| 赵岩松,洪兰,叶桦.美国与欧盟药物研制中的儿童用药研究计划初探[J].中国药事,2017,(4):358-363 |
| 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 |
| 投稿时间：2016-09-13 |
| DOI：10.16153/j.1002-7777.2017.04.003 |
| 中文关键词: 儿童用药研究计划 药品研制 政策法规 |
| 英文关键词: pediatric study plan drug research and development regulation and guideline |
| 基金项目: |
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| 中文摘要: |
| 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。 |
| 英文摘要: |
| 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. |
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