英国药典2024年版概览  

Overview of the British Pharmacopoeia 2024

作　　者：赵慧芳[1] 陈唯真[1] 王雅雯[1] ZHAO Hui-fang;CHEN Wei-zhen;WANG Ya-wen(National Institutes for Food and Drug Control,Beijing100050,China)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国新药杂志》2025年第3期249-255,共7页Chinese Journal of New Drugs

摘　　要：英国药典(British Pharmacopoeia,BP)在药品领域具有较高的国际影响力,受到业内专家学者的广泛关注。BP每年修订一次,修订内容不仅保持与欧洲药典同步,还包含对部分本国药品标准的增减及完善。新版BP的出版进一步巩固了其在国际上关于国家药品标准制定中的权威地位,为全球保障药品质量和安全发挥了重要作用。基于上版BP,本文总结归纳了BP 2024年版在总论、各论和附录等方面的修订情况,包括新增38个各论、删减17个各论、技术修订84项、修订8个各论的标题,同时为细胞和基因治疗领域制定了多个非强制性指导原则,推进分析质量源于设计概念的研究与实施等,希望能为BP的使用者和《中华人民共和国药典》的编制提供参考。The British Pharmacopoeia(BP)holds significant international influence in the pharmaceutical field and is closely concerned by experts and scholars in this field.The BP undergoes annual revisions,which not only keeps pace with the European Pharmacopoeia,but also incorporates additions,omissions,and improvements to some domestic drug standards.The publication of the new edition of BP further solidifies its authoritative position in the formulation of international drug standards,and provides a solid guarantee for the quality and safety of medicines worldwide.Based on the previous edition of BP,this article summarizes the revisions made in the 2024 edition on general monographs,specific monographs,appendices and other aspects,including additions of 38 monographs,omissions of 17 monographs,technical changes of 84 items and title changes of 8 monographs,etc.,as well as publishing several sets of non-mandatory guidance for the cell and gene therapy community and continuing to investigate and engage in the application of analytical quality by design(AQbD)concepts.It is hoped that this article will serve as a valuable reference for pharmacopoeia users and the revision of the Chinese Pharmacopoeia.

关 键 词：英国药典 总论 各论 附录 比较 

分 类 号：R921.2[医药卫生—药学]