Requirements for Governance and Preparation of Gene Therapy: Pan UK Pharmacy Working Group for ATMPs

Gene therapies are an important class of ATMPs which horizon scanning indicates are becoming more available as both IMPs and marketed products. Pharmacy is often the first port of call when an organisation wishes to use a gene therapy and needs to provide pragmatic guidance to facilitate the introduction of these innovative products. This document is designed to give practical advice to centres wishing to undertake gene therapy trials and need to understand the requirements and recommendations for governance and, in particular to have in place a Genetic Modification Safety Committee. The document also gives practical advice for centres to help them understand operational requirements including deciding the optimal location for preparation.