关于药品追溯码的探析

Analysis and Discussion on the Drug Traceability Codes

目的:研究药品追溯码编码要求,探讨选择合规的药品追溯码应重点考虑的问题,为药品企业赋码工作提供参考。方法:结合国家药品监督管理局已发布标准的内容,阐述了药品追溯码基本概念和要求,分析了我国药品追溯码现状,研究提出选择药品追溯码应重点考虑的问题。结果与结论:药品追溯码用于唯一标识药品销售包装单元,是实现药品追溯的关键基础,药品上市许可持有人和生产企业应当根据相关政策文件和标准规范要求,同时考虑国内基础和国际惯例,兼顾市场需求和自身实际,选择和使用符合标准的药品追溯码。

Objective: To study the coding requirements of drug traceability codes and discuss the key issues that should be considered in the selection of compliant drug traceability codes, so as to provide references for the coding work of pharmaceutical enterprises. Methods: Based on the standards released by National Medical Products Administration, the basic concepts and requirements of drug traceability codes were elaborated, the status quo of drug traceability codes in China was analyzed, and issues that should be considered when selecting drug traceability codes were studied. Results and Conclusion: The drug traceability codes are used to uniquely identify the packaging unit for drug sales. They are the key basis for drug traceability. Drug marketing authorization holders and manufacturers should select and use standard drug traceability codes that meet the requirements of the relevant policies and regulations, while considering domestic basis and international practices and taking into account market needs and their own realities.