国内外儿童用药鼓励研发政策比较

摘要

儿童用药问题一直是世界各国面临的难题，其中最重要的两个问题是缺少儿童适用的药品剂型规格，以及缺乏儿童使用药物的安全性及有效性数据。如何激励药品研发生产企业生产适宜儿童使用的药品品种、规格和剂型，引导药品生产厂家获得儿童用药数据，是儿童用药当前最主要的工作。本文通过参考国内外文献，系统介绍了美国、欧盟、日本等国家和地区鼓励儿童用药研发的政策和措施，包括儿童用药相关法案、儿童用药相关机构的组成及功能、对儿童用药研发的激励措施、对儿童用药数据研究的强制措施以及对儿童用药研究的帮扶举措。同时梳理了中国近年来儿童用药研发的相关举措，为进一步完善中国相关制度提供参考。%The problem of pediatric drugs has been the challenges facing the world. The two most important issues are the lack of appropriate drug dosage forms for children and the safety and effectiveness data of drug use in children. How to encourage produc⁃tion enterprises to produce drug varieties,specifications and dosage forms suitable for children use,guide drug manufacturers to ob⁃tain drug use data are the most important work for pediatric drugs.Based on the literature home and abroad,we analyze the regulatory policies for the research and development(RD)and application of pediatric drugs in the USA,EU and Japan,which have made great efforts to encourage enterprises to conduct pediatric research. Their successful experiences are summarized and can be used as refer⁃ence for the establishment of the policies adaptive to the situation of China for the RD of pediatric drugs.