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我国药品优先审评制度的实施情况及建议
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篇名: 我国药品优先审评制度的实施情况及建议
TITLE:
摘要: 目的:为完善我国药品优先审评制度提供参考。方法:先容我国药品特殊审评制度,以及其中药品优先审评制度的基本内容与特点、实施情况、可能存在的问题;分析美国、欧盟、日本的药品优先审评制度的特色,提出完善我国药品优先审评制度的建议。结果与结论:我国先后建立了特别审批、特殊审批、优先审评等特殊审批制度。2017年,国家食品药品监督管理总局发布并实施的《总局关于鼓励药品创新实行优先审评审批的意见》中明确规定了优先审评药品的受理范围、沟通交流机制、提交材料的方式、退出机制以及条件审批等。截至2017年底,共有400多件药品注册申请纳入药品优先审评序列,其中2/3已完成审评,但1类新药的申请上市情况仍不乐观。目前,我国药品优先审评在制度体系(如受理范围过宽泛、纳入标准不明确、监管不明确)、审评程序(如审评时限及纳入程序不明确)、审评机制(如可操作性差)等方面还存在不足。美国、欧盟、日本均制定了高效务实的药品优先审评制度,有覆盖全流程的多通道、多模式、多机制优先审评体系,具有法规体系全面、程序清晰、可操作性强、侧重引导、重视监管等特点。针对上述问题并结合其他国家特点,我国应规范、细化制度和审评程序,加强制度体系建设,加强审评的严谨性、规范性,明确优化审评机制,加强全流程衔接,努力完善和优化我国药品优先审评制度。
ABSTRACT: OBJECTIVE: To provide reference for improving drug priority review system in China. METHODS: Introduce the drug special review system in China, the basic content and characteristics, implementation and problems of drug priority review system, the characteristics of drug priority review system in USA, the European Union, Japan were analyzed to put forward the suggestions for improving drug priority review system in China. RESULTS & CONCLUSIONS: The special review system has been established in China, such as special approval, special review and priority review. In 2017, the scope of drug priority review, communication mechanism, submission of materials, withdrawal mechanism and conditions approval were stated in Opinions of the General Administration on Encouraging Drug Innovation and Implementing Priority Review and Approval published and implemented by State Administration of Food and Drug Supervision. By the end of 2017, more than 400 drug registration approvals were included in drug priority review list, among which two-thirds had completed the review, but the application of class 1 new drug is still not satisfactory. At present, there are still shortcomings in the system (such as wide range of acceptance, unclear inclusion standards, unclear regulation), review procedure (such as review time limit and unclear procedure) and review mechanism (such as poor operability) in China. United States, the European Union and Japan have formulated an efficient and pragmatic drug priority review system, including multi-channel, multi-mode and multi-mechanism priority review system, comprehensive system, clear procedure, strong operability, emphasis on guidance, and attention to supervision and so on. In view of the above problems, based on other national characteristics, it is suggested to standardize and refine system and the review procedure, strengthen the system construction, strengthen the rigor and normalization of the review, optimize the review mechanism, strengthen the whole process connection, improve and optimize drug priority review system in China.
期刊: 2018年第29卷第15期
编辑: 冯媛媛,杨悦
AUTHORS: FENG Yuanyuan,YANG Yue
关键字: 药品;优先审评制度;现状;建议
KEYWORDS: Drug; Priority review system; Situation; Suggestion
阅读数: 352 次
本月下载数: 9 次

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