【摘要】 文章系统分析了我国药品集中采购的政策背景、组织与管理、程序与方法、质量管理以及监督管理等方面的内容。自2018年国家医保局成立以来，我国药品集中采购工作逐步从试点走向制度化，通过“国家组织、联盟采购、平台运作”的模式，推动药品价格合理回归，减轻患者负担，促进医药行业的高质量发展。文章详细探讨了药品集中采购的组织架构、职责分工、工作制度与流程，以及采购计划、公告发布、企业资质审核、药品评价与遴选、入围企业与产品确定、结果公示与申诉处理等关键环节；同时强调了质量管理和监督管理的重要性，提出了加强中选企业质量监管、建立质量追溯与监测机制、完善监督制度与多重复核制度、强化采购各环节监督、处理投诉与举报等具体措施。通过这些措施，药品集中采购工作将更加规范、高效，为我国医药行业的健康发展提供有力保障。更多还原

【Abstract】 This article systematically analyzes the policy background, organization and management, procedures and methods, quality management, and supervision and management of centralized drug procurement in China. Since the establishment of the National Healthcare Security Administration in 2018, China’s centralized drug procurement work has gradually moved from pilot to institutionalized. Through the model of "national organization, alliance procurement, and platform operation", it has promoted the reasonable return of drug prices, reduced the burden on patients, and facilitated the high-quality development of the pharmaceutical industry. The article elaborates in detail on the organizational structure, division of responsibilities, working systems and processes of centralized drug procurement, as well as key links such as procurement plans, announcement release, enterprise qualification review, drug evaluation and selection, determination of shortlisted enterprises and products, result public announcement and complaint handling. At the same time, it emphasized the significance of quality management and supervision and management, and proposed specific measures such as strengthening the quality supervision of the selected enterprises, establishing a quality traceability and monitoring mechanism, improving the supervision system and multiple review system, intensifying supervision at each link of procurement, and handling complaints and reports. Through these measures, the centralized procurement of drugs will become more standardized and efficient, providing a strong guarantee for the healthy development of China’s pharmaceutical industry.更多还原