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NMPA Notice on Issuing the Requirements for Change Items of Marketed Traditional Chinese Medicines and Application Dossiers
2021-02-24
The NMPA has organized to formulate the Requirements for Change Items of Marketed Traditional Chinese Medicines and Application Dossiers, which has been issued and implemented on February 23.
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NMPA Announcement on Issuing the Catalogue of Reference Preparations of Generic Drugs (Thirty-eighth Batch)
2021-02-23
On February 20, the Catalogue of Reference Preparations of Generic Drugs (Thirty-eighth Batch) was issued, upon review and determination by the NMPA Experts Committee of Quality and Efficacy Consistency Evaluation of Generic Drugs.
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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.