Public consultation on new general chapter on phage therapy active substances and medicinal products for human and veterinary use in Pharmeuropa 35.2关于《欧洲药典》（Pharmeuropa 35.2）中噬菌体治疗活性物质和人用及兽用医药产品新总则的公众咨询Public consultation on new general chapter on phage therapy active substances and medicinal products for human and veterinary use in Pharmeuropa 35.2
EDQM STRASBOURG, FRANCE 06/04/2023
法国，斯特拉斯堡，EDQM 06/04/2023
At its 170th session (June 2021), the European Pharmacopoeia Commission (EPC) agreed to elaborate a new general chapter, Phage therapy active substances and medicinal products for human and veterinary use (5.31),and assigned the task to the newly created Bacteriophages Working Party (BACT WP).
在第 170 届会议（2021 年 6 月）上，欧洲药典委员会（EPC）同意制定一个新的总章节–噬菌体治疗活性物质和人用及兽用医药产品（5.31），并将该任务分配给新成立的噬菌体工作组（BACT WP）。
Phage therapy – the use of naturally occurring bacterial viruses (bacteriophages or phages) to treat bacterial infections – was first described in the early 20th century, but only remained in active use in a few countries. In recent years, however, phage therapy has regained the interest of physicians, researchers and industry as an attractive alternative to antibiotic treatment, particularly in the face of rising levels of antimicrobial resistance, increasingly frequent disruptions in antibiotic supply and an unmet demand for new antibiotics.
噬菌体疗法–利用天然细菌病毒（噬菌体或噬菌体）治疗细菌感染–最早出现于 20 世纪初，但只在少数几个国家得到了积极应用。然而，近年来，噬菌体疗法作为抗生素治疗的一种有吸引力的替代疗法，重新引起了医生、研究人员和工业界的兴趣，尤其是在抗菌素耐药性不断上升、抗生素供应中断日益频繁以及对新抗生素的需求得不到满足的情况下。
Addressing the quality of phage therapy has therefore been identified as a significant ongoing project for the EPC in the field of biologicals, and fulfilling the increasing expectations of users and being prepared for the future developments in this fast-moving field are amongst the EPC’s priorities for 2023-2025.
因此，解决噬菌体疗法的质量问题已被确定为 EPC 在生物领域的一个重要持续项目，满足用户日益增长的期望并为这一快速发展领域的未来发展做好准备是 EPC 在 2023-2025 年的优先事项之一。
Elaborated by the BACT WP in response to these needs, the draft general chapter has now been published in Pharmeuropa 35.2, where it will remain open for public consultation from April until the end of June 2023. All interested parties are encouraged to review it and submit their comments. For more information on how to comment, please consult our guide.
根据这些需求，BACT WP 拟定了通用章节草案，现已在 Pharmeuropa 35.2 上发布，并将于 4 月至 2023 年 6 月底进行公开咨询。我们鼓励所有相关方审阅并提交意见。有关如何发表意见的更多信息，请查阅我们的指南。
View original version: https://www.edqm.eu/en/-/public-consultation-on-new-general-chapter-on-phage-therapy-active-substances-and-medicinal-products-for-human-and-veterinary-use-in-pharmeuropa-35.2