国内外儿童用药研发现状及激励政策比较

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

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。

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.