The role of pharmacy
Gene therapies are an important class of ATMPs which 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.
Service design and implementation
The following document is designed to give advice to centres wishing to undertake gene therapy trials, or introducing a marketed gene therapy. Centres need to understand the requirements and recommendations for governance, including the place of 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.
Gene therapy guidance
The version 3 (Feb 2024) updated guidance now also includes:
- gene therapies which are not classed as genetically modified organisms (including mRNA immunotherapies)
- the use of unlicensed gene therapies
- deliberate release considerations
- updated waste guidance
Acknowledgements
With thanks to the Pan UK Pharmacy Working Group for ATMPs.