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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.
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NMPA Notice on Launching the Cosmetic Ingredient Safety Information Registration Platform
2021-12-30
In order to implement the Provisions for the Registration and Filing of Cosmetics, Provisions for the Registration or Filing Dossier of Cosmetics and other regulatory documents, NMPA organized to establish the Cosmetic Ingredient Safety Information Registration Platform.
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NMPA Announcement on Trial Operation of Electronic Registration Certificate for Cosmetics
2021-12-27
It has been decided upon study that electronic registration certificate for cosmetics will start trial operation since January 1, 2022. Relevant issues are hereby announced as follows.
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NMPA CDE Announcement on Issuing the Guidance for the Preparation of Application Dossiers for TCM Theory of Compound Preparations of New Chinese Medicines (interim) and the Guidance for the Preparation of the Package Inserts of Compound Preparations of Chinese Medicines in Ancient Classic Prescriptions (interim)
2021-10-15
The CDE has organized to formulate the Guidance for the Preparation of Application Dossiers for TCM Theory of Compound Preparations of New Chinese Medicines (interim) and the Guidance for the Preparation of the Package Inserts of Compound Preparations of Chinese Medicines in Ancient Classic Prescriptions (interim).
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NMPA CDE Announcement on Issuing the Technical Guidance for Clinical Trials of Anti-HIV Infectious Drugs
2021-10-13
The CDE has formulated the Technical Guidance for Clinical Trials of Anti-HIV Infectious Drugs, which was issued and implemented on October 12, 2021 upon the review and approval by the National Medical Products Administration.
