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    Home > Medical News > Latest Medical News > CDE: 29 generic drug reference preparation varieties have not passed the review

    CDE: 29 generic drug reference preparation varieties have not passed the review

    • Last Update: 2021-08-14
    • Source: Internet
    • Author: User
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    Medical Network, August 5 News On August 3, the Drug Evaluation Center of the State Food and Drug Administration issued a notice on the public solicitation of "Chemical Generic Drug Reference Preparation Catalog (47 batch)" (draft for solicitation of comments)
    .
    According to the notification documents, a total of 15 reference preparations have been added this time, 30 generic reference preparations have been released, and 29 generic reference preparations have not passed the review
    .
     
    The original text is as follows:
     
    Notice on Publicly Soliciting Opinions on the "List of Reference Preparations of Chemical Generic Drugs (Forty-seventh Batch)" (Draft for Solicitation of Comments)
     
    According to the "Announcement on the Selection and Determination Procedures for the Publication of Chemical Generic Drug Reference Preparations" issued by the National Bureau on March 28, 2019 (No.
    25, 2019), our center organized the selection of the 47th batch of reference preparations (see Attachment), it is now publicly available for comments
    .
     
    During the period of publicity, please provide feedback to the Drug Evaluation Center through the "Suspicious Variety Application for Reference Preparation" module under the reference preparation selection application platform.
    In order to better serve the applicant, please provide sufficient basis and demonstration materials for feedback, and the feedback materials should be stamped The official seal of the unit, and the real name and contact information should be provided
    .
     
    Announcement period: August 3, 2021 to August 16, 2021 (10 working days)
    .
     
      Annex 1 The list of reference preparations for chemical generic drugs has not yet been released (forty-seventh batch) (draft for comments)
     
      Appendix 2 Supplementary Catalogue of Reference Preparations of Chemical Generic Drugs Published (Draft for Solicitation of Comments)
     
      Annex 3 List of Species that have not passed the review
      Medical Network, August 5 News On August 3, the Drug Evaluation Center of the State Food and Drug Administration issued a notice on the public solicitation of "Chemical Generic Drug Reference Preparation Catalog (47 batch)" (draft for solicitation of comments)
    .
    According to the notification documents, a total of 15 reference preparations have been added this time, 30 generic reference preparations have been released, and 29 generic reference preparations have not passed the review
    .
     
      The original text is as follows:
     
      Notice on Publicly Soliciting Opinions on the "List of Reference Preparations of Chemical Generic Drugs (Forty-seventh Batch)" (Draft for Solicitation of Comments)
     
      According to the "Announcement on the Selection and Determination Procedures for the Publication of Chemical Generic Drug Reference Preparations" issued by the National Bureau on March 28, 2019 (No.
    25, 2019), our center organized the selection of the 47th batch of reference preparations (see Attachment), it is now publicly available for comments
    .
     
      During the period of publicity, please provide feedback to the Drug Evaluation Center through the "Suspicious Variety Application for Reference Preparation" module under the reference preparation selection application platform.
    In order to better serve the applicant, please provide sufficient basis and demonstration materials for feedback, and the feedback materials should be stamped The official seal of the unit, and the real name and contact information should be provided
    .
     
      Announcement period: August 3, 2021 to August 16, 2021 (10 working days)
    .
     
      Annex 1 The list of reference preparations for chemical generic drugs has not yet been released (forty-seventh batch) (draft for comments)
     
      Appendix 2 Supplementary Catalogue of Reference Preparations of Chemical Generic Drugs Published (Draft for Solicitation of Comments)
     
      Annex 3 List of Species that have not passed the review
      Medical Network, August 5 News On August 3, the Drug Evaluation Center of the State Food and Drug Administration issued a notice on the public solicitation of "Chemical Generic Drug Reference Preparation Catalog (47 batch)" (draft for solicitation of comments)
    .
    According to the notification documents, a total of 15 reference preparations have been added this time, 30 generic reference preparations have been released, and 29 generic reference preparations have not passed the review
    .
     
      The original text is as follows:
     
      Notice on Publicly Soliciting Opinions on the "List of Reference Preparations of Chemical Generic Drugs (Forty-seventh Batch)" (Draft for Solicitation of Comments)
     
      According to the "Announcement on the Selection and Determination Procedures for the Publication of Chemical Generic Drug Reference Preparations" issued by the National Bureau on March 28, 2019 (No.
    25, 2019), our center organized the selection of the 47th batch of reference preparations (see Attachment), it is now publicly available for comments
    .
     
      During the period of publicity, please provide feedback to the Drug Evaluation Center through the "Suspicious Variety Application for Reference Preparation" module under the reference preparation selection application platform.
    In order to better serve the applicant, please provide sufficient basis and demonstration materials for feedback, and the feedback materials should be stamped The official seal of the unit, and the real name and contact information should be provided
    .
     
      Announcement period: August 3, 2021 to August 16, 2021 (10 working days)
    .
     
      Annex 1 The list of reference preparations for chemical generic drugs has not yet been released (forty-seventh batch) (draft for comments)
     
      Appendix 2 Supplementary Catalogue of Reference Preparations of Chemical Generic Drugs Published (Draft for Solicitation of Comments)
     
      Annex 3 List of Species that have not passed the review
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