中成药说明书安全性信息项修订的探讨与思考

Revision of safety information in instructions of traditional Chinese patent medicines and simple preparations

目的对中成药说明书安全性信息项如何修订进行探讨与思考。方法参照《已上市中药说明书安全信息项内容修订技术指导原则(试行)》(2022年第1号),通过分析中成药说明书中【禁忌】【不良反应】【注意事项】【特殊人群用药】及警示语内容,结合中成药说明书安全性信息项修订的实践经验提出相关思考。结果与结论药品上市许可持有人(简称“持有人”)可从补充安全性信息缺失项内容、规范相关术语、正确标注安全性信息方面对说明书安全性信息项进行完善。在具体修订过程中持有人应通过多个渠道对安全性信息进行全面、系统的检索,将检索到的信息整理、分析,形成证据条目并将其作为修订依据,依据修订依据对中成药说明书安全性信息项进行修订,从而为临床使用中成药提供更加科学准确的指导信息。

Objective To study how to revise the safety information items in instructions for traditional Chinese patent medicines and simple preparations.Methods With reference to the Technical Guidelines for the Revision of Safety Information Items in the Instructions of Listed Traditional Chinese Medicine(Trial)(No.1 in 2022),this paper analyzed the contents of such warnings as“taboos”,“adverse reactions”,“precautions”and“medications for special groups”in the instructions for traditional Chinese patent medicines and simple preparations,and offered recommendations in combination with the practical experience associated with the revision of safety information items in these instructions.Results and Conclusion Marketing authorization holders can improve the safety information items in the instructions by supplementing the missing items,standardizing related terminology,and correctly labeling safety information.During the process of revision,marketing authorization holders are to conduct exhaustive search of safety information by different means,and sort out and analyze the retrieved information as items of evidence that underlie any revision.The safety information items in the instructions for traditional Chinese patent medicines and simple preparations should be revised on this basis so as to provide more accurate guidance for clinical use of traditional Chinese patent medicines and simple preparations.