噬菌体制剂应用及不同国家的审批情况

Application and global regulatory progress of phage preparations

关键词:  噬菌体治疗  应用  噬菌体制剂监管  注册审批

Key words:  phage therapy  applications  bacteriophage preparations regulation  Registration for approval

摘要:

全球耐药菌问题日趋严峻,严重威胁着人类和动物的生命健康。噬菌体可以专一地靶向杀灭有害菌而不会产生细菌耐药性问题,是解决全球耐药菌问题的有效途径。虽然噬菌体的研究已有百年历史,但是我国噬菌体制剂的审批仍处在摸索状态。本文总结了噬菌体制剂目前在人类和动物细菌性疾病的预防、治疗和环境消毒等方面应用现状,同时也搜集了噬菌体研究前沿国家的噬菌体制剂审批进展。希望可以有效推动噬菌体制剂在各大领域的应用,促进我国噬菌体制剂审批合法化进程。

Abstract:

The global problem of drug-resistant bacteria is becoming increasingly severe, posing a serious threat to the lives and health of humans and animals. Phages can specifically target and kill harmful bacteria without causing bacterial resistance issues, which is an effective way to solve the global problem of drug-resistant bacteria. Although the research on bacteriophages has a hundred years of history, the approval of bacteriophage preparations in China is still in a state of exploration. This article summarizes the current application status of bacteriophage preparations in the prevention, treatment, and environmental disinfection of human and animal bacterial diseases, and also collects the progress of bacteriophage preparation approval in cutting-edge countries in bacteriophage research. I hope to effectively promote the application of bacteriophage preparations in various fields and promote the legalization process of bacteriophage preparation approval in China.