NMPA Announcement on the Technical Guideline for the Revision of Safety Information Items in Package Inserts of Marketed Traditional Chinese Medicines (Interim)
NMPA organized to formulate the Technical Guideline for the Revision of Safety Information Items in Package Inserts of Marketed Traditional Chinese Medicines (Interim), which was issued on January 4, 2022.
Notice of the Center for Drug Evaluation of NMPA on the Applicability of E2B (R3) Regional Implementation Guide to Individual Case Safety Reports during Drug Clinical Trials
In order to implement the E2B (R3) Regional Implementation Guide for Individual Case Safety Reports (hereinafter referred to as the Regional Implementation Guide), the Center for Drug Evaluation has completed the upgrade of the pharmacovigilance system during clinical trials, which was put into trial operation on January 1, 2022.
Notice of the Center for Drug Evaluation of NMPA on Issues related to the Implementation of ICH Guideline M9: Biopharmaceutics Classification System-Based Biowaivers and Q&A Document thereof
According to the NMPA Announcement, in order to well implement the ICH Guideline M9: Biopharmaceutics Classification System-Based Biowaivers and Q&A Document thereof (hereinafter referred to as M9 Guideline), upon the approval by National Medical Products Administration, the CDE is hereby notifying relevant issues as follows.
On December 29, NMPA held a working conference on the TCM quality and safety regulation to comprehensively summarize relevant work in 2021, deeply analyze current regulatory situation and matters, and deploy the priorities in 2022 to continuously enhance the TCM quality and safety regulation.
NMPA and Hainan Province Jointly Promoted the Pilot Application of Clinical Real-World Data of Drugs and Devices
On December 28, 2021, the NMPA and the Hainan Province jointly convened the third meeting of the leading group on the pilot application of clinical real-world data of drugs and devices in 2021.
The Plan calls for strengthening the overall coordination and leadership of drug safety, innovating and improving the support and guarantee mechanism, actively participating in global drug safety governance, and encouraging drug regulators to fulfill their duties and responsibilities.