《上市中成药说明书安全信息项目修订技术规范》系列团体标准解读  

Interpretation of Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions

作　　者：张晓朦[1,2] 林志健 张冰[1,2] 萨日娜 吕锦涛[1,2] 吴昊 李耀磊 徐慧哲 黄政凯[1,2] 郭宇博 苏祥飞 段笑娇 ZHANG Xiao-meng;LIN Zhi-jian;ZHANG Bing;SA Ri-na;LYU Jin-tao;WU Hao;LI Yao-lei;XU Hui-zhe;HUANG Zheng-kai;GUO Yu-bo;SU Xiang-fei;DUAN Xiao-jiao(School of Chinese Materia Medica,Beijing University of Chinese Medicine,Beijing 102488,China;Research Center for Pharmacovigilance and Rational Use of Traditional Chinese Medicine,Beijing University of Chinese Medicine,Beijing 102488,China;National Museum of Traditional Chinese Medicine,Beijing 100027,China;Standardization Office of Chinese Association of Chinese Medicine,Beijing 100029,China)

机构地区：[1]北京中医药大学中药学院,北京102488 [2]北京中医药大学中药药物警戒与合理用药研究中心,北京102488 [3]国家中医药博物馆,北京100027 [4]中华中医药学会标准化办公室,北京100029

出　　处：《中国中药杂志》2022年第2期295-300,共6页China Journal of Chinese Materia Medica

基　　金：国家中医药领军人才支持计划“岐黄学者”项目;第三批国家高层次人才特殊支持计划(万人计划)教学名师项目;国家自然科学基金项目(81874349)。

摘　　要：由北京中医药大学中药药物警戒与合理用药研究中心牵头,中华中医药学会归口管理的《上市中成药说明书安全信息项目修订技术规范》系列团体标准于2021年7月23日正式发布,7月31日起实施。该系列团体标准包括6项,分别是《通则》《不良反应》《禁忌》《注意事项》《特殊人群用药》《警示语》。其中《通则》为纲领性技术规范,阐释中成药说明书修订的一般技术要求;《不良反应》《禁忌》《注意事项》《特殊人群用药》《警示语》分别切入具体项目从信息的收集、筛选、转化到示例表述,形成标准化的修订技术流程。该系列标准的制定经过多轮调研,汇聚"医-药-管-法-企"不同专业领域200余位专家建议,形成共识,旨在建立上市中成药说明书安全信息项目修订的标准化技术流程,指导药品上市许可持有人(MAHs)修订说明书实操,推动药学服务与学术发展,促进临床安全合理使用中成药,具有突出的现实意义。Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions,a series of group standards,were proposed by Professor ZHANG Bing from Research Center for Pharmacovigilance and Rational Use of Traditional Chinese Medicine,and underwent centralized management by Chinese Association of Chinese Medicine.They were officially released on July 23 and implemented on July 31,2021.The series of group standards consist of six sections,including general principles,adverse drug events,contraindications,precautions,application for special populations,and warnings.The section of general principles is comprised of holistic and programmatic expressions,which explain the general technical requirements for revising the marketed Chinese patent medicine instructions.The other five sections focus on information collection,screening,transformation,and illustration of specific items,forming a standardized revision technical process.This series of standards is the result of multiple rounds of research and the suggestions of more than 200 experts in different professional fields of"medicine-pharmacy-management-law-enterprise"have been gathered therein to reach a consensus.With the purposes of establishing standardized technical specifications for the revision of safety information in the marketed Chinese patent medicine instructions,guiding marketing authorization holders in revising the instructions,filling the gaps in the research of Chinese patent medicine instructions,promoting the deve-lopment of pharmaceutical care and academic research,and encouraging the rational and safe medication of Chinese patent medicine,the series of group standards is of great significance.

关 键 词：团体标准 中成药说明书 安全信息 修订 技术规范 

分 类 号：R288[医药卫生—中药学]