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2005—2016年我国Ⅰ类新药申报审批情况分析
2005—2016年我国Ⅰ类新药申报审批情况分析
樊玉录,陈玉文

沈阳药科大学工商管理学院
An analysis of the registration and approvals for class of innovative drug during 2005—2016 in China
(School of Business Administration,Shenyang Pharmaceutical University,Shenyang 110016,China)

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起始页:142

摘要:[摘要] 通过对2005—2016年我国Ⅰ类新药的注册申报审批情况进行统计检索,并对其申报数量、申报的治疗类别、审评结论等方面进行系统对比分析,结果发现2005—2016年我国Ⅰ类新药申报数量为855个,批准上市32个,上市批准率仅为3.76%,批准生产品种治疗类别主要集中在抗肿瘤和抗感染领域。由此可见,创新药不但要有全新的物质结构,也要符合以临床价值为导向的特点。

关键词:[关键词] Ⅰ类新药;新药研发;药品注册;回顾分析

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Abstract:[Abstract] This paper indexed the registrations and applications of all class I of innovative drugs during 2005—2016 through database, and analyzed their amounts,indications and conclusions of approval. The results showed that the number of class I of innovative drug in China was 855 during 2005—2016, 32 was approved and the approval rate was only 3.76%. The categories of innovative drug are focused on the area of anti-tumor and anti-infection. Therefore, innovative drugs should not only have new structures, but also meet clinical requirements.

Key words:[Key words] class I of innovative drug; new drug research and development; drug registration; retrospective analysis

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