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NMPA Announcement on Revising the Package Insert of Methimazole Preparations
2021-02-09
To further protect public medication safety, the NMPA decided to revise the package insert of Methimazole Preparations. The relevant issues are hereby announced as follows.
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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.