中国药物警戒 ›› 2017, Vol. 14 ›› Issue (9): 527-529.

• 药品上市后监测与评价专栏 • 上一篇    下一篇

日本药品上市后评价制度对我国的启示

田春华1, 李馨龄1, 周冉2, 薛斌2, 杨威1*   

  1. 1 国家食品药品监督管理总局药品评价中心,北京100045;
    2 中国食品药品国际交流中心,北京100082
  • 收稿日期:2017-11-06 修回日期:2017-11-06 出版日期:2017-09-20 发布日期:2017-11-06
  • 通讯作者: 杨威,男,本科,药学,药品上市后监测与评价。E-mail：yangwei@cdr-adr.org.cn。
  • 作者简介:田春华,女,硕士,副主任药师,药品上市后监测与评价。

Enlightenment of Japanese Drug Post-marketing Evaluation System to China

TIAN Chun-hua1, LI Xin-ling1, ZHOU Ran2, XUE Bin2, YANG Wei1,*   

  1. 1 Center for Drug Reevaluation CFDA, Beijing 100045, China;
    2 China Center for Food and Drug International Exchange, Beijing 100082, China
  • Received:2017-11-06 Revised:2017-11-06 Online:2017-09-20 Published:2017-11-06

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摘要： 目的 总结日本上市后评价经验,为我国建立药品上市后评价制度提供参考。方法 通过学术交流和查阅文献,比较日本和我国药品上市后评价的异同。结果 日本上市后评价主要是由再评价和再审查两大制度构成。通过再评价制度解决“老药”的缺陷,同时通过再审查制度推动了“新药”的监测和研究。这些制度有效覆盖了日本所有的药品。结论 日本的药品上市后评价制度极具特色,可为我国构建药品上市后评价体系提供参考。

关键词: 日本, 药品, 上市后, 评价, 再评价, 再审查

Abstract: Objective To provide a reference for the establishment of post-marketing evaluation system in China by summarizing the experience of post-marketing evaluation in Japan. Methods The similarities and differences between drug post-marketing evaluation in China and in Japan were compared by academic exchanges and the literature. Results Japanese post-marketing evaluation is mainly composed of two systems, which were reevaluation and reexamination. The reevaluation system is for solving the "old medicine" defects, and the reexamination system is for promoting the "new drug" monitoring and research. These systems effectively cover all of Japanese medicines. Conclusion Japanese post-marketing evaluation system is very unique, suitable for reference to the construction of Chinese drug post-marketing evaluation system.

Key words: Japan, drug, post-marketing, evaluation, reevaluation, reexamination

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