic preparation
Additional considerations for single or multi-centre trials
8 December 2022Ensure the correct process is followed depending on whether it is a single or multi-centre trial sponsored by an NHS organisation