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放眼国际,早在20世纪90年代,部分发达国家和地区已开始探索和建立追溯制度来推进药品质量安全管理。美国、欧盟是较早开展药品追溯标准化工作的国家和地区,其已建立的法律法规体系和配套执行机构较为完善。这种以预防、控制和追溯为特征的药品质量安全追溯监管体系,可使药品在生产、流通、使用等环节受到全程监控,值得我国在完善药品追溯体系的过程中加以借鉴。美国的一物一码追溯系统
Looking to the world, as early as the 1990s, some developed countries and regions started to explore and establish a retrospective system to promote drug quality and safety management. The United States and the European Union are the countries and regions that started the drug traceability standardization earlier. The established laws and regulations system and the supporting implementing agencies are perfect. This kind of drug quality and safety traceability supervision system characterized by prevention, control and tracing can make the medicine be monitored in the process of production, circulation and use, which is worth our reference in the process of perfecting the medicine traceability system. America’s one-object tracking system