中国药物警戒 ›› 2021, Vol. 18 ›› Issue (2): 141-144.
DOI: 10.19803/j.1672-8629.2021.02.09

• 法规与管理研究 • 上一篇    下一篇

美国非处方药监管制度浅析与启示

许顺贵, 刘春光*   

  1. 武警北京总队医院药剂科,北京 100027
  • 收稿日期:2020-05-09 修回日期:2021-02-26 出版日期:2021-02-15 发布日期:2021-02-26
  • 通讯作者: *刘春光,硕士,主管药师,药物警戒与合理用药。Liuchunguang2020@163.com
  • 作者简介:许顺贵,本科,副主任药师,医院药学。

Survey of the Regulation System of OTC Drugs in the United States

XU Shungui, LIU Chunguang*   

  1. Department of Pharmacy, Beijing Corps Hospital of Chinese People' s Armed Police Force, Beijing 100027,China
  • Received:2020-05-09 Revised:2021-02-26 Online:2021-02-15 Published:2021-02-26

摘要: 目的 分析美国非处方药监管法规及制度,为完善我国非处方药监管提供参考。方法 查阅美国药品监管部门官方网站及文献,分析美国非处方药上市制度及程序、处方药转换非处方药审评规定、非处方药标签及广告监管工作进展与经验。结果 美国非处方药专论路径节约审评资源、提高监管效率、加快非处方药上市速度,同时积极完善专论制度及流程,应对专论积压等问题。结论 借鉴美国经验,丰富我国非处方药上市路径,创新非处方药上市后监管,充分发挥行业协会作用加强非处方药广告治理,增加消费者用药教育。

关键词: 美国, 非处方药, 监管制度, 专论, 标签, 药品不良反应

Abstract: Objective To provide reference for the improvement of regulation of OTC drugs in China by analyzing the related laws and regulations concerning OTC drugs in the United States. Methods By consulting the official website and literature of the US drug regulatory departments, the author analyzed the progress in the US OTC drug marketing system and procedures, prescription drug conversion, OTC drug labeling and supervision of advertisements. Ways to promote the supervision of China' s OTC drugs were also recommended. Results OTC monograph path saves review resources, improves regulatory efficiency, and speeds up the listing of OTC drugs.in the USA. At the same time, it actively modifies the monograph process to deal with the backlog of monographs and inefficient review. Conclusion It is recommended that marketing methods of OTC drugs be diversified in China by learning from the United States. We should innovate the post marketing supervision of OTC drugs, bring into full play the role of industry associations, tighten the control over OTC advertising, and help consumers learn more about drug use.

Key words: the United States, over-the-counter drugs, regulations, monograph, labeling, adverse drug reaction

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