About
Scientific advances have introduced innovative medicines using Non-Genetically Modified Organism technologies which are classed as Gene Therapies. Ex-Vivo Non-GMO Gene Therapy Medicinal Products are ATMPs and require Pharmacy oversight even when they are handled by another department within the same organisation or a third party provider. Examples of Ex-Vivo Non-GMO GTMPs include cell based medicines utilising gene editing technologies.
Separate guidance for Ex-Vivo Gene Therapies containing GMOs is available at https://www.sps.nhs.uk/articles/ex-vivo-cell-based-gene-therapy-medicinal-products-pharmacy-institutional-readiness-guidance/.
Purpose
The purpose of this document is to outline the key areas where Chief Pharmacists should focus pharmaceutical expertise prior to an organisation implementing any Ex-Vivo Non-Genetically Modified Organism Gene Therapies Medicinal Product (Non-GMO GTMP).
This document presents a flow diagram outlining a stepwise approach for implementation of processes to prepare and administer Non-GMO GTMPs. It is followed by checklists which relate to the various steps required and presented in the diagram.
Attachments
- Ex-Vivo Non-GMO GTMP Institutional Readiness V1.1 (Nov 25)Opens in a new window · Word · 229 KB
- Ex-Vivo Non-GMO GTMP Institutional Readiness V1.1 (Nov 25)Opens in a new window · PDF · 778 KB
Update history
- Minor editorial change on page 3.
- Published