DQM STRASBOURG, FRANCE 10/04/2024
法国，斯特拉斯堡，EDQM 10/04/2024
Rising levels of antimicrobial resistance in recent years, identified as one of the leading threats to global public health and development, have prompted renewed interest in the use of phage therapy for the treatment of bacterial infections. This led the European Pharmacopoeia Commission (EPC) to make the elaboration of European Pharmacopoeia (Ph. Eur.) texts standardising requirements for phage therapy one of its top priorities for the years 2023-2025.
近年来，抗菌药耐药性不断上升，被认为是全球公共卫生和发展面临的主要威胁之一，这促使人们对使用噬菌体疗法治疗细菌感染重新产生了兴趣。这促使欧洲药典委员会（European Pharmacopoeia Commission，EPC）将制定欧洲药典（Ph. Eur.）文本、规范噬菌体疗法的要求作为 2023-2025 年的首要任务之一。
Phage therapy medicinal products (5.31), the first such text, was adopted by the EPC at its 178th session held on 19 and 20 March 2024. This new general chapter provides a framework of requirements for the production and control of phage therapy products and allows a degree of flexibility commensurate with the complex approaches currently employed in this emerging and rapidly developing field.
噬菌体治疗药物产品（5.31）是第一个此类文本，在 2024 年 3 月 19 日和 20 日举行的第 178 届会议上获得欧洲共同体委员会通过。这一新的总章为噬菌体疗法产品的生产和控制提供了一个要求框架，并允许一定程度的灵活性，以适应这一新兴和快速发展领域目前采用的复杂方法。
Phage therapy medicinal products is the first up-to-date text of its kind to be published in a pharmacopoeia and, given the high interest in the subject matter for the reasons described above, the EPC also decided to exceptionally pre-publish the text on the website of the European Directorate for the Quality of Medicines & HealthCare (EDQM) pending its publication in Supplement 11.6 (July 2024).
噬菌体疗法药物产品是第一部在药典中出版的同类最新文本，鉴于上述原因对该主题的高度关注，欧洲药典委员会还决定在《补编 11.6》（2024 年 7 月）出版之前，例外地在欧洲药品和保健质量管理局（EDQM）的网站上预先出版该文本。
The Ph. Eur. Bacteriophage Working Party will now focus its efforts on elaborating the general chapter on bacteriophage potency determination that was added to the work programme at the 176th EPC session in June 2023.
噬菌体工作组现在将集中精力制定关于噬菌体效力测定的一般章节。噬菌体工作组现在将集中精力，详细阐述 2023 年 6 月第 176 届 EPC 会议工作计划中增加的关于噬菌体效力测定的一般章节。
Original version source: https://www.edqm.eu/en/-/new-general-chapter-on-phage-therapy-medicinal-products-5.31-adopted-and-pre-published-on-the-edqm-website