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日本药品稳定供应制度对提升我国短缺药供应保障能力的政策启示
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| 篇名： | 日本药品稳定供应制度对提升我国短缺药供应保障能力的政策启示 |
| TITLE： | Japan’s stable supply system for pharmaceuticals：its inspiration for enhancing the supply assurance capability of drugs in shortage in China |
| 摘要： | 目的 为提升我国短缺药供应保障能力提供思路。方法通过梳理日本药品稳定供应制度的顶层设计思路，详细介绍日本现行的药品稳定供应政策内容，并结合我国短缺药供应保障的现存问题提出政策建议。结果与结论日本为了保障药品稳定供应，制定了贯穿“事前预防措施、早期风险监测、发生供应问题时的应对机制”三阶段的政策框架体系。事前预防措施包括建立药品稳定保供清单分级分类制度、掌握易断供药品的制造程序和流程、建立药品持续供应和停产报告制度；早期风险监测包括建立企业供应风险自查评估制度、公开企业供应保障信息、制定价格保护与激励措施；发生供应问题时的应对机制包括建立企业增产和协调供货机制、建立原料药变更快速审评审批制度、建立紧急强制调货供应制度。建议我国从细化短缺药遴选标准、加强信息公开流转、优化价格管理手段、明确问题反馈与处理4个方面，精细化短缺药激励与监管政策，兼顾短缺药“保供应”和“强监管”。 |
| ABSTRACT： | OBJECTIVE To provide insights for enhancing the supply assurance capability of drugs in shortage in China. METHODS By sorting out top-level design ideas for Japan’s stable supply system for pharmaceuticals， this study elaborates on its current policies for stabilizing drug supply. Policy suggestions were proposed for existing challenges in the supply of drugs in shortage in China. RESULTS & CONCLUSIONS To stabilize drug supply， Japan formulated a systematic 3-tier policy framework that ran through pre-prevention， early risk monitoring， and response mechanisms for supply problems. Pre-prevention measures included establishing a graded classification system for stable supply lists， strengthening government control over the drug production process， and implementing a continuous supply system and cessation reporting system for post-market drugs. Early risk monitoring included self-assessing risks in enterprises， disclosing information concerning supply assurance of enterprises， and providing enterprises with price protection and incentives measures. Response mechanisms for supply problems included establishing the mechanism of increasing production and coordinated supply in enterprises， opening fast-track review and approval channels for changes in raw materials， and establishing emergency systems of transferring drugs to supply. To balance supply assurance and strong regulation of drugs in shortage through refining the incentive and regulatory policies for them， it is recommended to refine the criteria for selecting drugs in shortage， strengthen the circulation of information， optimize price management methods， and clarify problem feedback and solving. |
| 期刊： | 2024年第35卷第10期 |
| 作者： | 王琳宁；顾灵娜；虞杰；路云 |
| AUTHORS： | WANG Linning，GU Lingna，YU Jie，LU Yun |
| 关键字： | 短缺药；药品供应；价格管理；应对机制 |
| KEYWORDS： | drug in shortage； drug supply； price regulation； coping mechanism |
| 阅读数： | 20 次 |
| 本月下载数： | 1 次 |
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