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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).
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NMPA Announcement on Issuing the Catalogue of Medical Devices Exempt from Clinical Trials (Revised Second Batch)
2021-01-19
NMPA issued the Announcement on the Issuance of the New and Revised Catalogues of Medical Devices Exempt from Clinical Trials, and published the first batch of New and Revised Catalogues of Medical Devices (and in vitro diagnostic reagents) Exempt from Clinical Trials.
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NMPA Announcement on the Cancellation of Registration Certificates for Phenolphthalein Tablets and Phenolphthalein Buccal Tablets
2021-01-14
The NMPA therefore decided the immediate cessation of production, sales and use of the two drugs in China with their registration certificates (drug approval number) revoked forthright.
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Clinical Technical Requirements for Drugs Marketed Overseas but Not Marketed in China
2020-11-18
CDE issued the Clinical Technical Requirements for Drugs Marketed Overseas but Not Marketed in China on October 9, 2020.
