摘要
目的:回顾国家药品标准物质标签管理的发展历程,探讨完善国家药品标准物质标签管理的方法。方法:梳理国家药品标准物质标签管理的发展历程,剖析现存问题,结合国际经验与技术趋势,提出科学化与智能化并行的管理策略。结果与结论:国家药品标准物质标签管理历经30余年的发展,通过完善技术审核体系、优化生产工艺、强化稳定性研究等举措,实现了从1956年3个品种至2024年5000余种品类的跨越式发展。但仍存在标签内容与形式、打印设备与技术、信息化管理体系等问题。通过优化标签内容与形式、引入无线射频识别技术、借鉴国际先进经验和标准等措施,实现标签管理从规范化向智能化的跃迁。药品标准物质标签管理是保障药品质量安全的重要环节,应持续推进科学化、智能化、国际化管理,为筑牢药品质量安全防线提供坚实有力的支持。
Objective:To review the development of national drug standard material label management and explore ways for improvement.Methods:The development of national drug standard material label management was reviewed,existing problems were analyzed,and a scientific and intelligent management strategy was proposed based on international experiences and technology trends.Results and Conclusion:After more than three decades of development,national drug standard material label management has achieved a leapfrog development from 3 varieties in 1956 to more than 5000 varieties in 2024 through improving the technical review system,optimizing the production process,and strengthening stability research.However,there are still problems such as label contents and forms,printing equipment and technologies,and information management system.By optimizing label contents and forms,introducing RFID technology,and drawing on international advanced experiences and standards,the transition of label management from standardization to intelligence is achieved.Drug standard material label management is an important part of ensuring drug quality and safety.Scientific,intelligent,and international management should be continuously promoted to provide solid and strong support for building a solid line of defense for drug quality and safety.
作者
王雅君
尹慧东
刘换平
刘明理
Wang Yajun;Yin Huidong;Liu Huanping;Liu Mingli(National Institutes for Food and Drug Control,Beijing 102629,China)
出处
《中国药事》
2025年第5期545-551,共7页
Chinese Pharmaceutical Affairs
关键词
国家药品标准物质
标签
管理
发展历程
展望
national drug standard materials
label
management
development history
prospect
作者简介
王雅君,Tel:(010)53852516,E-mail:wangyajun@nifdc.org.cn;通信作者:刘明理,Tel:(010)53852510,E-mail:lml@nifdc.org.cn。
