Wang Lian-Xin, Wang Meng-Meng, Li Yuan-Yuan, Wang Zhi-Fei, Cui Xin, Zhao Xiao-Xiao, Liu Fu-Mei, Yang Shuo, Wei Rui-Li, Wang Ya-Xing, Zhang Bing, Xie Yan-Ming
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China.
Beijing University of Chinese Medicine Beijing 100029, China.
Zhongguo Zhong Yao Za Zhi. 2024 Aug;49(16):4261-4265. doi: 10.19540/j.cnki.cjcmm.20240623.501.
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.
《中华人民共和国药品管理法（2019年修订版）》于2019年12月1日起施行，提出“国家建立药物警戒制度”。中成药的药物警戒工作难度较大，有必要开展符合中成药特点的药物警戒活动。《中成药药物警戒指南（T/CACM 1563.1-2024）》依据《中华人民共和国药品管理法（2019年修订版）》和国家药品监督管理局《药物警戒质量管理规范（2021年第65号）》的原则，借鉴欧盟药物警戒法规及人用药品注册技术要求国际协调理事会（ICH）二级指南，并根据《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，结合中成药特点编制而成。它作为中成药一系列药物警戒指南的通用文件，如《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）》、《黏膜用中成药临床应用药物警戒指南（T/CACM 1563.6-2024）》，包含中成药药物警戒监测与报告、信号识别、风险评估、风险控制四大要素以及中成药药物警戒活动，保障公众用药安全。
