中国药物警戒 ›› 2017, Vol. 14 ›› Issue (3): 158-160.

• 药物警戒概念与制度研究 • 上一篇    下一篇

日本药品上市后评价制度研究

刘佳1, 李承霖2, 郭俐宏2, 河合秀晃3, 寺井嘉哉3, 岩崎典之3, 铃木美和子3, 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 安斯泰莱制药（中国）有限公司,北京 100022;
    3 アステラス製薬株式会社,日本 东京 103-8411
  • 收稿日期:2017-04-20 修回日期:2017-04-20 出版日期:2017-03-20 发布日期:2017-04-20
  • 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:刘佳,男,硕士,工程师,药品上市后监测与评价。
  • 基金资助:
    国家食品药品监督管理总局课题（C201501）：药物警戒法律制度比较研究

Research on System of Post-marketing Evaluation in Japan

LIU Jia1, LI Cheng-lin2, GUO Li-hong2, Kawai Hideaki3, Terai Yoshiya3, Iwasaki Noriyuki3, Suzuki Miwako3, YANG Wei*   

  1. 1 Centre for Drug Reevaluation,CFDA, Beijing 100045, China;
    2 Astellas Pharma China, Inc., Beijing 100022;
    3 Astellas Pharma, Inc., Tokyo 103-8411, Japan
  • Received:2017-04-20 Revised:2017-04-20 Online:2017-03-20 Published:2017-04-20

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摘要： 目的 学习和总结发达国家药品上市后评价制度设计和框架,为建立我国药品上市后评价体系提供参考。方法 查阅并总结日本药品上市后评价相关文献资料。结果 日本通过30年的法规修订,形成了以药品不良反应和感染报告制度为基础、再审查制度为主线的药品上市后评价体系,内容涵盖上市后早期监测（EPPV）、定期安全性更新报告（PSUR）、风险管理计划（RMP）以及药物使用效果调查等制度。制度的执行严格遵循药物警戒质量管理规范（GVP）和上市后研究质量管理规范（GPSP）要求。此外,针对超出再审查期的药品还建立了即时再评价制度作为补充。结论 日本已形成一套完善的药品上市后评价体系,相关经验对我国开展相关工作具有参考意义。

关键词: 日本, 药品, 上市后, 评价

Abstract: Objective To provide references for the post-marketing evaluation system in china by studying and summarizing the design and framework of the post-marketing drug evaluation system in developed countries. Methods The related literatures of post-marketing evaluation in Japan were reviewed and summarized. Results Japan has established a post-marketing drug evaluation system which is based on the adverse drug reactions and infection reporting system. The reexamination system that includes Early Post-marketing Phase Vigilance (EPPV), Period Safety Update Report (PSUR), Risk Management Plan (RMP) and drug use investigation is the main line for this post-marketing drug evaluation system. The implement of the system must be follow Good Vigilance Practice (GVP) and Good Post-marketing Study Practice (GPSP). Additionally, an Ad Hoc reevaluation system is established as a part of post-marketing drug evaluation system for the drugs out of the reexamination period. Conclusion Japan has developed a comprehensive system for drug post-marketing evaluation. The experience in the post-marketing evaluation system from Japan has a reference value for China to carry out related work.

Key words: Japan, medicine, post-marketing, evaluation

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