欧盟儿科药品监管法的实施成就、经验和教训

Achievements, Experiences and Problems of the Implementation of the Pediatric Regulation of EMA

目的:研究借鉴欧盟儿科用药监管法规及经验,促进儿科用药行业发展。方法:采用文献法对欧洲药品管理局网站儿科药法规相关内容进行了深入研究,并以"儿科药""儿童药""法规"等为关键词检索欧盟及国内儿科用药监管法规,并比较中国与欧盟儿科用药法规。结果:欧盟儿科法规实施8年后儿科药物发展取得了进步,儿科临床试验数量明显增加,参与临床研究的儿科人群数量大幅增加,但同时也有一部分预期目标未能实现。我国与欧洲相比,法规建设还有很多亟需完善之处。结论:儿科法规对儿科药物发展有极大的促进和推动作用,我国应加快儿科法规建设。

Objective： To study the effect of pediatric regulation on the development of the industry. Methods： Firstly, the European pediatric regulation was reviewed systematically. Secondly, the development of Chinese pediatric medicine was summarized. Thirdly, legislative was analyzed comparatively. Results： Remarkable achievement has been made with the implementation of the EU pediatric regulation, the figures in the Eudr ACT database have shown an increase in pediatric trials, the and number of participants in clinical trials has significantly increased. However, at the same time, there is also a part of the expected target not be achieved, such as the PUMA concept failing to fulfill the initial expectations. Conclusion： Pediatric regulation has great promotion for the development of pediatric medicine, the construction of pediatric regulation should be accelerated.