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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
2021-12-31
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.
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NMPA held a working conference on the TCM quality and safety regulation
2021-12-31
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.
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NMPA and Hainan Province Jointly Promoted the Pilot Application of Clinical Real-World Data of Drugs and Devices
2021-12-28
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.
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Issuance of the 14th Five-Year Plan for National Drug Safety and High-Quality Development
2021-12-30
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.
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NMPA Announcement on the Revision of the Package Insert of the Vitamin B6 Injection
2021-07-27
In accordance with the results of adverse drug reaction evaluation, to further protect drug safety for the people, NMPA decided to modify the items of [Adverse reactions] and [Contraindications] in the package inserts of Vitamin B6 injection.
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NMPA Announcement on Issuing the Catalogue of Reference Preparations of Generic Drugs (Forty-three Batch)
2021-07-23
On July 22, the Catalogue of Reference Preparations of Generic Drugs (Fortythree Batch) was issued, upon review and determination by the NMPA Experts Committee of Quality and Efficacy Consistency Evaluation of Generic Drugs.
