Abstract:We have entered into post-antibiotic era, phage therapy has been refocused recently, bacteriophages are different from the normal antibiotics. It is unsuitable to use the established safety assessment system for classical antimicrobial agents to evaluate the safety of bacteriophages for therapy. So, it is necessary to establish the safety assessment system of phage therapy involved in the whole procedures of choosing bacteriophages, including phage production, the choice of bacteriophage products, phage's administration routes, and the bacterial infection patients that enrolled for phage therapy. In this study, we systematically analyzed the safety problem involved in phage therapy and established the safety assessment system of phage therapy. It can provide basis for phages to enter into clinical therapy in the future.