Liu Fu-Mei, Zhang Li, Li Yuan-Yuan, Wang Zhi-Fei, Zhao Xiao-Xiao, Cui Xin, Wei Rui-Li, Yang Shuo, Wang Lian-Xin, Xie Yan-Ming
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China.
Dongfang Hospital of Beijing University of Chinese Medicine Beijing 100700, China.
Zhongguo Zhong Yao Za Zhi. 2024 Aug;49(16):4266-4272. doi: 10.19540/j.cnki.cjcmm.20240509.501.
The group standard Guidelines for construction of traditional Chinese medicine(TCM) pharmacovigilance system in medical institutions, managed by Chinese Association of Chinese Medicine and led by the Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences and Dongfang Hospital of Beijing University of Chinese Medicine, was announced on National Group Standard Information Platform on January 16, 2024, with the standard number T/CACM 1563. 2-2024. According to EU pharmacovigilance regulations and the second-level guidance principles of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use(ICH), the unique characteristics of TCM were fully considered, and the relevant systems and procedures for constructing TCM pharmacovigilance systems in medical institutions were clearly defined. This included establishing TCM pharmacovigilance information platforms, arranging staff, formulating various regulations, and monitoring adverse reactions of TCM(including TCM decoction pieces, granules, Chinese patent medicines, in-hospital preparations, and pre-marketed Chinese patent medicines). It aimed to develop a TCM pharmacovigilance system in medical institutions that was tailored to the characteristics of TCM. The system could be appropriately adjusted according to the scope of practice and actual circumstances of medical institutions at different levels. This will enhance the implementation of TCM pharmacovigilance work and safeguard medication safety. The group standard underwent multiple rounds of consultations with internal and external experts and has ultimately evolved into a guiding document applicable to medical institutions and related entities engaged in pharmacovigilance activities.
由中华中医药学会归口，中国中医科学院中医药临床基础医学研究所、北京中医药大学东方医院牵头制定的团体标准《医疗机构中药药物警戒系统建设指南》于2024年1月16日在国家团体标准信息平台发布，标准编号为T/CACM 1563. 2-2024。该标准充分考虑了中药的独特性，依据欧盟药物警戒法规及国际人用药品注册技术协调会（ICH）二级指导原则，明确了医疗机构中药药物警戒系统建设的相关制度与程序，包括建立中药药物警戒信息平台、人员配备、制定各项规章制度以及监测中药（包括中药饮片、颗粒剂、中成药、院内制剂、上市前中成药）不良反应等，旨在构建适合中药特点的医疗机构中药药物警戒系统，该系统可根据不同级别医疗机构的业务范围和实际情况进行适当调整，这将加强中药药物警戒工作的落实，保障用药安全。该团体标准经过多轮内外专家咨询，最终形成了适用于医疗机构及从事药物警戒活动相关单位的指导性文件。
