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Ainuovirine, Lamivudine and Tenofovir Disoproxil Fumarate Tablets approved for marketing
2023-01-04
Recently, the innovative drug Ainuovirine, Lamivudine and Tenofovir Disoproxil Fumarate Tablets (trade name:复邦德) of Jiangsu Aidea Pharmaceutical Co., Ltd. is approved by China NMPA.
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Importation of MSD's Molnupiravir Capsules approved with condition
2022-12-30
The importation registration of Molnupiravir Capsules (trade name: 利卓瑞/LAGEVRIO) for the treatment of COVID-19 of MSD Inc. is approved with condition for marketing by China NMPA on December 29, through emergency review and approval procedure in accordance with the relevant provisions of special review and approval prescribed in the Drug Administration Law.
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Provisions for Supervision and Administration of Online Drug Sales
2022-12-29
The Provisions for Supervision and Administration of Online Drug Sales is promulgated by Decree No. 58 of the State Administration for Market Regulation on August 3, 2022 and shall be effective as of December 1, 2022.
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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.
