MHRA guidance on development and use of phage therapies

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published the UK’s first official guidance to support the safe development and use of phage therapies - treatments that use viruses to target and destroy harmful bacteria.

This guidance aims to help researchers and companies develop phage-based medicines that meet UK safety, quality and efficacy standards. It covers both combined phage products designed for common infections and circulating strains, as well as personalized phage therapies that are tailored for individual patients with rare or highly resistant infections.

The result could be access to phage treatment when standard-of care-antibiotics fail or cannot be given, for example due to allergies. While some patients in the UK have already received phage therapy under compassionate use - with phages imported from abroad - there are currently no licensed phage medicines on the UK market.