黏膜给药中成药临床应用药物警戒指南  

Pharmacovigilance guidelines for clinical application of Chinese patent medicines for mucosal administration

作　　者：赵晓晓 华红[3] 黎元元[1] 王志飞[1] 刘福梅[1] 魏瑞丽[1] 崔鑫 杨硕 王连心[1] 谢雁鸣[1] ZHAO Xiao-xiao;HUA Hong;LI Yuan-yuan;WANG Zhi-fei;LIU Fu-mei;WEI Rui-li;CUI Xin;YANG Shuo;WANG Lian-xin;XIE Yan-ming(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Bejing 100700,China;Graduate School,Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China;School and Hospital of Stomatology,Peking University,Beijing 100034,China)

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700 [2]天津中医药大学研究生院,天津301617 [3]北京大学口腔医院,北京100034

出　　处：《中国中药杂志》2024年第16期4291-4297,共7页China Journal of Chinese Materia Medica

基　　金：国家重点研发计划项目(2018YFC1707400,2022YFC3502004);中央级公益性科研院所基本科研业务费专项(Z0737)。

摘　　要：由中国中医科学院中医临床基础医学研究所与北京大学口腔医院牵头,中华中医药学会归口管理的《黏膜给药中成药临床应用药物警戒指南》团体标准于2024年1月16日在全国团体标准信息平台公布,标准号T/CACM 1563.6-2024。旨在依据《中华人民共和国药品管理法》(2019年修订版),提出关键要素,指明安全性监测与报告、信号识别、风险评估、风险控制的技术方法,主要针对黏膜给药中成药临床应用药物警戒内容建立规范性的符合中药特点的黏膜给药中成药药物警戒指南。该团体标准经过组内外专家多轮征求意见,最终形成了适用于药品上市许可持有人、药品生产企业、医疗机构、科研院所、药品经营企业药物警戒相关从业人员进行药物警戒活动的指南性文件。The group standard Pharmacovigilance guidelines for clinical application of Chinese patent medicines for mucosal administration was released on January 16,2024,on the national group standards information platform by the Institute of Basic Research in Clinical Medicine of China Academy of Chinese Medical Sciences and School and Hospital of Stomatology of Peking University,under the centralized management by the China Association of Chinese Medicine.The standard number is T/CACM 1563.6-2024.It aims to propose key elements and specify technical methods for safety monitoring and reporting,signal identification,risk assessment,and risk control based on the Drug administration law of the People's Republic of China(revised in 2019),which establishes normative pharmacovigilance guideline of Chinese patent medicine for mucosal administration that is in line with the characteristics of traditional Chinese Medicine(TCM)based on the pharmacovigilance content for clinical application of Chinese patent medicine for mucosal administration.The group standard has been discussed by internal and external experts through multiple rounds of consultation.It serves as a guiding document for stakeholders involved in pharmacovigilance activities,including pharmaceutical license holders,drug manufacturers,medical institutions,research institutes,and pharmaceutical trading enterprises.

关 键 词：黏膜给药中成药 药物警戒 指南 中医药 团体标准 

分 类 号：R288[医药卫生—中药学]