美国与欧盟药物研制中的儿童用药研究计划初探

Exploration of Pediatric Study/Investigation Plan in Drug Research and Development in the US and the EU

目的:详细介绍了美国、欧盟法规中的儿童用药研发计划,希望为我国的儿童用药法规提供参考和借鉴。方法:分析、对比美国和欧盟的儿童用药研发计划,同时对我国目前的儿童用药政策作了简要介绍。结果与结论:我国的儿童用药法规可以借鉴美国与欧盟的经验,逐步推进儿童用药研发计划的做法。

Objective： To present the FDA pediatric study plan and EMA pediatric investigation plans in detail, to provide references for pediatric regulations in China. Method： The pediatric study plans in the US and the EU were analyzed and compared. The pediatric regulations and guidelines in China were briefly introduced. Results and Conclusion： China may learn experiences from the US and the EU, so as to gradually promote the pediatric research plan.