| 潘家梅,张象麟.美国激励研制罕见儿科疾病药品的“优先审评券计划”制度概述[J].中国药事,2019,33(1):50-55 |
| 美国激励研制罕见儿科疾病药品的“优先审评券计划”制度概述 |
| Overview of the PRV System for Encouraging the Research and Development of Drugs for Rare Pediatric Diseases in the United States |
| 投稿时间：2018-04-10 |
| DOI：10.16153/j.1002-7777.2019.01.009 |
| 中文关键词: 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 |
| 英文关键词: rare pediatric diseases Priority Review Vouchers regulatory requirements incentive policies priority review systems effect of implementation |
| 基金项目: |
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| 摘要点击次数: 1425 |
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| 中文摘要: |
| 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。 |
| 英文摘要: |
| 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. |
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