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浅谈《化学药品注册分类改革工作方案》实施后对化学药品研发的影响及对策
浅谈《化学药品注册分类改革工作方案》实施后对化学药品研发的影响及对策
唐金睿,孙 敏,徐丽丽

云南省药物研究所,云南白药集团创新研发中心,云南省中药和民族药新药创制企业重点实验室,昆明 650111
A brief analysis of the influence of implementation of work program for the Reform of Classification of Chemical Medicine Registration on the researchand development of chemical medicines in China and the countermeasures
(Yunnan Institute of Materia Medica,Yunnan Bai Yao Group Innovation and R&D Center,Yunnan Province Company Key Laboratory for TCM and Ethnic Drug of New Drug Creation,Kunming 650111,China)

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起始页:134

摘要:[摘要] 针对《化学药品注册分类改革工作方案》中关于化学药品注册分类的变化,分析其对我国化学药品研发的影响,提出新形势下化学药品研发的对策。

关键词:[关键词] 药品注册;化学药品研发;对策

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Abstract:[Abstract] The article analyzed the influence of the change of the classification of chemical medicine registration which was stipulated in the work program for the Reform of Classification of Chemical Medicine Registration on chemical medicine development, meanwhile put forward countermeasures to the research and development of chemical medicines under new situation. 

Key words:[Key words] drug registration; research and development of chemical medicines; countermeasures

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    [2] 国家食品药品监督管理总局.药品注册管理办法[S].2007.
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    [4] 《国家食品药品监督管理总局关于药品注册审评审批若干政策的公告(2015年第230号)》[EB/OL]. (2015-11-11).http://www.sda.gov.cn/WS01/CL0087/134665.html.