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NMPA Announcement on Further Strengthening the Administration of Radioactive Pharmaceuticals
2022-01-14
In order to further strengthen the manufacturing management of radioactive pharmaceuticals and ensure their quality, safety and effectiveness, in accordance with the Drug Administration Law, Provisions for the Administration of Radioactive Pharmaceuticals and other laws and regulations, the relevant issues are hereby announced as follows on January 13, 2022.
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NMPA Announcement on Issuing the Catalogue of Reference Preparations of Generic Drugs (Fiftieth Batch)
2022-01-11
On January 7, 2022, the NMPA issued the Catalogue of Reference Preparations of Generic Drugs (Fiftieth Batch), which has been reviewed and determined by the NMPA Experts Committee of Quality and Efficacy Consistency Evaluation of Generic Drugs.
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NMPA Announcement on Two Guidelines for Registration Review of Drug-Device Combination Products with Device Taking Primary Mode of Action
2022-01-17
National Medical Products Administration has set the technical evaluation of drug-device combination products as a research project in regulatory science, and organized to formulate the Guideline for Registration Review Drug-Device Combination Products with Device Taking Primary Mode of Action and the Guideline for Registration Review of Qualitative, Quantitative and In Vitro Release Studies of Drugs in Drug-Device Combination Products with Device Taking Primary Mode of Action.
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NMPA Announcement on the Technical Guideline for the Revision of Safety Information Items in Package Inserts of Marketed Traditional Chinese Medicines (Interim)
2022-01-07
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.
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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
2022-01-05
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.
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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.
