MHRA publishes the UK's first official guidance on developing phage therapies

On 4 June 2025 the UK Medicines and Healthcare products Regulatory Agency (MHRA) published the UK's first official guidance to support the safe development and use of phage therapies, covering both combined phage products for common infections and personalised phage therapies tailored to individual patients. The 28-page document sets out the evidence needed for clinical trials and market authorisation, quality and Good Manufacturing Practice standards, how personalised treatments can be developed and supplied, and when unlicensed phage treatments can be used for individual patients.