我国加快新药审评审批的进展情况分析及思考
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篇名: 我国加快新药审评审批的进展情况分析及思考
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摘要: 目的:为我国进一步加快新药审评审批及完善相关政策提供参考。方法:统计并分析我国2013年1月1日-2018年1月19日化学药品和生物制品类新药临床试验申请(IND)和新药上市申请(NDA)中,经正常通道和特殊通道申报及获批情况,从而总结问题并提出建议。结果:共有2 759个品种提交了新药IND/NDA,1 462个品种获得批准,总体通过率为53.0%;其中,1 206个品种经特殊通道申请,总体通过率为62.4%(753个)。除预防用生物制品外,我国新药IND获批的中位时长逐年缩短,而NDA获批的中位时长大幅增加;特殊通道的效果在2016年开始显现,而同时获得特殊审批和优先审评审批2个特殊通道的品种其获批的中位时长并没有比单独1个通道短;经特殊通道获批的药品以抗肿瘤和免疫机能调节领域数量最多。结论:我国新药审评审批通过率较低,审批时间较长,特殊通道的作用不明显,且缺乏抗肿瘤药等药品的特殊通道。建议药品检验部门将更多人力投入到拟上市品种的注册检验环节,药品审评机构可建立滚动提交、滚动审评的机制,出台更明确的技术要求以统一审评尺度,并规定发补资料送达后重新启动技术审评的时限,此外,还需进一步明确界定各特殊通道的适用范围。
ABSTRACT: OBJECTIVE: To provide reference for speeding up new drug review and approval and improving related regulations in China. METHODS: Among investigational new drug (IND) application and new drug application (NDA) in chemical drug and biological product during Jan. 1, 2013-Jan. 19, 2018, application acceptance and approval of drugs in normal channel and special channel were summarized and analyzed. The problems were summarized to put forward some suggestions. RESULTS: A total of 2 759 applications were IND/NDA in which 1 462 applications were approved, with an pass rate of 53.0%. Among them, 1 206 products were approved through special channels, and the pass rate was 62.4%(753). In addition to biological products for prevention, median time of IND approval of new drug in China had decreased year by year, but median time of NDA increased greatly. The effect of special pathway began to appear in 2016. The median time of the products that had two special channels which was special approval channel and priority review and approval channel, was not shorter than that of the products that had only one channel. As for the drugs approved through special channels, anti-tumor and immune function regulating drugs had the largest number. CONCLUSIONS: The pass rate of new drugs in China is low, the review and approval time is longer, the role of special channels is not obvious, and special channels for special drugs such as anti-tumor drugs are not available. It is suggested that the QC testing labs put more manpower into the QC testing for NDA products, a rolling submission and rolling review system could be established for drug review and approval. More definite technical requirements could be published so as to unify review standard, the time limit for restarting review clock could be defined after the supplementary materials delivery, and the scope of each special channel shall be clearly defined.
期刊: 2018年第29卷第18期
作者: 任晓星,陈敬,史录文
AUTHORS: REN Xiaoxing,CHEN Jing,SHI Luwen
关键字: 新药临床试验申请;新药上市申请;特殊通道;审评审批
KEYWORDS: Investigational new drug; New drug application; Special channel; Review and approval
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