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The Food and Drug Administration issued a public notice for the approval of the review and approval of clinical trials for drug adjustments (draft for comments)

The Food and Drug Administration issued a public notice for the approval of the review and approval of clinical trials for drug adjustments (draft for comments)

  • Categories:Industry news
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  • Time of issue:2019-06-18 17:40
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(Summary description)In order to implement the requirements of the General Office of the CPC Central Committee and the General Office of the State Council on the Opinions on Deepening the Reform of the Examination and Approval System and Encouraging the Innovation of Pharmaceutical Devices, the Food and Drug Administration has drafted the “Notice on Adjusting the Examination and Approval of Clinical Trials for Drugs” (Consultation Draft) ), is now open for comments and suggestions.

The Food and Drug Administration issued a public notice for the approval of the review and approval of clinical trials for drug adjustments (draft for comments)

(Summary description)In order to implement the requirements of the General Office of the CPC Central Committee and the General Office of the State Council on the Opinions on Deepening the Reform of the Examination and Approval System and Encouraging the Innovation of Pharmaceutical Devices, the Food and Drug Administration has drafted the “Notice on Adjusting the Examination and Approval of Clinical Trials for Drugs” (Consultation Draft) ), is now open for comments and suggestions.

  • Categories:Industry news
  • Author:
  • Origin:
  • Time of issue:2019-06-18 17:40
  • Views:
Information
In order to implement the requirements of the General Office of the CPC Central Committee and the General Office of the State Council on the Opinions on Deepening the Reform of the Examination and Approval System and Encouraging the Innovation of Pharmaceutical Devices, the Food and Drug Administration has drafted the “Notice on Adjusting the Examination and Approval of Clinical Trials for Drugs” (Consultation Draft) ), is now open for comments and suggestions.
 
The relevant units and individuals are requested to provide feedback by email before January 14, 2018.
 
In order to encourage innovation, accelerate the creation of new drugs, and meet the needs of the public for drug use, according to the Opinions of the General Office of the CPC Central Committee and the General Office of the State Council on Deepening the Reform of Examination and Approval System to Encourage Drug Device Innovation (Junzi [2017] No. 42), optimize drug clinical The trial review and approval, drawing on international experience, make adjustments to the procedures and methods for clinical trial review and approval.

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