《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  

Series of group standards of Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions

作　　者：张冰[1,2] 张晓朦 林志健[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 Bing;ZHANG Xiao-meng;LIN Zhi-jian;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285-294,共10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：药品说明书是载明药品重要信息的法定文件,是表达药物有效性与安全性的重要技术资料。其作为指导医生、药师和患者合理用药的重要依据,科学、规范、准确的表述直接关系到公众的用药安全。药品说明书安全信息项目是指能够直接反映药品的安全性与合理用药措施的相关项目,包括【不良反应】、【禁忌】、【注意事项】、特殊人群用药以及警示语。在产品全生命周期内,药品上市许可持有人(MAHs)都需及时补充、更新中成药说明书安全信息,以保证药品临床使用的安全有效,保障患者的用药安全。目前,中成药说明书中安全信息项目中存在"尚不明确"、更新不及时、表述不准确等问题,影响了中成药的安全合理应用,亟待开展修订。为帮助MAHs全面、规范地修订说明书安全信息项目,由中华中医药学会标准化办公室立项,北京中医药大学中药药物警戒与合理用药研究中心以说明书相关管理规范为依据,建立了《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,形成说明书修订的标准化技术流程,为控制药品使用风险、保障用药安全提供依据。Drug instructions,the statutory and technical documents recording effectiveness and safety information,are an important basis for guiding doctors,pharmacists,and patients to use drugs rationally,and their scientificity,standardization,and accuracy directly affect the medication safety of the public.The sections of adverse drug events,contraindications,precautions,warnings,and application for specific populations in drug instructions directly express safety information and measures for rational use of drugs.In the drug life cycle,marketing authorization holders(MAHs)need to update safety information in the instructions promptly to ensure the safety and effectiveness of clinical drug medication.At present,revising instructions is an important measure to control drug risks.In the drug life cycle,in order to standardize the revision of safety information in the instructions by MAHs and eliminate inexact terms such as"unclear",the Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions,a series of group standards,have been established under the guidance of Standardization Department,China Association of Chinese Medicine.Therefore,on the basis of the existing rules and regulations,the standardized technical procedures for revising instructions came into being to help clinical safe and rational medication of drugs,and implement the strategy of"Healthy China".

关 键 词：中成药说明书 安全信息项目 修订 技术规范 团体标准 

分 类 号：R288[医药卫生—中药学]