美国提高新药审评效率的审评模式改进与思考

中国药物警戒 ›› 2015, Vol. 12 ›› Issue (8): 471-475.

美国提高新药审评效率的审评模式改进与思考

高婧, 杨悦

沈阳药科大学工商管理学院,辽宁沈阳 110016

收稿日期:2015-09-02 修回日期:2015-09-02 出版日期:2015-08-08 发布日期:2015-09-02
通讯作者: 杨悦,女,博士,教授·博导,药事法规与药品政策。E-mail:yyue315@126.com
作者简介:高婧,女,在读硕士,药事管理。

Improvement and Discussion of Review Model for New Drugs in America

GAO Jing, YANG Yue

School of Business Administration, Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China

Received:2015-09-02 Revised:2015-09-02 Online:2015-08-08 Published:2015-09-02

摘要/Abstract

摘要： 目的为完善我国新药审评模式提供参考。方法通过介绍PDUFAV中美国FDA对新分子实体和创新生物制品审评模式的改进,并对实施两年来的效果进行分析,探索其加强沟通、提高审评透明度和首轮通过率的方法,提出几点思考。结果新审评模式合理调整了审评时限,为申请者和审评者提供了充足的时间补充和审评申请材料,里程碑会议的有序召开为双方提供了双向沟通的机会,第三方的评估结果显示,新审评模式有效推进了审评进程,提高了审评透明度和首轮审评通过率,增加了审评的可预见性,尤其对特殊审评药物产生了明显的积极影响。结论对新药审评模式的设计应考虑在保障充足审评资源的前提下,对审评的关键节点加以控制,设置合理审评期限,通过加强申请者和审评者间的沟通提高首轮审评效率和效果。

关键词: PDUFAV, 新药审评模式

Abstract: Objective To provide references for Chinese review model for new drugs. Methods Improved review model for NMENDAs and Original BLAs in PDUFAV was briefly introduced, assessed and analyzed. We explored the way of enhancing communication, review transparency and first-cycle approval rate and some revelations were put forward. Results The new review model adjusts PDUFA review timelimit and gives applicants and review teams enough time to improve and review applications respectively. Milestone meetings offer two-way communication opportunities for them. The third-party assessment shows that new review model promoted review process, improved review transparency and first-cycle approval rates and the review process is more predictable, especially for applications with special designations, such as Breakthrough Therapy and Fast Track. Conclusion When considering new drug review model, we should guarantee adequate review resources, control key review steps and enhance communication between applications and reviewers to improve the efficiency and effectiveness of first-cycle review.

Key words: PDUFAV, new drug review model

中图分类号:

高婧, 杨悦. 美国提高新药审评效率的审评模式改进与思考[J]. 中国药物警戒, 2015, 12(8): 471-475.

GAO Jing, YANG Yue. Improvement and Discussion of Review Model for New Drugs in America[J]. Chinese Journal of Pharmacovigilance, 2015, 12(8): 471-475.

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