• 中国核心期刊(遴选)数据库收录期刊
  • 中文科技期刊数据库收录期刊
  • 中国期刊全文数据库收录期刊
  • 中国学术期刊综合评价数据库统计源期刊等

中国药物评价 ›› 2023, Vol. 40 ›› Issue (1): 12-16.

• 产业与政策热点 • 上一篇    下一篇

国内外儿童用药研发现状及激励政策比较

李勇, 胡培杰, 张乐彤   

  1. 中国药科大学国际医药商学院, 江苏 南京 211198
  • 收稿日期:2022-11-14 修回日期:2023-01-19 出版日期:2023-02-28 发布日期:2023-02-28
  • 基金资助:
    江苏省教育厅高校哲学社会科学专题研究项目(2022ZTYJ03)

International Comparative Analysis of Research and Development Status and#br#      Incentive Policies of Pediatric Drugs

  1. International Pharmaceutical Business School of China Pharmaceutical University, Jiangsu Nanjing 211198, China
  • Received:2022-11-14 Revised:2023-01-19 Online:2023-02-28 Published:2023-02-28
  • Contact: Yong Li E-mail:Lsyg168@163.com

摘要: 通过比较我国与欧美发达国家的儿童用药研发现状和激励政策,分析存在的差距,寻找我国儿童用药研发激励政策的短板,借鉴欧美经验为鼓励我国儿童用药的研发提出可行性建议。我国儿童用药激励政策相较于欧美,在药物临床试验、儿童用药信息、新适应证等各个方面均存在明显的差距,应从儿童用药的监管机构、临床试验、研发数据、激励政策体系、专利保护几个方面进行完善和提高,制定更为科学全面的儿童用药研发激励政策。

关键词: font-size:medium, ">儿童用药;药品研发;儿科临床试验;激励政策

Abstract: By comparing the current situation and incentive policies of pediatric drug research and development in China with those developed countries in western, this paper analyzes the gap between the current situation of pediatric drug research and development in China and that in Europe and the United States, and looks for the shortcomings of the incentive policies of pediatric drug research and development in China, and draws on the experience of Europe and the United States to put forward feasible suggestions for pediatric drug research and development in China in the future. Compared with Europe and the United States, there are obvious gaps in drug clinical trials, children ′s medication information, new indications, children ′s medication clinical trial data and other aspects. This paper suggests that China should improve the regulatory agencies, clinical trials, R&D data, incentive policy system and patent protection of pediatric drug use, and formulate more scientific and comprehensive incentive policies for pediatric drug R&D.

Key words: font-size:medium, ">Pediatric drugs; Research and development of the drugs; Pediatric clinical trials; Incentive policy

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