美国竞争性仿制药激励制度述评及对我国的启示
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篇名: 美国竞争性仿制药激励制度述评及对我国的启示
TITLE: Review of the competitive generic drug incentive system in the United States and its enlightenment to China
摘要: 目的 为促进我国仿制药产业和制度发展提供思路和启发。方法通过文本分析、实证研究等方式,梳理美国竞争性仿制药激励制度,分析其实施效果和成功经验,为我国相关制度的实施提供参考。结果美国竞争性仿制药激励制度通过发布《尚无已批准仿制药的已过专利期及独占期药品清单》,明确鼓励仿制的范围,同时对这些竞争不充分的仿制药采取加快开发和审查、给予市场独占期优待等措施,在激励仿制药申请、加速仿制药上市、促进药价降低方面取得了良好效果,有利于提高药物可及性。结论我国借鉴美国竞争性仿制药激励制度符合国内药品供给现状的需要,也具有行业实践基础;可借鉴美国经验,完善我国鼓励仿制药品目录发布制度,优化鼓励仿制药品的审批流程,并给予鼓励仿制药品独占期。
ABSTRACT: OBJECTIVE To provide ideas and inspiration for promoting the development of the generic drug industry and legal system of China. METHODS With text analysis, empirical research and other methods, the competitive generic drug incentive system in the United States was combed, its implementation effect and successful experience were analyzed, and the reference was provided for the implementation of relevant systems in China. RESULTS The competitive generic drug incentive system in the United States had achieved a satisfactory effect in three aspects: encouraging generic drug applications, accelerating the listing of generic drugs, and promoting drug price reduction, which was ultimately conducive to improving drug accessibility by publishing List of Off-Patent,Off-Exclusivity Drugs without an Approved Generic, while accelerating the development and review of generic drugs with insufficient competition and giving market exclusivity periods. CONCLUSIONS China’s reference to the competitive generic drug incentive system in the United States meets the needs of the current situation of domestic drug supply and also has the basis for industry practice. Therefore, we can refer to it, improve the system of releasing the catalog of encouraged generic drugs to be imitated, optimize the approval process for them, and authorize the exclusive period incentive to them.
期刊: 2023年第34卷第13期
作者: 郭斯伦;马韶青
AUTHORS: GUO Silun,MA Shaoqing
关键字: 竞争性仿制药激励制度;美国;实施效果;制度借鉴
KEYWORDS: competitive generic drug incentive system; the United States; implementation effect; system reference
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