中成药药物警戒指南

Pharmacovigilance guidelines of Chinese patent medicines

2019年12月1日开始实施的《中华人民共和国药品管理法》(2019年修订版)提出“国家建立药物警戒制度”。中成药药物警戒工作更具难点,因此建立符合中成药特点的药物警戒活动非常必要。《中成药药物警戒指南》(T/CACM 1563.1-2024)在遵循《中华人民共和国药品管理法》(2019年修订版)、国家药品监督管理局《药物警戒质量管理规范》(2021年第65号)原则基础上,借鉴欧盟《药物警戒法规》、国际人用药品注册技术协调会(ICH)的二级指导原则,结合中成药自身特点,按照《标准化工作导则·第1部分·标准化文件的结构和起草规则》(GB/T 1.1-2020)的规定起草,为《医疗机构中药药物警戒体系建设指南》(T/CACM 1563.2-2024)、《口服中成药临床应用药物警戒指南》(T/CACM 1563.3-2024)、《中药注射剂临床应用药物警戒指南》(T/CACM 1563.4-2024)、《外用中成药临床应用药物警戒指南》(T/CACM 1563.5-2024)、《黏膜给药中成药临床应用药物警戒指南》(T/CACM 1563.6-2024)等系列中成药药物警戒指南的总则性文件,包括中成药药物警戒的监测与报告、信号识别、风险评估、风险控制等4个环节,以及中成药药物警戒活动,保障了公众用药安全。

Drug administration law of the People's Republic of China(2019 revised edition),which came into effect on December 1,2019,proposed that"the state shall establish a pharmacovigilance system".Pharmacovigilance work of Chinese patent medicines is more difficult,and it is necessary to carry out Pharmacovigilance activities that are in line with the characteristics of Chinese patent medicines.Pharmacovigilance guidelines of Chinese patent medicines(T/CACM 1563.1-2024),based on the principles of Drug Administration Law of the People's Republic of China(2019 revised edition)and Pharmacovigilance quality management standards(No.65 of 2021)of the National Medical Products Administration,draws on the EU Pharmacovigilance regulation and the secondary guidelines of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use(ICH),and it is drafted in accordance with the provisions of Guidelines for standardization work part 1:structure and drafting rules of standardization documents(GB/T1.1-2020)based on the characteristics of Chinese patent medicines.It serves as a general document for a series of pharmacovigilance guidelines of Chinese patent medicines,such as Guidelines for construction of traditional Chinese medicine pharmacovigilance system in medical institutions(T/CACM 1563.2-2024),Pharmacovigilance guidelines for clinical application of oral Chinese patent medicines(T/CACM 1563.3-2024),Pharmacovigilance guidelines for clinical application of traditional Chinese medicine injections(T/CACM 1563.4-2024),Pharmacovigilance guidelines for clinical application of Chinese patent medicines for external use(T/CACM 1563.5-2024),and Pharmacovigilance guidelines for clinical application of Chinese patent medicines for mucosal administration(T/CACM 1563.6-2024),including four major elements of pharmacovigilance monitoring and reporting of Chinese patent medicines,signal identification,risk evaluation,and risk control,as well as pharmacovigilance activities for Chinese patent medicines,ensuring the safety of public drug use.