EMA adopts guidelines on veterinary medicinal products for phage therapy.

On October 5th, 2023, the European Medical Agency adopted guidelines on the quality, safety, and efficacy of veterinary medicinal products (VMPs) designed for phage therapy.

The aim of the guidelines is to provide clear “regulatory/technical and scientific requirements” for veterinary medicinal products specifically for use in phage therapy and composed of bacteriophages.

Phage therapy refers to the usage of bacteriophage to prevent or treat disease via the anti-bacterial lytic effects of bacteriophages.

Regulation for this group of medicines is unique in that VMPs designed for phage therapy are likely to require varied composition over time due to the high host specificity of phages, and the inevitability of phage resistance. This is referenced in Annex II of Regulation (EU) 2019/6, under which phage therapy are regulated as novel therapies (NTs).

The guidelines cover the following:

  • Administrative information
  • Quality documentation
  • Safety documentation
  • Efficacy documentation
  • Concomitant use of bacteriophages with antibiotics
  • Post marketing authorisation changes

The move marks a welcomed development in the regulatory landscape for phage therapy in Europe, with the virus-based therapy representing an additional tool in treatment of resistant infections and a potential alternative to antibiotic therapy.