Regulatory Dynamics

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  Medical Policies Weekly

  The National Medical Products Administration released the 44th batch of generic drug reference preparation catalog

  2021-08-23
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  Medical Policies Weekly

  The Center for Drug Evaluation issued the "Technical Guidelines for Clinical Trials of Drugs for the Treatment of Acute Non-Varicose Upper Gastrointestinal Bleeding"

  2021-08-09
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  Medical Policies Weekly

  "Chinese Medicine, Chemical Medicine and Biological Products Production Process, General Format for Quality Standard and Writing Guide"

  2021-07-27
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  Medical Policies Weekly

  CDE issued a number of drafts for comments
  Recently, CDE has issued a number of drafts for comments, including:
  

  2021-07-12
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  Medical Policies Weekly

  1.NMPA released the 42nd batch of list of generic drug reference preparations
  On June 25, after review and determination by the Expert Committee of the Quality and Efficacy Consistency Evaluation of Generic Drugs of NMPA, NMPA formally released the "List of Generic Drug Reference Preparations (42nd Batch)".
  

  2021-06-28
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  National Medical Products Administration issued the "Drug Inspection Management Measures (Trial)"

  In order to implement the "Drug Administration Law" and "Vaccine Administration Law", further standardize drug inspection behavior, and promote drug supervision work to adapt to the new situation as soon as possible, NMPA has organized and formulated the "Drug Inspection Management Measures (Trial)" (hereinafter referred to as the "Measures”) and will be issued on May 28. The relevant matters are notified as follows:

  2021-05-31