中国药物警戒 ›› 2016, Vol. 13 ›› Issue (9): 529-532.

• 法规与管理研究 • 上一篇    下一篇

欧盟药品风险管理计划管理研究与启示

田怡, 杨悦, 田丽娟*   

  1. 沈阳药科大学工商管理学院,辽宁 沈阳 110016
  • 收稿日期:2016-10-31 修回日期:2016-10-31 出版日期:2016-09-20 发布日期:2016-10-31
  • 通讯作者: 田丽娟,女,博士,副教授·硕导,合理用药。E-mail：tianlijuan_8@126.com

Study and Enlightenment of Medicines Risk Management Plan in European Union

TIAN Yi, YANG Yue, TIAN Li-juan*   

  1. School of Business Administration, Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China
  • Received:2016-10-31 Revised:2016-10-31 Online:2016-09-20 Published:2016-10-31

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摘要： 目的 对欧盟药品风险管理计划（RMP）的发展历程、实施要素、实施效果等进行研究,以期为我国开展药品RMP提供建议。方法 主要采用文献分析法,检索中外文献和欧洲药品管理局（EMA）网站,了解欧盟RMP内容。结果 欧盟上市许可申请人（MAA）/上市许可持有人（MAH）制定RMP来确保药品风险效益平衡,相关法规和指南完善、组织结构协作分工,已取得良好效果。结论 建议我国从法律层面要求企业制定RMP,作为新药申请材料的一部分,同时完善相关体系,推进RMP发展,实现药品全生命周期的风险管理。

关键词: 风险管理计划, 新药申请, 风险管理

Abstract: Objective To provide suggestions to conduct risk management plan in China by introducing the development, implementation elements and implementation effect of risk management plan (RMP) in European Union. Methods The material of RMP in European Union was summarized through analyzing literature and searching European Medicines Agency (EMA) official website. Results European Union regulations require marketing authorization applicant (MAA) / marketing authorization holder (MAH) develop RMP to ensure drug risk-benefit balance, with perfect regulations and guidelines and organization structure, and has achieved good results. Conclusion China could require companies to develop RMP from a legal perspective, and improve the relevant system, promote the development of RMP, so as to achieve full life-cycle drug risk management.

Key words: risk management plan, registration, risk management

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