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.
Zhongguo Zhong Yao Za Zhi. 2022 Jan;47(2):295-300. doi: 10.19540/j.cnki.cjcmm.20211117.502.
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.
《已上市中成药说明书安全信息修订技术规范》系列团体标准由中药不良反应与合理用药研究中心的张冰教授提出，由中国中药协会归口管理。于2021年7月23日正式发布，7月31日起实施。该系列团体标准共包括6个部分，分别为总则、药品不良反应、禁忌、注意事项、特殊人群用药、警示。其中，总则部分为整体性、纲领性表述，阐述了已上市中成药说明书修订的总体技术要求；其他5个部分聚焦于具体项目的信息收集、筛选、转化及表述，形成了规范的修订技术流程。该系列标准经过多轮研究，广泛征求了“医-药-管-法-企”等200余名不同专业领域专家的意见并达成共识。该系列团体标准旨在建立已上市中成药说明书安全信息修订的标准化技术规范，指导上市许可持有人修订说明书，填补中成药说明书研究空白，促进药学服务与学术研究发展，推动中成药合理安全用药，具有重要意义。
