摘要
目的:研究美国激励研制罕见儿科疾病药品的"优先审评券计划"制度,为我国制定罕见病药物研发激励政策提供参考。方法:以近年来国外有关"罕见儿科疾病优先审评券"制度的文献为指导,对美国激励研制罕见儿科疾病药品的"优先审评券计划"制度的法规监管要求做具体介绍,分析该制度的实施基础以及实施效果。结果与结论:美国激励研制罕见儿科疾病药品的"优先审评券计划"制度为各国激励药物研发提供了新的思路,未来我国制定罕见病药物研发激励政策时可以重点关注和研究该计划。
Objective:To study the RPV(Priority Review Vouchers)program for encouraging the research and development of drugs for rare pediatric diseases in the United States and to provide references for formulating incentive policies to encourage the research and development of orphan drugs in China.Methods:The regulatory requirements for Priority Review Vouchers system for encouraging the research and development of drugs for rare pediatric diseases in the United States were introduced in detail based on the foreign literature reviews on the Priority Review Vouchers for Rare Pediatric Diseases system in recent years.The foundation of implementing the system and the effect of the implementation were analyzed briefly.Results and Conclusion:Priority Review Vouchers system for encouraging the development of drugs for rare pediatric disease in the United States provides a new idea for encouraging drug research and development in other countries.In the future,the system should be paid special attention to and studied when policies to encourage the research and development of orphan drugs are formulated in China.
作者
潘家梅
张象麟
Pan Jiamei;Zhang Xianglin(School of Business Administration,Shenyang Pharmaceutical University,Shenyang 110016,China)
出处
《中国药事》
CAS
2019年第1期50-55,共6页
Chinese Pharmaceutical Affairs
关键词
罕见儿科疾病
优先审评券
法规监管要求
激励政策
优先审评制度
实施效果
rare pediatric diseases
Priority Review Vouchers
regulatory requirements
incentive policies
priority review systems
effect of implementation
作者简介
潘家梅;研究方向:药事管理;E-mail:1916800047@qq.com;通信作者:张象麟,高级工程师,客座教授;研究方向:药事管理;E-mail:xianglin_zhang@126.com.
