Bacteriophage therapy: a regulatory perspective

Bacteriophage therapy may offer an alternative for managing infections due to MDR bacteria, but the approach needs to adhere to the existing regulatory framework and overcome current obstacles and shortcomings in scientific development.Despite the recognized problem of antibiotic multidrug resistance, very few antibacterial agents with new mechanisms of action are under development. Bacteriophage therapy could offer one alternative strategy to mitigate this challenge. Although widely used throughout the 20th century in Eastern Europe and the former Soviet Union, this potential therapy has not yet been investigated according to rigorous scientific standards. This paper reports on a multistakeholder meeting held at the EMA, which outlined the existing regulatory framework to which such therapy should adhere and reviewed the current obstacles and shortcomings in scientific development for bacteriophage therapy.