NMPA Announcement on Issuing the Catalogue of Reference Preparations of Generic Drugs (Thirty-eighth Batch)
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.
NMPA Notice on Issuing the Requirements for Change Items of Marketed Chemicals and Application Dossier
To cooperate with the implementation of the Provisions for Drug Registration, the NMPA has organized to formulate the Requirements for Change Items of Marketed Chemicals and Application Dossier.
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.
NMPA Announcement on Approval of Adding the Filing Function for the First Importation of Chemicals to the Chongqing Municipal Medical Products Administration
The NMPA has approved the application of the Chongqing Municipal Medical Products Administration for adding the filing function for the first importation of chemicals, and this Announcement was hereby issued on February 2 as follows.
According to the Provisions for the Classification Management of Prescription and Non-prescription Drugs (Interim), after the demonstration and review organized by the NMPA, the Weian Capsules are approved to be regulated as non-prescription drugs.
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.