原料药通过fda批准的两个阶段及基本程序（Two stages and basic procedures for the approval of API through FDA）.docVIP

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原料药通过fda批准的两个阶段及基本程序（Two stages and basic procedures for the approval of API through FDA）.doc

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原料药通过fda批准的两个阶段及基本程序（Two stages and basic procedures for the approval of API through FDA）

原料药通过fda批准的两个阶段及基本程序（Two stages and basic procedures for the approval of API through FDA） Two stages and basic procedures for the approval of API through FDA Author: anonymous source: the international pharmaceutical original hits: 133 update time: 2003-11-26 [keyword]:DMF file, FDA Health net: According to federal regulations (Code of Federal Regula tion) the relevant provisions of the 210th and in section 211, any access to the U.S. market of drugs (including raw drugs) are first approved by the FDA, and all related to drug production and processing, packaging shall be in strict accordance with the requirements of cGMP in the United states. For APIs, approved by the FDA has two stages, one is the DMF file of the registration, production and quality management of the application of drugs required to submit the DMF documents and the whole process of drug quality itself to do a detailed description. FDA is confidential for this document, which is reviewed by the FDA drug evaluation and Research Center (Center for Drug Evaluation and Research, CDER). The two is when the DMF file registration has been completed, and pharmaceutical raw materials terminal users in the United States put forward the application, FDA officials on raw material manufacturers GMP drug compliance through on-site inspection, a comprehensive study of the production management and quality management in the whole process of drug production, make the production and quality management of the raw material production enterprises the medicine can ensure the quality of the drugs produced the judgment. On the basis of on-site inspections, FDA made a decision on whether to approve the listing of the raw material in the US market. To this end, FDA has published many guidance documents, including the guide, archives management of drug application for drug production and drug raw materials document production inspection guide, to guide the production of drug manufacturers listing application documents and rea