Regulatory considerations for developing phage therapy medicinal products for the treatment of antimicrobial resistant bacterial infections.

ABSTRACT: Recently, there have been growing expectations that treatment of infections with bacteriophages (phages), viruses which specifically infect bacteria, can be used as a treatment option for antimicrobial resistant bacterial infections. In Europe and the United States, in addition to phage therapy as a form of personalized medicine, development of pre-defined phage therapy medicinal products (PTMPs) is progressing, and clinical trials are underway. From October 2024 to July 2025, the Pharmaceuticals and Medical Devices Agency exchanged opinions on trends and points to consider in drug development of PTMPs used for antimicrobial resistant bacterial infections with external experts. Development of PTMPs for regulatory approval requires quality control strategies, establishment of manufacturing

SUBMITTER: Fukaya-Shiba A 

PROVIDER: S-EPMC12756395 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature