中国的药品加快审批路径概览

doi:10.5246/jcps.2017.06.050

中国药学(英文版) ›› 2017, Vol. 26 ›› Issue (6): 455-459.DOI: 10.5246/jcps.2017.06.050

• 【药事管理与临床药学专栏】 • 上一篇下一篇

中国的药品加快审批路径概览

田恬^*

科技导报社, 北京 100081

收稿日期:2017-04-15 修回日期:2017-04-30 出版日期:2017-06-29 发布日期:2017-05-25
通讯作者: Tel.: +86-010-62185026, E-mail: tiantian@cast.org.cn

An overview of expedited approaches in China’s drug review and approval regulation

Tian Tian^*

Science and Technology Review Publishing House, Beijing 100081, China

Received:2017-04-15 Revised:2017-04-30 Online:2017-06-29 Published:2017-05-25
Contact: Tel.: +86-010-62185026, E-mail: tiantian@cast.org.cn

摘要/Abstract

摘要：

近期, CFDA发布了一系列药品注册审评制度改革的文件, 希望通过优化新药的审批路径, 来促进新药的上市, 以满足日益扩大的临床需求。本文总结了中国药品加快审批的路径, 并与美国FDA的成功经验进行比较, 总结其中存在的特征与问题。目前, 中国正在逐步推动建立药品的加快审批路径, 希望可以使新药研发和患者共同受益。

关键词: 优先审评, 药品审评, 药品审批法规

Abstract:

Nowadays, CFDA has released a series of reform documents in drug registration review system, which may optimize the new drug evaluation model to accelerate the development of drugs. In this review, we summarized the qualifications and features of expedited approaches in drug review and approval in China, and compared these approaches with FDA. In conclusion, the expedited programs of drug approval in China have been gradually established and translated into policy benefits for drug makers and patients.

Key words: Priority review, Drug review, Drug approval regulation

中图分类号:

R951

Supporting:

田恬. 中国的药品加快审批路径概览[J]. 中国药学(英文版), 2017, 26(6): 455-459.

Tian Tian. An overview of expedited approaches in China’s drug review and approval regulation[J]. Journal of Chinese Pharmaceutical Sciences, 2017, 26(6): 455-459.

参考文献

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[4] FDA. Fast Track Drug Development Programs-Designation, Development, and Application Review [EB/OL]. 2015-12-30. http://www.fda.gov/BiologicsBloodVaccines/Guidance ComplianceRegulatoryInformation/ProceduresSOPPs/ucm073515.htm

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中国的药品加快审批路径概览

An overview of expedited approaches in China’s drug review and approval regulation

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