| 我国近年药品审评审批政策文件分析 |
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| 引用本文： | 陈一飞,金德庄. 我国近年药品审评审批政策文件分析[J]. 世界中医药, 2020, 15(2): 286-295 |
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| 作者姓名： | 陈一飞 金德庄 |
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| 作者单位： | 上海药品审评核查中心,上海,201203 |
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| 摘 要： | 自2015年8月国务院《关于改革药品医疗器械审评审批制度的意见》(国发[2015]44号,44号文)出台以来,我国药品医疗器械审评审批制度改革持续推进。为了更好地理解我国药品审评审批制度改革,本文对我国2015年8月18日至2018年12月31日期间的相关法规政策文件进行检索、梳理、综述,以期对药品行业政策发展趋势进行浅析,对行业提供参考。
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| 关 键 词： | 药品 审评审批 政策文件 分析 |
| 收稿时间： | 2019-04-29 |
Document Analysis on Policies for Drug Evaluation and Approval in China in Recent Years |
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| CHEN Yifei,JIN Dezhuang. Document Analysis on Policies for Drug Evaluation and Approval in China in Recent Years[J]. World Chinese Medicine, 2020, 15(2): 286-295 |
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| Authors: | CHEN Yifei JIN Dezhuang |
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| Affiliation: | Shanghai Center for Drug Evaluation and Verification, Shanghai 201203, China |
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| Abstract: | The promulgation of "Opinions on Reforming the Evaluation and Approval System for Drugs and Medical Instruments" by the State Council in August 2015 initiates continuous reform on the evaluation and approval system for drugs and medical instruments in China.To better understand the reform on the evaluation and approval system for drugs and medical instruments in China, this paper retrieves, summarizes and reviews relevant laws and policies from August 18, 2015 to December 31, 2018, in order to conduct a brief analysis on the development trend of policy in the drug industry, providing reference for the industry. |
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| Keywords: | Drug Evaluation and approval Policy document Analysis |
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