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.
Zhongguo Zhong Yao Za Zhi. 2022 Jan;47(2):285-294. doi: 10.19540/j.cnki.cjcmm.20211117.501.
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".
药品说明书作为记录药品有效性和安全性信息的法定技术文件，是指导医生、药师和患者合理用药的重要依据，其科学性、规范性和准确性直接影响公众用药安全。药品说明书中的药品不良事件、禁忌、注意事项、警示以及特殊人群用药等内容直接体现了用药安全信息和合理用药措施。在药品生命周期中，药品上市许可持有人（MAHs）需要及时更新说明书中的安全信息，以确保临床用药的安全性和有效性。目前，修订说明书是控制药品风险的重要举措。在药品生命周期中，为规范药品上市许可持有人对说明书安全信息的修订，消除“不清楚”等表述不确切的用语，在中国中药协会标准化部门指导下，制定了《中药上市后说明书安全信息变更技术规范》等一系列团体标准。因此，在现有法律法规基础上，形成了规范的说明书修订技术程序，以助力临床安全合理用药，落实“健康中国”战略。
