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    Home > Medical News > Latest Medical News > Just now! Evaluation standard for the first import port of drugs issued by the State Food and Drug Administration

    Just now! Evaluation standard for the first import port of drugs issued by the State Food and Drug Administration

    • Last Update: 2020-01-03
    • Source: Internet
    • Author: User
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    Drug supervision and administration departments at all ports (border ports): According to the notice of the general office of the general office of the general office of the food and Drug Administration and the general office of the general office of the Customs on printing and distributing the evaluation scheme for the work of adding the permitted drug import ports (SFDA [2015] No 134), the notice of the general Office of the food and Drug Administration on printing and distributing the implementation scheme for the work of adding the permitted drug import ports (SFDA [2016] No 150) )In accordance with relevant regulations, the State Drug Administration has organized the drafting of the first port evaluation standard for drug import, which is hereby printed and distributed The port drug administration may, according to the demand for drug import, apply to the SDA for the first port of drug import Assessment standard for the first drug import port of the comprehensive Department of the State Food and Drug Administration on December 30, 2019 1 The application for adding the first drug import port (excluding medicinal materials) should match the demand If free trade zone has been set up in the region or biomedical industrial park has been set up by local government, and there is a clear plan involving biomedical industry, and biomedical enterprises in the region put forward clear demand for the first drug import 2、 The port drug inspection agency applying for the first drug import shall have at least 3 domestic and foreign experts who can understand and master the latest foreign drug technical standards (such as World Health Organization, USP, European EDQM experts, members of domestic Pharmacopoeia Committee, international GMP inspectors, etc.) 3、 The port drug inspection institution applying for the first import of drugs shall have the research experience of relevant scientific research projects of national standards Have research experience in international drug standards (foreign Pharmacopoeia standards) and at least 50 domestic drug standards (including national pharmacopoeia standards and national drug registration standards) 4、 In the past three years, the port drug inspection agency applying for the first drug import has participated in the capacity verification and comparison test organized by the domestic authoritative agencies (China National Accreditation Commission for conformity assessment, China food and drug inspection and Research Institute, etc.) at least 10 times, and participated in the capacity organized by the international authoritative agencies (World Health Organization, International Pharmaceutical Federation, European drug quality administration, etc.) Verification tests shall be carried out at least twice and shall be of satisfactory grade 5、 The inspection and testing capacity of the port drug inspection institution applying for the first time of drug import shall meet the requirements of drug port inspection, and have the ability to cover all items in the Pharmacopoeia standards at home and abroad In the past five years, the number of domestic and foreign standards involved in all kinds of drug inspection tasks shall not be less than 100, of which the number of imported drug standards shall not be less than 30 (including port inspection, supervision sampling inspection and drug standard review) 6、 The port drug inspection institution applying for the first import of drugs shall have independent scientific research capacity, and the institution shall have undertaken the research work of relevant scientific research projects at or above the provincial and ministerial level 37
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