EMA draft guideline on quality aspects of phage therapy medicinal products

The European Medicines Agency's draft guideline on quality aspects of phage therapy medicinal products (EMA/CHMP/BWP/1/2024) clarifies the regulatory expectations for quality documentation of bacteriophage active substances and finished products for human use in marketing authorisation applications, covering manufacture, control of materials, characterisation, specifications, analytical control, reference standards and stability. It was first published on 24 October 2025; the public consultation ran from 23 October 2025 to 30 April 2026 and is now closed.