化学药品创新药上市申请前会议药学共性问题相关技术要求(征求意见稿)

2021-07-02 国家药品监督管理局药品审评中心(CDE) CDE

为鼓励创新药研发和申报,提高申请人和监管机构沟通交流的质量与效率,加快创新药上市进程,我中心组织制订了《化学药品创新药上市申请前会议药学共性问题相关技术要求(征求意见稿)》。

中文标题:

化学药品创新药上市申请前会议药学共性问题相关技术要求(征求意见稿)

发布日期:

2021-07-02

简要介绍:

为鼓励创新药研发和申报,提高申请人和监管机构沟通交流的质量与效率,加快创新药上市进程,我中心组织制订了《化学药品创新药上市申请前会议药学共性问题相关技术要求(征求意见稿)》。
       我们诚挚地欢迎社会各界对征求意见稿提出宝贵意见和建议,并及时反馈给我们,以便后续完善。征求意见时限为自发布之日起一个月。
       您的反馈意见请发到以下联系人的邮箱:
       联系人:王亚静、牛寒冬
       联系方式:wangyajing@cde.org.cn、niuhd@cde.org.cn
       感谢您的参与和大力支持。
                                                                                                                           国家药品监督管理局药品审评中心
                                                                                                                                         2021年7月2日

相关资料下载:
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66.pdf
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#插入话题
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    2021-07-08 ms3000001999514966

    理学药物

    0

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    2021-07-06 ms3000001999514966

    理学主题

    0

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    2021-07-05 iris6898

    确实有很多问题

    0

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    2021-07-05 ms3882304424310386

    需要时用

    0

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    2021-07-05 ms8000001471478848

    学习了

    0