| 郗昊,朱炯,王翀.日本仿制药上市后质量抽检模式研究与启示[J].中国药事,2021,35(8):923-931 |
| 日本仿制药上市后质量抽检模式研究与启示 |
| Research on Postmark Sampling and Testing Model of Generic Drugs in Japan and Its Enlightenment |
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| DOI：10.16153/j.1002-7777.2021.08.011 |
| 中文关键词: 仿制药 质量抽检 风险防控 |
| 英文关键词: generic drugs sampling and testing risk control |
| 基金项目: |
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| 摘要点击次数: 600 |
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| 中文摘要: |
| 目的：为完善我国国家药品抽检机制，探索仿制药品质量安全风险防控模式提供参考。方法：采用文献研究的方法，汇总、分析日本仿制药抽检的相关法律法规文件、关键管理措施和已公布的年度报告(2008-2019年)等信息。结果：日本构建了以仿制药信息研讨会为核心的组织管理体系、基于风险综合研判的品种遴选模式、统一协作的抽样检验网络、围绕仿制药全领域的质量研判构架。结论：日本仿制药抽检作为“仿制药品质再评价工程”的有效延伸，体系较为完备、计划性较好，形成了以研讨会为核心的风险防控工作模式。参考日本经验，建议我国建立仿制药一致性评价与专项抽检沟通机制，稳步增加仿制药相关领域专家数量，设立抽检品种档案，对难以抽到的产品进行综合研判。 |
| 英文摘要: |
| Objective: To provide references for improving the national drug sampling mechanism and exploring the quality and safety risk prevention and control model of generic drugs. Methods: Literature research was used to summarize and analyze the relevant laws and regulations, key management measures, and published annual reports (2008-2019) on sample testing of generic drugs in Japan. Results: Japan has established an organizational management system with generic drug information seminars as the core, a variety selection model based on risk comprehensive research and judgment, a unified and cooperative sampling and inspection network, and a quality research and judgment framework centering on the whole field of generic drugs, and a quality evaluation framework centering on the whole area of generic drugs. Conclusion: As the efficacious extension of the “Generic Drug Quality Revaluation Project”, with a complete system and proper schedule, sampling and testing program of Japanese generic drugs has a relatively complete system and good planning and has established a risk prevention and control work mode with the seminar as the core. Referring to the experience of Japan, it is suggested that China establish a communication mechanism for consistency evaluation and sampling and special sampling and testing system, steadily increase the number of experts in the field of generic drugs, set up sampling inspection variety files, and conduct comprehensive research and judgment on the samples that are seldom sampled. |
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