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

This first international survey of regulators highlights the fragmented and underdeveloped regulatory landscape for bacteriophage (phage) therapy (PT). Twenty-three respondents from 21 countries reported that PT is only mentioned in 3 national action plans (13%), and nearly half had no prior involvement in phage regulation. One-third were uncertain whether PT had ever been used therapeutically in their country, and where it had, cases were typically isolated and resource-intensive. While some countries are exploring adapted or new regulatory frameworks, overall awareness, engagement, and collaboration among regulators remain limited. Major efforts are needed globally to establish clearer and more consistent clinical access pathways for PT.