Quality, safety and efficacy of bacteriophages as veterinary medicines - Scientific guideline

This document reflects the need for a guideline on quality, safety and efficacy of bacteriophages as veterinary medicines. While the Annex II of Regulation (EU) 2019/6 lays down some requirements for veterinary medicinal product specifically designed for bacteriophage therapy, there is a need for a more specific guidance applicable to these products.

Keywords: Novel therapies, bacteriophages, phages

Current version

Guideline on quality, safety and efficacy of veterinary medicinal products specifically designed for phage therapy

Consultation dates: 27/01/2023 to 31/05/2023AdoptedLegal effective date: 13/10/2023Reference Number: EMA/CVMP/NTWP/32862/2022

Concept paper on quality, safety and efficacy of bacteriophages as veterinary medicines

Consultation dates: 28/01/2022 to 29/04/2022Draft: consultation closedReference Number: EMA/CVMP/NTWP/438290/2021Summary:

This document reflects the need for a guideline on quality, safety and efficacy of bacteriophages as veterinary medicines. While the Annex II of Regulation (EU) 2019/6 lays down some requirements for veterinary medicinal product specifically designed for bacteriophage therapy, there is a need for a more specific guidance applicable to these products.

Document history

Overview of comments received on 'Guideline on quality, safety and efficacy of veterinary medicinal products specifically designed for phage therapy'

Reference Number: EMA/CVMP/NTWP/230544/2023