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NMPA Announcement on Approval of Adding the Filing Function for the First Importation of Chemicals to the Chongqing Municipal Medical Products Administration
2021-02-07
The NMPA has approved the application of the Chongqing Municipal Medical Products Administration for adding the filing function for the first importation of chemicals, and this Announcement was hereby issued on February 2 as follows.
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NMPA Announcement on Cancellation of 8 Certification Items
2021-02-05
As per the Notice of the General Office of the State Council on Effective Clearance of Certification Items, to further reduce redundant certification for the convenience of the people and optimize governmental service, the NMPA decided to cancel 8 certification items.
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NMPA Announcement on Regulating Weian Capsules as Non-prescription Drugs
2021-02-01
According to the Provisions for the Classification Management of Prescription and Non-prescription Drugs (Interim), after the demonstration and review organized by the NMPA, the Weian Capsules are approved to be regulated as non-prescription drugs.
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NMPA Notice on Issuing the Guidance for Technical Review of Clinical Evaluation of Equivalent Devices of Medical Magnetic Resonance Imaging Systems (Revision 2020)
2021-02-01
The NMPA organized to formulate the Guidance (Revision 2020) for Technical Review of Clinical Evaluation of Equivalent Devices of Medical Magnetic Resonance Imaging Systems which was issued on January 27, 2021.
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NMPA Announcement on Adopting ICH Guideline E9 (R1)
2021-01-25
To keep pace with the international technical standards for drug registration, the NMPA has decided to adopt the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) Guideline E9 (R1): Addendum on Estimands and Sensitivity Analysis in Clinical Trials.
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NMPA Announcement on Adopting ICH Guidelines S5 (R3) and S11
2021-01-25
To keep pace with the international technical standards for drug registration, the NMPA has decided to adopt two guidelines of ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use).