药品供应链安全框架下的国内外药品追溯体系研究-中国药事.PDF

中国药事 2017年11月 第31卷 第11期 1263 药品供应链安全框架下的国内外药品追溯体系研究 * 沈静远，梁毅 （中国药科大学国际医药商学院，南京 211198） 摘要 目的： 从监管部门的角度，研究比较了典型国家和地区药品追溯体系的建立情况，为完善我国药 品追溯体系提供参考意见。方法：选择美国、欧盟以及土耳其这 3 个具有代表性的药品追溯体系进行分 析，对我国的基本情况进行研究对比。结果与结论：随着经济全球化的发展，药品供应链越来越复杂， 供应链的安全问题日趋凸显。建议我国引入药品信息档案和唯一识别标识码，鼓励企业建立物流信息管 理系统；建立国家药品流通信息数据库，逐步健全以保障患者用药安全为宗旨的药品追溯体系。 关键词： 药品供应链；追溯体系；药品追踪和跟踪；药品质量安全管理；电子监管码 R95 A 1002-7777(2017)11-1263-07 中图分类号： 文献标识码： 文章编号： doi:10.16153/j.1002-7777.2017.11.007 On Drug Tracing System at Home and Abroad under the Security Framework of Drug Supply Chain * Shen Jingyuan, Liang Yi (School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing 211198, China) Abstract Objective: To compare the establishment of drug tracing systems in different countries and regions from the perspective of regulatory authorities in order to provide references for improving drug tracing system in China. Methods: Three representative drug tracing systems of US, EU, and Turkey were selected and compared with the basic situation of those in China. Results and Conclusion: With the development of economic globalization, drug supply chain has been more and more complex and the security issues of the supply chain have become increasingly prominent. It was suggested that drug information files and unique identification codes should be introduced in China, logistics information management system should be established in the enterprises, a national drug distribution information database should be established and a drug tracing system should be improved step by step with the purpose of ensuring the medication safety of patients. Keywords ： drug supply chain; drug tracing system; drug tracking and tracing; drug quality and safety management; electronic monitoring code 1 概述