# 2.临床试验申请 > 共 **47** 个PDF文件 ## 2.1注册分类 - [20200630_NMPA_关于发布化学药品注册分类及申报资料要求的通告（2020年第44号）](/upload/20200630_NMPA_%E5%85%B3%E4%BA%8E%E5%8F%91%E5%B8%83%E5%8C%96%E5%AD%A6%E8%8D%AF%E5%93%81%E6%B3%A8%E5%86%8C%E5%88%86%E7%B1%BB%E5%8F%8A%E7%94%B3%E6%8A%A5%E8%B5%84%E6%96%99%E8%A6%81%E6%B1%82%E7%9A%84%E9%80%9A%E5%91%8A%EF%BC%882020%E5%B9%B4%E7%AC%AC44%E5%8F%B7%EF%BC%89.pdf) - [20200630_NMPA_关于发布生物制品注册分类及申报资料要求的通告（2020年第43号）](/upload/20200630_NMPA_%E5%85%B3%E4%BA%8E%E5%8F%91%E5%B8%83%E7%94%9F%E7%89%A9%E5%88%B6%E5%93%81%E6%B3%A8%E5%86%8C%E5%88%86%E7%B1%BB%E5%8F%8A%E7%94%B3%E6%8A%A5%E8%B5%84%E6%96%99%E8%A6%81%E6%B1%82%E7%9A%84%E9%80%9A%E5%91%8A%EF%BC%882020%E5%B9%B4%E7%AC%AC43%E5%8F%B7%EF%BC%89.pdf) ## 2.2加快注册程序考虑 - [20051108_NMPA_《国家食品药品监督管理局药品特别审批程序》（局令第21号）](/upload/20051108_NMPA_%E3%80%8A%E5%9B%BD%E5%AE%B6%E9%A3%9F%E5%93%81%E8%8D%AF%E5%93%81%E7%9B%91%E7%9D%A3%E7%AE%A1%E7%90%86%E5%B1%80%E8%8D%AF%E5%93%81%E7%89%B9%E5%88%AB%E5%AE%A1%E6%89%B9%E7%A8%8B%E5%BA%8F%E3%80%8B%EF%BC%88%E5%B1%80%E4%BB%A4%E7%AC%AC21%E5%8F%B7%EF%BC%89.pdf) - [20200708_NMPA_关于发布《突破性治疗药物审评工作程序（试行）》等三个文件的公告（2020年第82号）](/upload/20200708_NMPA_%E5%85%B3%E4%BA%8E%E5%8F%91%E5%B8%83%E3%80%8A%E7%AA%81%E7%A0%B4%E6%80%A7%E6%B2%BB%E7%96%97%E8%8D%AF%E7%89%A9%E5%AE%A1%E8%AF%84%E5%B7%A5%E4%BD%9C%E7%A8%8B%E5%BA%8F%EF%BC%88%E8%AF%95%E8%A1%8C%EF%BC%89%E3%80%8B%E7%AD%89%E4%B8%89%E4%B8%AA%E6%96%87%E4%BB%B6%E7%9A%84%E5%85%AC%E5%91%8A%EF%BC%882020%E5%B9%B4%E7%AC%AC82%E5%8F%B7%EF%BC%89.pdf) - [20200709_CDE_关于“突破性治疗药物程序申请系统”和新版“优先审评审批申请系统”上线的通知](/upload/20200709_CDE_%E5%85%B3%E4%BA%8E%E2%80%9C%E7%AA%81%E7%A0%B4%E6%80%A7%E6%B2%BB%E7%96%97%E8%8D%AF%E7%89%A9%E7%A8%8B%E5%BA%8F%E7%94%B3%E8%AF%B7%E7%B3%BB%E7%BB%9F%E2%80%9D%E5%92%8C%E6%96%B0%E7%89%88%E2%80%9C%E4%BC%98%E5%85%88%E5%AE%A1%E8%AF%84%E5%AE%A1%E6%89%B9%E7%94%B3%E8%AF%B7%E7%B3%BB%E7%BB%9F%E2%80%9D%E4%B8%8A%E7%BA%BF%E7%9A%84%E9%80%9A%E7%9F%A5.pdf) - [20201119_CDE_关于发布《药品附条件批准上市技术指导原则（试行）》的通告（2020年第41号）](/upload/20201119_CDE_%E5%85%B3%E4%BA%8E%E5%8F%91%E5%B8%83%E3%80%8A%E8%8D%AF%E5%93%81%E9%99%84%E6%9D%A1%E4%BB%B6%E6%89%B9%E5%87%86%E4%B8%8A%E5%B8%82%E6%8A%80%E6%9C%AF%E6%8C%87%E5%AF%BC%E5%8E%9F%E5%88%99%EF%BC%88%E8%AF%95%E8%A1%8C%EF%BC%89%E3%80%8B%E7%9A%84%E9%80%9A%E5%91%8A%EF%BC%882020%E5%B9%B4%E7%AC%AC41%E5%8F%B7%EF%BC%89.pdf) ## 2.3沟通交流 - [20120716_CDE_药品审评中心与注册申请人沟通交流质量管理规范（试行）](/upload/20120716_CDE_%E8%8D%AF%E5%93%81%E5%AE%A1%E8%AF%84%E4%B8%AD%E5%BF%83%E4%B8%8E%E6%B3%A8%E5%86%8C%E7%94%B3%E8%AF%B7%E4%BA%BA%E6%B2%9F%E9%80%9A%E4%BA%A4%E6%B5%81%E8%B4%A8%E9%87%8F%E7%AE%A1%E7%90%86%E8%A7%84%E8%8C%83%EF%BC%88%E8%AF%95%E8%A1%8C%EF%BC%89.pdf) - [20170309_NMPA_关于发布药品注册审评专家咨询委员会管理办法（试行）的公告（2017年第27号）](/upload/20170309_NMPA_%E5%85%B3%E4%BA%8E%E5%8F%91%E5%B8%83%E8%8D%AF%E5%93%81%E6%B3%A8%E5%86%8C%E5%AE%A1%E8%AF%84%E4%B8%93%E5%AE%B6%E5%92%A8%E8%AF%A2%E5%A7%94%E5%91%98%E4%BC%9A%E7%AE%A1%E7%90%86%E5%8A%9E%E6%B3%95%EF%BC%88%E8%AF%95%E8%A1%8C%EF%BC%89%E7%9A%84%E5%85%AC%E5%91%8A%EF%BC%882017%E5%B9%B4%E7%AC%AC27%E5%8F%B7%EF%BC%89.pdf) - [20171219_CDE_关于药品注册审评专家咨询委员会初选名单的公示](/upload/20171219_CDE_%E5%85%B3%E4%BA%8E%E8%8D%AF%E5%93%81%E6%B3%A8%E5%86%8C%E5%AE%A1%E8%AF%84%E4%B8%93%E5%AE%B6%E5%92%A8%E8%AF%A2%E5%A7%94%E5%91%98%E4%BC%9A%E5%88%9D%E9%80%89%E5%90%8D%E5%8D%95%E7%9A%84%E5%85%AC%E7%A4%BA.pdf) - [20180724_CDE_关于调整药物临床试验审评审批程序的公告（2018年第50号）](/upload/20180724_CDE_%E5%85%B3%E4%BA%8E%E8%B0%83%E6%95%B4%E8%8D%AF%E7%89%A9%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E5%AE%A1%E8%AF%84%E5%AE%A1%E6%89%B9%E7%A8%8B%E5%BA%8F%E7%9A%84%E5%85%AC%E5%91%8A%EF%BC%882018%E5%B9%B4%E7%AC%AC50%E5%8F%B7%EF%BC%89.pdf) - 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[20201203_CDE_关于发布《单臂试验支持上市的抗肿瘤药进入关键试验前临床方面沟通交流技术指导原则》的通告（2020年第47号）](/upload/20201203_CDE_%E5%85%B3%E4%BA%8E%E5%8F%91%E5%B8%83%E3%80%8A%E5%8D%95%E8%87%82%E8%AF%95%E9%AA%8C%E6%94%AF%E6%8C%81%E4%B8%8A%E5%B8%82%E7%9A%84%E6%8A%97%E8%82%BF%E7%98%A4%E8%8D%AF%E8%BF%9B%E5%85%A5%E5%85%B3%E9%94%AE%E8%AF%95%E9%AA%8C%E5%89%8D%E4%B8%B4%E5%BA%8A%E6%96%B9%E9%9D%A2%E6%B2%9F%E9%80%9A%E4%BA%A4%E6%B5%81%E6%8A%80%E6%9C%AF%E6%8C%87%E5%AF%BC%E5%8E%9F%E5%88%99%E3%80%8B%E7%9A%84%E9%80%9A%E5%91%8A%EF%BC%882020%E5%B9%B4%E7%AC%AC47%E5%8F%B7%EF%BC%89.pdf) - [20201211_CDE_关于发布《药物研发与技术审评沟通交流管理办法》的通告（2020年第48号）](/upload/20201211_CDE_%E5%85%B3%E4%BA%8E%E5%8F%91%E5%B8%83%E3%80%8A%E8%8D%AF%E7%89%A9%E7%A0%94%E5%8F%91%E4%B8%8E%E6%8A%80%E6%9C%AF%E5%AE%A1%E8%AF%84%E6%B2%9F%E9%80%9A%E4%BA%A4%E6%B5%81%E7%AE%A1%E7%90%86%E5%8A%9E%E6%B3%95%E3%80%8B%E7%9A%84%E9%80%9A%E5%91%8A%EF%BC%882020%E5%B9%B4%E7%AC%AC48%E5%8F%B7%EF%BC%89.pdf) - [20211222_CDE_关于沟通交流服务有关事宜的通知](/upload/20211222_CDE_%E5%85%B3%E4%BA%8E%E6%B2%9F%E9%80%9A%E4%BA%A4%E6%B5%81%E6%9C%8D%E5%8A%A1%E6%9C%89%E5%85%B3%E4%BA%8B%E5%AE%9C%E7%9A%84%E9%80%9A%E7%9F%A5.pdf) - 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