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    Home > Medical News > Latest Medical News > The CDE issued a notice on the "Changes in the Working Procedures during the Review of Drug Registration Applications (Trial)"

    The CDE issued a notice on the "Changes in the Working Procedures during the Review of Drug Registration Applications (Trial)"

    • Last Update: 2022-11-26
    • Source: Internet
    • Author: User
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    Notice of the Center for Drug Review of the State Food and Drug Administration on the issuance of the "Work Procedures for Changes during the Review of Drug Registration Applications (Trial)" (Drug Review Industry [2022] No.
    597)
    Release date: 20221111

    In order to cooperate with the implementation of the Measures for the Administration of Drug Registration, further standardize the changes during the review of drug registration applications, and ensure the safety, effectiveness and quality control of drugs, the Center for Drug Review has organized and formulated the "Working Procedures for Changes during the Review of Drug Registration Applications (Trial)" (see Annex), which is hereby issued after the review and consent of the State Medical Products Administration and will be implemented
    from the date of promulgation.

    Annex: Changes to the Working Procedures During the Review of Drug Registration Applications (Trial)

    Drug Review Center, State Food and Drug Administration

    November 9, 2022

    Related attachments

    serial number Attachment name
    1 .
    pdf the working procedures for changing during the review of drug registration applications
    2 .
    doc confirmation of change of drug registration applicant
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