中国化学药品通用名称的构建及监管  

Construction and Regulation of China Approved Drug Names(Chemical Drugs)

作　　者：周怡[1] 尤启冬[2] ZHOU Yi;YOU Qidong(Chinese Pharmacopoeia Commission,Beijing 100061,China;College of Pharmacy,China Pharmaceutical University,210009 Nanjing,China)

机构地区：[1]国家药典委员会,北京100061 [2]中国药科大学药学院,南京210009

出　　处：《药学与临床研究》2025年第1期1-3,共3页Pharmaceutical and Clinical Research

摘　　要：本文介绍国际非专利药名(INN)和中国药品通用名称(CADN)的命名基本原则,明确药品通用名称对于药品监管、医药贸易等的重要作用,使相关单位了解中国药品(化学药品)通用名称的核准过程。同时,分析中国药品(化学药品)通用名称命名核准面临的挑战,以促进中国药品(化学药品)通用名称核准工作的科学性、一致性和公平性。By overviewing the international nonproprietary name(INN)and Chinese approved drug names(CADN),this article clarifies the important role of generic names in drug regulation and drug trade.General nomenclature principles for INN and CADN(chemical drugs)are introduced to make the relevant organizations(MAH,Regulators etc.)understand the nomenclature process of CADN(chemical drugs).Simultaneously,challenges of the nomenclature are analyzed to ensure the scientific,consistent and fair work of nomenclature.

关 键 词：国际非专利药名 中国药品通用名称 命名原则 挑战 

分 类 号：R951[医药卫生—药学]