• 中国核心期刊(遴选)数据库收录期刊
  • 中文科技期刊数据库收录期刊
  • 中国期刊全文数据库收录期刊
  • 中国学术期刊综合评价数据库统计源期刊等

中国药物评价 ›› 2019, Vol. 36 ›› Issue (6): 460-463.

• 管理研究 • 上一篇    下一篇

我国仿制药一致性评价工作进展研究

王敏1,冀英辰1,刘静霞1,李坤2,谢紫薇1,郭梦语3,赵聪1, 廉洁1,武治印1,李青4   

  1. 1. 国家卫生健康委医药卫生科技发展研究中心
    2. 中国医药生物技术协会
    3. 国药集团工业有限公司
    4. 中国医学科学院
  • 收稿日期:2020-01-19 出版日期:2019-12-28 发布日期:2020-01-21
  • 基金资助:
    天津滨海新区科技创新发展战略研究计划项目

Research on Progress of Generic Drug Consistency Evaluation in China

  • Received:2020-01-19 Online:2019-12-28 Published:2020-01-21
  • Supported by:
    全球视野下滨海新区生物医药产业创新发展对策研究

摘要: 目的: 通过研究仿制药质量和疗效一致性评价药品基本情况、联动机制的实施情况、相关激励政策落实情况等方面的进展,了解我国仿制药一致性评价现状,为促进我国仿制药质量提升提出建议。方法:将289目录按照《国家基本药物目录》进行分类,通过查询《中国上市药品目录集》将查询结果分别与2012版和2018版《国家基本药物目录》进行对比,查询相关网站政策落实公告,对仿制药一致性评价工作进行全面分析。结果:我国仿制药质量和疗效一致性评价工作任务虽尚未完成,但已取得很大进展。结论:加大力度推动一致性评价工作深入开展,在调整产业机构,保障国家药品安全有效方面有重大意义。

Abstract: Objective:In order to understand the status of generic drug consistency evaluation and provide advice for promoting the quality improvement of generic drugs in China, the consistency of the quality and efficacy of generic drugs, the evaluation results of the progress of the basic situation of the drug, and the implementation of the linkage mechanism and relevant incentive policies were studied. Methods:The 289 catalogue was classified according to the "National Essential Drugs List". The query results were compared with the 2012 edition and the 2018 edition of the National Essential Drugs List by querying the "China Listed Drugs List", and the relevant website policy implementation announcements were inquired. A comprehensive analysis of generic drug conformity assessment work. Results:Although the task of evaluating the consistency and quality of generic drugs in China has not been completed, great progress has been made. Conclusion:It is of great significance to intensify efforts to promote the consistency evaluation work in depth and to adjust industrial institutions to ensure the effectiveness of national drug safety.

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