Bacteriophage-based veterinary products: aligning regulatory framework and development challenges for market integration

The emergence of antimicrobial resistance renewed the interest in bacteriophages as complementary interventions to the use of antibiotics in veterinary medicine. The IABS workshop entitled “Avoiding Antimicrobial Resistance: Veterinary Use of Phages for Prevention, Therapy and Control of Bacterial Infections” brought together experts to discuss the scientific, regulatory and commercial challenges involved in bringing phage-based products to market. The biological characteristics of phages require innovative approaches for product development and regulatory approval. Dependent on their actual use, phages could be marketed as veterinary medicinal products, magistral preparations, food additives, or biocides, each classification implying different regulatory requirements and challenges, and none of which were originally intended for phage-based products. The meeting highlighted the need for regulatory harmonization to facilitate market access and allow manufacturers to choose the most appropriate regulatory pathway for their products. Recent EMA and EDQM guidelines offer some flexibility to take into account the biological nature of phages, but concerns remain about the feasibility of manufacturing phage-based products following existing rules for veterinary chemotherapeutants at commercially viable costs. Overcoming these regulatory and financial barriers is essential for the integration of phage therapy as a therapeutic option for control of bacterial infection and disease in veterinary medicine.