Quality aspects of phage therapy medicinal products

The aim of this guideline is to clarify the regulatory expectations for quality documentation of bacteriophage active substances and finished products for human use within marketing authorisation applications. It addresses specific aspects regarding the manufacture, control of materials, characterisation, specifications, analytical control, reference standards and stability of bacteriophage active substances. In addition, guidance is given on the pharmaceutical development, manufacture, control and stability of the finished product.

Keywords: Guideline, Bacteriophage, Phage Therapy, Development and Manufacture, Active Substance, Finished Product, Antimicrobial Resistance

Current version

Draft guideline on quality aspects of phage therapy medicinal products

Draft: consultation open Consultation dates: 23/10/2025 to 30/04/2026 Reference Number: EMA/CHMP/BWP/1/2024 Summary:

Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

Concept paper on the establishment of a guideline on the development and manufacture of human medicinal products specifically designed for phage therapy

Draft: consultation closed Consultation dates: 22/12/2023 to 31/03/2024 Reference Number: EMA/CHMP/BWP/486838/2023