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    Home > Active Ingredient News > Drugs Articles > Circular of the State Administration on Issuing the requirements for application materials of pharmaceutical excipients for drug packaging materials (Trial) (2016 No. 155)

    Circular of the State Administration on Issuing the requirements for application materials of pharmaceutical excipients for drug packaging materials (Trial) (2016 No. 155)

    • Last Update: 2016-11-29
    • Source: Internet
    • Author: User
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    Source: CFDA 2016-11-29 in accordance with the announcement on matters related to the review and approval of pharmaceutical excipients and drugs for drug packaging materials (No 134, 2016, State Food and Drug Administration) No.), our bureau has organized and formulated the application data requirements for drug packaging materials (for Trial Implementation) and application data requirements for pharmaceutical excipients (for Trial Implementation), which are hereby promulgated, and the relevant matters are notified as follows: I if the drug packaging materials and pharmaceutical excipients have been declared in connection with the drug clinical trial application, if there is any change in the drug listing application stage, the drug packaging materials and pharmaceutical excipients production enterprise shall timely notify the drug registration applicant, and directly submit the relevant supplementary information to the drug evaluation center of the State Food and drug administration, with the acceptance notice of drug packaging materials and pharmaceutical excipients attached, There is no need to repeat the related declaration II In case of any change in the name, production address, prescription process, quality standard, etc of the manufacturer of drug packaging materials and pharmaceutical auxiliary materials, the manufacturer shall carry out research and timely notify the relevant drug manufacturer Drug manufacturers shall timely master the change of drug packaging materials and pharmaceutical excipients, and conduct research and evaluation according to the relevant technical guidelines For the change of drug packaging materials and pharmaceutical excipients that affect the quality of drugs, they shall apply for drug supplement according to the relevant provisions of the measures for the administration of drug registration For the change of drug packaging materials and pharmaceutical excipients that do not affect the quality of drugs, they shall apply for drug registration management Item 36 of the supplementary application in Annex 4 of the measures shall be filed with the provincial food and drug regulatory authorities 3 If the applicant for drug registration submits the research data of drug packaging materials and pharmaceutical excipients together with the application data of drug registration, the drug review can be carried out, and the approval number of drug packaging materials and pharmaceutical excipients will not be issued after the review 4 This Circular shall go into effect as of the date of promulgation Notice is hereby given Annex: 1 Requirements for application materials of drug packaging materials (Trial) 2 Requirements for application materials of pharmaceutical excipients (Trial) 3 Application form for development of drug packaging materials and pharmaceutical excipients 4 Report form for on-site inspection of drug packaging materials and pharmaceutical excipients 1 Docx of Circular No 155 of food and drug administration of the people's Republic of China on November 23, 2016 Annex 2 to circular 155 of 2016 Doc Annex 3 to circular 155 of 2016 Doc Annex 4 to circular 155 of 2016 Doc
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