中国药物警戒 ›› 2015, Vol. 12 ›› Issue (9): 547-551.

• 政策与法规研究 • 上一篇    下一篇

我国中药以OTC药品身份在美国上市途径探讨

宋洋, 尤晓敏, 宗毛毛, 杨悦   

  1. 沈阳药科大学工商管理学院，辽宁 沈阳 110016
  • 收稿日期:2015-08-12 修回日期:2015-12-07 出版日期:2015-09-08 发布日期:2015-12-07
  • 通讯作者: 杨悦，女，教授·博导，药事法规与药品政策。E-mail:yyue315@126.com
  • 作者简介:宋洋，女，在读硕士，药事法规与药品政策。

Research of How Traditional Chinese Medicine Can Be Registered as OTC Drug in USA

SONG Yang, YOU Xiao-min, ZONG Mao-mao, YANG Yue   

  1. School of Business Administration, Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China
  • Received:2015-08-12 Revised:2015-12-07 Online:2015-09-08 Published:2015-12-07

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摘要： 目的 对美国OTC药品专论审评体系进行介绍，为我国中药企业提供具有实践意义的建议与帮助。方法 通过查阅国内外文献，运用文献研究法进行分析。结果 申请人可通过公民请愿书和TEA程序，申请将产品所含新活性成分纳入到现有专论或建立新专论。结论 我国中药企业在申报时，可选择活性成分为OTC药品专论中所含成分的植物药品种，对有关目标药品专论的历年讨论稿进行了解，以及规范植物药产品说明书，注意可读性要求。

关键词: 植物药, 非处方药专论, 公民请愿书, 销售历时及覆盖范围申报

Abstract: Objective According to the introduction of American OTC Drug Monograph, practical advice and help were put forward to provide the example and reference for our traditional Chinese medicine enterprises. Methods Literature study was used to analyze the foreign and domestic materials. Results The applicants can bring new active ingredients which are contained in their products into the existing monographs or make new monographs for them. Conclusion Our traditional Chinese medicine enterprises should choose products whose active ingredients have been contained in the existing monographs and have knowledge of all the discussion papers related to the targeted monographs. In Addition, the applicants should also pay attention to standardizing the labellings of botanical drugs, especially the readability requirements.

Key words: botanical drug, OTC Drug Monograph, citizen petition, time and extent application

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