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New guidelines issued by China NMPA on Thanksgiving day regarding RWD/overseas clinical data

  • 1.  New guidelines issued by China NMPA on Thanksgiving day regarding RWD/overseas clinical data

    Posted 27-Nov-2020 10:59
    On US Thanksgiving day, 2 gifts from China NMPA (CFDA) to help overseas manufacturers:
    1. "Technical Guideline on Real World Data (RWD) Used in Medical Device Clinical Evaluation (Trial Implementation)" (No. 77 of 2020)   
    2. "Technical guideline for overseas clinical trial data usage in vitro diagnostic reagents (draft for comments)".
    Both guidelines are progressing towards international harmonization and  help overseas manufacturers to reduce burdens of China local clinical trials for medical devices and IVDs. 

    If you would like to understand how these guidelines and Hainan program can accelerate your product launches for China unapproved devices, please check out this RAPS webcast: Event Details | RAPS
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    Event Details | RAPS
    View this on Raps >


    Please let me know if your experiences in using "urgent" use approval and real-world data experience in China.  We have experienced successes where clinical trials are avoided in China with overseas clinical trial data justification or supplemented by a small size to address the ethnic difference gap.

    ------------------------------
    Grace Fu Palma
    ChinaMed Device, LLC
    MA, U.S.
    gpalma@ChinaMedDevice.com
    978-390-4453
    www.ChinaMedDevice.com
    ------------------------------


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