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 In-vivo GMO gene therapy medicinal products (SPS page).
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.
Attachments
- In-Vivo Non-GMO GTMP Institutional Readiness V1 (Oct 25)Opens in a new window · PDF · 713 KB
- In-Vivo Non-GMO GTMP Institutional Readiness V1 (Oct 25)Opens in a new window · Word · 198 KB
Update history
- Title amended.
- Published