April 2024

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

PHAGE THERAPY ACTIVE SUBSTANCES AND MEDICINAL PRODUCTS FOR HUMAN AND VETERINARY USE 5.31. 人用和兽用噬菌体治疗活性物质和药品 PHAGE THERAPY ACTIVE SUBSTANCES AND MEDICINAL PRODUCTS FOR HUMAN AND VETERINARY USE 出版这一通则是为了提供参考。 This general chapter is published for information. 它为人用和兽用噬菌体治疗活性物质和药品及其生产和控制提供了要求框架。 It offers a framework of requirements for phage therapy active substances and medicinal products for human and veterinary use and

Quality and Safety Requirements for Sustainable Phage Therapy Products可持续噬菌体疗法产品的质量和安全要求 Abstract 摘要 The worldwide antibiotic crisis has led to a renewed interest in phage therapy. Since time immemorial phages control bacterial populations on Earth. Potent lytic phages against bacterial pathogens can be isolated from the environment or selected from a collection in a matter of days. In

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