Yang Qimao, Le Shuai, Zhu Tongyu, Wu Nannan
CreatiPhage Biotechnology Co., Ltd., Shanghai, China.
Department of Microbiology, Army Medical University, Chongqing, China.
Front Microbiol. 2023 Oct 6;14:1250848. doi: 10.3389/fmicb.2023.1250848. eCollection 2023.
Phage therapy, a century-long treatment targeting bacterial infection, was widely abandoned after the clinical availability of antibiotics in the mid-20th century. However, the crisis of antimicrobial resistance today led to its revival in many countries. While many articles dive into its clinical application now, little research is presenting phage therapy from a regulatory perspective. Here, we focus on the regulations of phage therapy by dividing sections into Eastern Europe where it was never abandoned and Western Europe, Australia, the United States, India, and China where it only re-attracted researchers' attention in recent decades. New insights about its regulations in China are provided as little English literature has specifically discussed this previously. Ultimately, by introducing the regulations in phage therapy for human health across representative countries, we hope to provide ideas of how countries may borrow each other's adapting legislation in phage therapy to best overcome the current regulatory hurdles.
噬菌体疗法是一种针对细菌感染的长达一个世纪的治疗方法，在20世纪中叶抗生素临床可用后被广泛摒弃。然而，如今的抗菌耐药性危机导致其在许多国家复兴。虽然现在有许多文章深入探讨其临床应用，但从监管角度介绍噬菌体疗法的研究却很少。在这里，我们通过将地区划分为从未放弃噬菌体疗法的东欧以及近几十年来才重新引起研究人员关注的西欧、澳大利亚、美国、印度和中国，来聚焦噬菌体疗法的监管情况。由于此前很少有英文文献专门讨论过中国的情况，因此本文提供了关于中国噬菌体疗法监管的新见解。最终，通过介绍不同代表性国家针对人类健康的噬菌体疗法监管情况，我们希望能为各国在噬菌体疗法中借鉴彼此适应性立法以最佳方式克服当前监管障碍提供思路。
