Abstract

There is increasing interest in the use of bacteriophages in human and veterinary medicine as part of the global battle against antimicrobial resistance. Significant biological, regulatory and financial challenges exist in bringing bacteriophage products to market, making guidance on bacteriophage products a priority for regulatory agencies. Whilst the biological challenges are common between human and veterinary domains, the regulatory and commercial challenges differ widely between these two sectors.

In November 2024, the International Alliance for Biological Standardization (IABS) brought together experts from both human and veterinary sectors at a meeting titled ‘Avoiding Antimicrobial Resistance: Veterinary use of Phages for Prevention, Therapy and Control of Bacterial Infections’. The meeting highlighted the complexity of bringing bacteriophage products to the veterinary sector where they may be marketed as veterinary medicinal products, magistral preparations, feed additives, biocides or conditioners for foodstuffs of animal origin. Classification depends on the nature of the product, the form and method of administration, the claims made, and the regulatory framework of the jurisdiction in which the product is marketed. It is possible that access to the veterinary market would be better promoted if there was greater regulatory alignment between jurisdictions and if information and advice were more readily available to help manufacturers decide on the best drug development strategy.

This article describes the main regulatory challenges for developing bacteriophage-based products for use in animals and presents an analysis of the key messages from the meeting that may interest regulators and manufacturers as they seek to promote the use of phage products in animal husbandry and food production in the interests of reducing antimicrobial resistance (AMR).