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    Home > Active Ingredient News > Drugs Articles > Circular of the State Council on matters related to the charging standards for new registration and classification of chemicals (No. 124, 2016)

    Circular of the State Council on matters related to the charging standards for new registration and classification of chemicals (No. 124, 2016)

    • Last Update: 2016-09-02
    • Source: Internet
    • Author: User
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    Source: CFDA 2016-9-2 November 4, 2015 Decision on Authorizing the State Council to carry out pilot drug listing license holder system in some places and relevant issues, and announcement on Issuing the working plan of chemical drug registration and classification reform (No 51, 2016, hereinafter referred to as "SFDA") adopted at the 17th meeting of the Standing Committee of the 12th National People's Congress Announcement No 51, 2016), which reclassified chemicals, and now it is announced as follows: 1 Application for registration of chemicals with new registration classification of 1 and 2 categories, in accordance with the announcement on issuing registration charging standards for drugs and medical devices (2015, State Food and Drug Administration) No 53 (hereinafter referred to as Announcement No 53 of 2015) is charged according to the standard of registration fee for new drugs; for the registration application of chemicals with new registration classification of 3 and 4 categories, the fee shall be charged according to the standard of registration fee for generic drugs in Announcement No 53 of 2015 Among them, if the production enterprise is located in China, it will be charged according to the registration fee standard of Chinese products published in Announcement No 53 of 2015; if the production enterprise is located abroad, it will be charged according to the import registration fee standard published in Announcement No 53 of 2015 2、 For the registration application of chemicals with new registration classification of 5 categories, fees shall be charged according to the production / listing fee standard for imported drugs without clinical trial and production / listing fee for imported drugs requiring clinical trial in Announcement No 53, 2015 3、 After the promulgation and implementation of announcement 51 in 2016 and before the promulgation and implementation of this circular, if the applicable charging standards in the notice of payment for administrative licensing projects accepted according to the new registration classification are inconsistent with this circular, the applicant shall apply to the original accepting department for refund or supplementary payment of relevant fees before October 30, 2016 The materials to be submitted by the applicant include: (1) application for refund or supplementary payment; (2) bank remittance document (copy); (3) general payment document for non tax income (copy to be provided when applying for supplementary payment and original to be provided when applying for refund); (4) application form for drug registration (copy); (5) Acceptance notice (copy) 4、 If the application for review and approval according to the new registration classification has been accepted before the implementation of Announcement No 51 in 2016, the applicant shall apply to the original acceptance department for making up the relevant fees The review and approval of the corresponding registration application shall be suspended before the applicant pays the relevant fees The materials to be submitted by the applicant include: (1) application for supplementary payment; (2) bank remittance document (copy); (3) general payment document for non tax income (copy); (4) application form for drug registration (copy); (5) acceptance notice (copy) Notice is hereby given Food and Drug Administration August 23, 2016
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