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NMPA Announcement on the Application of ICH Guideline E9 (R1): Estimands and Sensitivity Analysis in Clinical Trials
2021-01-21
To keep pace with the international technical standards for drug registration, the NMPA has decided to recommend the application of ICH Guideline E9 (R1): Estimands and Sensitivity Analysis in Clinical Trials.
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NMPA Announcement on Issuing Three Guidelines for Technical Review of the Registration Including that of Mycoplasma Pneumoniae IgM/IgG Antibody Detection Reagents
2021-01-19
NMPA has organized the formulation of and released on January 18, 2021 Three Guidelines for Technical Review of the Registration including that of Mycoplasma Pneumoniae IgM/IgG Antibody Detection Reagents.
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NMPA Announcement on Issuing of Two Registration Technical Review Guidelines Including the Guidelines for Technical Review of Clinical Evaluation of Ultrasound Diagnostic Imaging Equipment Based on Predicate Products
2021-01-18
The NMPA has organized to formulate 2 technical review guidelines for registration including the Guidelines for Technical Review of Clinical Evaluation of Ultrasound Diagnostic Imaging Equipment Based on Predicate Products.
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NMPA Announcement on Revising the Package Inserts of Sulfasalazine Preparations
2021-01-14
To further protect public medication safety, the NMPA decided to revise the package inserts of Sulfasalazine Preparations. The relevant issues are hereby announced as follows.
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NMPA Announcement on Issuing the Provisions for the Change Management of Post-approval Drugs (Interim)
2021-01-13
The NMPA organized to formulate of the Provisions for Change Management of Post-approval Drugs (Interim), is hereby promulgated and shall go into effect as of January 12, 2021.
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SAMR Issued the Provisions for Registration and Notification of Cosmetics
2021-01-12
The NMPA drafted the Provisions for Registration and Notification of Cosmetics (hereinafter referred to as the Provisions). The Provisions has been adopted upon deliberation at the 14th Executive Meeting of the State Administration of Market Regulation on December 31, 2020, and shall go into effect as of May 1, 2021.