Cross-border dialogue: An international survey of regulators on phage therapy

With antimicrobial resistance as a worldwide public health concern, bacteriophage (phage) therapy (PT) may help treat bacterial infections. However, given its particularities compared with traditional small molecule drugs, there are variations in how it is regulated worldwide. Regulators are key players governing PT, yet their perspectives have been largely unexplored. Here, we present findings from the first international survey aimed at capturing the current and future landscape of PT according to regulators. We distributed the survey to members of the second European Union-Joint Action on Antimicrobial Resistance and Healthcare-Associated Infections and individually contacted regulators. Results were collected between October 30, 2024 and March 26, 2025. Twenty-three respondents represented twenty-one countries across Europe, North America, Africa, and Oceania (response rate 67%). Phages or PT were reported as being mentioned in only three national action plans (13%). Nearly half of the respondents declared no prior involvement in phage-related regulatory processes in the past decade, and 32% were uncertain if phages have ever been used therapeutically in their country. Among those who were aware of previous in-country PT, single-use cases dominated, with 27% of respondents acknowledging this as a resource burden (compared to other regulatory applications). Some regulators reported that adapted frameworks are being explored for PT, while one indicated a new framework was being considered. These results underscore that globally major steps aimed at increasing awareness, engagement, and collaboration on best practices amongst regulators are still required to clarify and improve clinical access pathways for PT.