我国药品追溯体系建设的思考

On the Construction of Drug Traceability System in China

目的:研究在当前环境下如何构建满足行业需求和监管要求的药品追溯体系,为指导相关方在统一框架下建设药品追溯体系提供参考,以期实现药品追踪溯源的目标。方法:结合当前药品追溯体系建设现状和实际需求,从政策法规要求、技术条件变化、国际借鉴经验和重点关注问题等方面进行探讨和分析,提出新时期我国药品追溯体系建设推进策略。结果与结论:综合考虑当前药品追溯工作现状,提出药品追溯体系建设应当采取政府引导、企业为主、第三方参与、全社会共建共享的模式:国家组织制定统一标准规范,建设药品追溯协同服务平台,串联企业自建和第三方追溯系统的信息,辅助追溯系统最终形成完整的追溯数据链条;企业依法承担追溯主体责任,建立健全药品追溯系统,根据标准,采集、存储及上传企业和药品基本信息以及流向等追溯信息;共同推动实现药品生产、流通和使用全过程来源可查、去向可追、责任可究。

Objective:To study how to build a drug traceability system that meets the need of industrial and regulation in the current situation,and to provide a reference for the construction of a drug traceability system under the unified framework,so as to achieve the goal of drug traceability.Methods:Based on the current situation and actual needs of drug traceability system construction,it discussed and analyzed the requirements of policies and regulations,changes of technical conditions,international experience and key issues,and proposes strategies of promoting the construction of China’s drug traceability system in the new period.Results and Conclusion:Comprehensively considering the current status of drug traceability,it is proposed that the drug traceability system should adopt the model of government guidance,enterprise-oriented,third party participation,and social co-construction and sharing:national organizations should formulate unified standards and norms,build a drug traceability harmonization service platform,link the information of the company’s self-built and third-party traceability systems to help the traceability system eventually form a complete traceability data chain;enterprises should implement the responsibility of traceability in accordance with the law,establish and improve the drug traceability system,collect,store and upload traceability information of enterprise and drug essential information as well as distribution information,which will jointly promote the realization of the whole process of drug production,circulation and use,thus the sources of drug use can be traced,the distribution can be followed and the responsibility can be investigated as soon as possible.