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).
NMPA Announcement on the Application of ICH Guideline E9 (R1): Estimands and Sensitivity Analysis in Clinical Trials
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.
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.
NMPA Announcement on the Cancellation of Registration Certificates for Phenolphthalein Tablets and Phenolphthalein Buccal Tablets
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.
NMPA Announcement on Issuing the Provisions for the Change Management of Post-approval Drugs (Interim)
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.
The NMPA has enabled and officially launched on January 1, 2021 the online application module for drug registration affairs.