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    Home > Medical News > Latest Medical News > State Food and Drug Administration: policy interpretation of the work plan for the reform of chemical drug registration and classification

    State Food and Drug Administration: policy interpretation of the work plan for the reform of chemical drug registration and classification

    • Last Update: 2019-04-23
    • Source: Internet
    • Author: User
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    1、 Can the application for class 2 registration of new chemical registration be exempted from new drug registration fee? New registration category 2 is improved new drug, and registration fee shall be paid as required 2、 For innovative drugs that have been exempted from clinical trial registration fees as required, is the supplementary application submitted during the clinical trial free of registration fees? Small and micro enterprises in line with the provisions of the State Council shall be exempted from the registration fee for innovative drugs that have been exempted from the registration fee according to the provisions, and the supplementary application submitted during the clinical trial shall be exempted from the registration fee 3、 It belongs to category 5.2 of new registration classification of chemicals, and conforms to the filing scope of announcement on the filing management of chemical bioequivalence test (No 257, 2015) How to handle the import filing formalities for be test samples and control drugs? The applicant shall file be test on the information platform of bioequivalence and clinical trial filing of chemical generic drugs After the filing is completed, the applicant shall go through the import filing formalities with the filing number to the port drug regulatory authority 4、 For radioactive drugs, narcotic drugs, class I psychotropic drugs, class II psychotropic drugs, drug precursor chemicals and cytotoxic drugs that belong to new registration classification 5.2 of chemical drugs, how to handle the import filing procedures for be test samples and control drugs? After self-assessment, the applicant can also record be test on the premise of ensuring the safety of the subjects After the record is completed, the applicant can go through the import record formalities with the record number at the port drug regulatory authority Among them, for narcotic drugs, class I psychotropic drugs and class II psychotropic drugs, an application shall be submitted to the State Drug Administration for the issuance of import license.
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