中国药物警戒 ›› 2020, Vol. 17 ›› Issue (2): 65-71.
DOI: 10.19803/j.1672-8629.2020.02.01

• 专家论坛 • 上一篇    下一篇

我国药物警戒制度实施与ICH药物警戒指导原则转化适用

杨悦1,2   

  1. 1沈阳药科大学药品监管科学研究院,辽宁 沈阳 110016;
    2沈阳药科大学国际食品药品政策与法律研究中心,辽宁 沈阳 110016
  • 收稿日期:2019-12-14 修回日期:2020-06-22 出版日期:2020-02-15 发布日期:2020-02-26
  • 作者简介:杨悦,女,博士,教授,博导,药事管理与药物警戒研究。

Implementation of Pharmacovigilance System in Drug Administration Law and Application of ICH E2 Guideline

YANG Yue1,2   

  1. 1Research Institute of Drug Regulatory Science, Shenyang Pharmaceutical University, Shenyang Liaoning 110016, China;
    2International Center for Food and Drug Policy and Law, Shenyang Pharmaceutical University, Shenyang Liaoning 110016, China
  • Received:2019-12-14 Revised:2020-06-22 Online:2020-02-15 Published:2020-02-26

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摘要： 本文将原《药品管理法》中药品不良反应报告和监测制度与新修订《药品管理法》中的药物警戒制度要求差异进行分析,从药物警戒涵义入手,结合我国药品审评审批改革以来新药上市加速的宏观背景,指出药物警戒制度应当作为新药上市审评进入“高速路”的制动机制。与ICH E2系列指导原则转化应用相结合,对落实新修订《药品管理法》中药物警戒要求提出转变监测和报告理念,提高信号检测效率和能力,开展累积性风险获益评价,探索适合中国国情的风险管理计划要求等具体建议和思路。

关键词: 药品管理法, 药物警戒, ICH E2, 不良事件, 风险管理计划

Abstract: This paper is intended to analyze the difference in adverse reaction reporting and monitoring systems between the previous Drug Administration Law and the pharmacovigilance system specified in the newly revised Drug Administration Law. Starting with the meaning of pharmacovigilance and combined with the macro background of acceleration of new drug authorization since the reform of drug review and approval in China, this paper points out that the pharmacovigilance system can be compared to the braking mechanism for new drug review to enter the “expressway”. Combined with the transformation and application of ICH E2 series guidelines, this paper makes recommendations for the implementation of pharmacovigilance requirements according to the revised Drug Administration Law, such as changing notions about the monitoring and reporting of drugs, improving the efficiency and ability of signal detection, carrying out cumulative risk benefit evaluation, and exploring the requirements of risk management plans suited to China.

Key words: Drug Administration Law, pharmacovigilance, ICH E2, adverse event, risk management plan

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