中国药物警戒 ›› 2019, Vol. 16 ›› Issue (4): 208-211.

• 法规与管理研究 • 上一篇    下一篇

2018年50个新药快速上市对安全监测的挑战与建议

王越1, 李明2   

  1. 1江苏省药品监督管理局,江苏 南京 210008;
    2江苏省药品不良反应监测中心,江苏 南京 210002
  • 收稿日期:2019-05-09 修回日期:2019-05-09 出版日期:2019-04-20 发布日期:2019-05-09
  • 作者简介:王越,男,博士,主任药师,药品监管。
  • 基金资助:
    国家药品监督管理局：加强创新药监测和监管的建议

Challenges and Suggestions for Safety Monitoring of 50 New Drugs Accelerated Approval in 2018

WANG Yue1, LI Ming2   

  1. 1Jiangsu Provincial Drug Administration, Jiangsu Nanjing 210008;
    2Center for ADR Monitoring of Jiangsu, Jiangsu Nanjing 210002
  • Received:2019-05-09 Revised:2019-05-09 Online:2019-04-20 Published:2019-05-09

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摘要： 目的 为新药上市后开展安全监测提供建议。方法 通过查阅文献、数据库、药品说明书,对2018年50个新药的适应证分类、不良反应概况和安全风险因素等进行分析。结果 新药快速上市,潜在风险暴露不足,给上市后安全监测带来严峻挑战。结论 新药持有人、医疗机构、监测机构、监管部门等应履行《关于药品上市许可持有人直接报告不良反应事宜的公告》的职责,积极开展新药上市后风险监测工作。

关键词: 新药, 药品上市许可持有人, 药品不良反应直接报告制度

Abstract: Objective To provide suggestions for safety monitoring of new drugs after marketing. Methods By consulting literature, databases and drug instructions, the indications, adverse reactions and safety risk factors of 50 new drugs in 2018 were analyzed. Results The accelerated approval of new drugs and insufficient exposure to potential risks posed severe challenges to post-marketing safety monitoring. Conclusion New drug Marketing Authorization Holders(MAH), medical institutions, monitoring agencies and regulatory authorities should fulfill the duty of notice on the Direct Reporting of Adverse Drug Reactions(ADRs) and actively carry out post-marketing risk monitoring of new drugs.

Key words: new drug, Marketing Authorization Holders(MAH), Direct Reporting of Adverse Drug Reactions

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