儿童药物的开发策略  

Strategies for the Research and Development of Pediatric Drugs

作　　者：萧凤鸣 SIU Annie Fung-ming(Pharma Intelligence,Informa PLC,Hong Kong,China)

机构地区：[1]英富曼集团医药情报部

出　　处：《药学进展》2019年第9期644-654,共11页Progress in Pharmaceutical Sciences

摘　　要：中国近年发布了药物法规方面的新政策,包括鼓励儿童药品开发。对以符合儿童用药为由被纳入优先审评审批名单的80项药物注册申请进行了分析,发现境外药物和罕见病药物占据了一定比重。结合Informa的Pharmaprojects、Biomedtracker和Medtrack数据库的数据分析结果,提出了儿童药物开发的3个策略:关注境外上市的儿童药物、以罕见病为适应证进行药物开发、与拥有儿童药物剂型核心开发技术的团队合作,旨在为儿童药物研发企业提供参考。New policies on drug regulation have been issued in China in recent years, including encouraging R&D of pediatric drugs. We analyzed 80 drug registration applications for pediatric drugs included in the priority review and approval list, and found that drugs from outside China’s mainland and orphan drugs accounted for a certain proportion. Based on the data analysis results by Pharmaprojects, Biomedtracker and Medtrack of Informa, three strategies for the research and development of pediatric drugs are proposed, so as to provide reference for related pharmaceutical enterprises, with much attention to the newly marketed pediatric drugs outside China’s mainland, the development of drugs against rare diseases, and cooperating with teams holding key development technologies for pediatric drug formulation.

关 键 词：儿童用药 优先审评 孤儿药 药物输送技术 

分 类 号：R985[医药卫生—药品]