About
Scientific advances have introduced innovative medicines using Non-Genetically Modified Organism technologies which are classed as Gene Therapies. In-Vivo Non-GMO Gene Therapy Medicinal Products are ATMPs which are handled and manipulated by Pharmacies. Examples of Non-GMO GTMPs include mRNA based cancer immunotherapies of biological origin.
Separate guidance for In-Vivo Gene Therapies containing GMOs is available at https://www.sps.nhs.uk/articles/in-vivo-virus-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 In-Vivo Non-Genetically Modified Organism Gene Therapies Medicinal Products (Non-GMO GTMPs).
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.