中国药物警戒 ›› 2015, Vol. 12 ›› Issue (4): 219-223.

• 政策与法规研究 • 上一篇    下一篇

中药以植物药新药在美国注册的研究

宋洋1,于志斌2,杨悦1*   

  1. 1沈阳药科大学工商管理学院，辽宁 沈阳 110016;
    2中国医药保健品进出口商会，北京 100010
  • 收稿日期:2015-03-15 出版日期:2015-04-08 发布日期:2015-07-27
  • 通讯作者: 杨悦，女，博士，教授?博导，药事法规与药品政策。
  • 作者简介:宋洋，女，在读硕士，药事法规与药品政策。

Research of Traditional Chinese Medicine Registered as Botanical New Drug in America

SONG Yang1,YU Zhi-bin2,YANG Yue1*   

  1. 1School of Business Administration, Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China;
    2China Chamber of Commerce for Import & Export of Medicines & Health Products, Beijing 100010, China
  • Received:2015-03-15 Online:2015-04-08 Published:2015-07-27

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摘要： 目的 对美国植物药新药审批程序进行介绍，以及对FDA已批准产品和我国正在申报产品特点进行分析，为我国中药企业提供具有实践意义的建议与参考。方法 通过查阅国内外文献，运用文献研究法进行分析；结合相关案例，运用案例分析法进行分析。结果 已获批产品和我国正在申报的品种，具有以下特点：组成成分和有效成分简单明确；适应证选择单一，且主要针对未满足医疗需求疾病或慢性疾病；剂型均为外用剂型或口服剂型；拥有大量基础研究和使用经验。结论 我国中药企业在申报时，宜选择成分相对简单、外用或口服剂型和单一适应证的品种，并考虑开展国际合作。

关键词: 中药, 注册, 临床试验申请, 新药申请

Abstract: Objective According to the introduction of American New Drug Application for botanical drug, and the analysis of the characteristics of products which have been approved by FDA and our being declared products, 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. Case analysis was used to study the classic cases. Results The products which have been approved by FDA and our being declared products have the following characteristics: 1)Constituents/active ingredients are simple and clear. 2) Indications are single and mainly for the illness of unmet medical needs or chronic diseases. 3) Dosage forms are topical formulations or oral dosage forms. 4)Those products have a large number of basic researches and use experience. Conclusion Our traditional Chinese medicine enterprises should choose products with simple ingredients, topical formulations or oral dosage forms, and consider to develop international cooperation.

Key words: traditional Chinese medicine, registration, clinical trial application, new drug application

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