Regulatory Open Forum

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  • 1.  China

    This message was posted by a user wishing to remain anonymous
    Posted 28-Jul-2020 15:09
    This message was posted by a user wishing to remain anonymous

    Good afternoon all,

    What is a very good source or web site for finding information on China regulatory submission pathways?  

    I have been on the CDE website and found policy changes and some guidelines.  However, the guidelines are not as descriptive on requirements etc.

    Thank you in advance for all your help.

    Kind Regards,

    Angela



  • 2.  RE: China

    Posted 29-Jul-2020 03:32
    Dear Angela

    ClinRegs may fit the bill. It even has a side by side of US vs China regulations: https://clinregs.niaid.nih.gov/country/china/united-states#scope_of_assessment.

    Regards
    Hamish

    ------------------------------
    Hamish King JD
    Director Business Development
    Hong Kong
    Hong Kong
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    Original Message


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