文章摘要
陈宁,杨建红,潘红波,栗艳彬,郑瑞霞,贾卡,董凌云,黎泽琳,陈震.美国和日本非处方药专论路径研究及对我国的启示[J].中国药事,2020,34(11):1239-1246
美国和日本非处方药专论路径研究及对我国的启示
Study on the Process of Over-the-counter Drugs in the United States and Japan and the Implication for China
  
DOI：10.16153/j.1002-7777.2020.11.001
中文关键词: 药品分类管理  非处方药  上市路径  专论路径
英文关键词: drug classification management  over the counter drug (OTC)  marketing process  monograph process
基金项目:
作者单位
陈宁 郑州大学药学院,郑州 450001 
杨建红 沈阳药科大学亦弘商学院,北京 100055 
潘红波 赛诺菲(中国)投资有限公司,北京 100022 
栗艳彬 百济神州(北京)生物科技有限公司,北京 100022 
郑瑞霞 参天制药(中国)有限公司,北京 100738 
贾卡 惠氏制药有限公司,上海 200041 
董凌云 北京亦度正康健康科技有限公司,北京 100055 
黎泽琳 沈阳药科大学工商管理学院,沈阳 110016 
陈震 郑州大学药学院,郑州 450001 ；沈阳药科大学亦弘商学院,北京 100055 
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中文摘要:
      目的：探讨我国建立非处方药专论路径的可行性。方法：采用文献研究法和对比分析法，对比美国和日本非处方药专论路径的出台背景、主要内容以及专论制定程序等，分析美国和日本专论路径的风险管控措施。结果：美国和日本针对低风险产品建立专论路径，体现了基于风险对药品实施分类管理的理念，以专论建立过程中的有效风险管控为前提，简化专论产品上市的审评审批，有利于节约审评资源，提高监管效率，更好地满足公众的用药需求。结论：建议借鉴美国和日本的经验，开展我国非处方药专论路径的试点工作。
英文摘要:
      Objective: To explore the feasibility of establishing the OTC drug monograph process in China. Methods: To introduce background and main content of the OTC drug monograph process, as well as monograph establishment procedures in the United States and Japan were compared by literature research and comparative analysis, and the risk control measures of the US-Japan monograph process were analyzed. Results: The establishment of monograph process for low-risk products in the United States and Japan reflects the concept of classification management of drugs based on risk. On the premise of effective risk management and control in the process of monograph establishment, simplifying the review and approval of monograph products is beneficial to economize review resources, improve regulatory efficiency, and better meet the public's requirement for OTC drug. Conclusion: It is recommended to draw on the experience of the United States and Japan to carry out pilot work on the OTC monograph process in China.
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