Phages for One Health: regulatory and product life cycle considerations

There is growing interest in bacteriophage (phage) technologies across the One Health spectrum. The UK Parliament's Science, Technology and Innovation Select Committee recently published the results of its inquiry into 'the antimicrobial potential of bacteriophages' with recommendations on clarity on regulatory matters to support research and innovation. Products developed for different sectors will have different regulatory requirements. Here, we discuss how phage technology is applied across human, veterinary and food sectors, highlighting key regulatory considerations and the technical challenges that must be addressed to assure the quality, safety and efficacy of phage products. We also highlight the potential impact of phages in areas where they are most needed (low- and middle-income countries).