FDA新药申请指南.doc

FDA 新药许可申请、审核及管理简介在食品及药物管理局( 以下简称 FDA ) 管辖之内, 药物审评及研究中心( Center for Drug Evaluation and Research, 简称 CDER )专司新药之审核。该中心之下分成二室:新药物审评第一室( office of Drug Evaluation Ⅰ)新药物审评第二室( office of Drug Evaluation Ⅱ)。新药审评第一室管辖五个药物科, 新药审评第二室则管三个药物科,在这八个药物科内,每一科约有 30~ 5O 名专门人员负责各项新药审评工作, 整个药物审评及研究中心是一个庞大的组织, 而新药申请及审评整个过程繁杂, 必须逐步进行。药物审评及研究中心( Center for Drug Evalution and Research , CDER ) 之组织说明如下: 1 .秘书室( Executive Secretariant Staff ) 2 .总务室( Office of Management ) (l )药物资记中心( Drug Information Resource ) (2 )医学图书馆( Medical Library ) (3 )总务及王计( Management and Budget ) (4 )资讯系统设计( Information System Design ) 3 .专业进修室( Professional Development ) 4 .顾问团( Advisors and Consultants Staff ) 5· 前导性新药审评( Pilot Drug Evaluation ) 6 .非处方药审评室( office of OTC Drug Evaluation ) (1 )单篇非处方药审评室( MonograPh Review Staff ) (2 )非处方药政策性科( OTC Drug Policy Staff ) (3 )医学审评科( Medical Review Staff ) 7 .非专利处方药室( office of Generic Drugs ) (1 )化学第一科( Chemistry Ⅰ) (2 )化学第二科( Chemistry Ⅱ) (3 )生体相等性科( Bioequivalence ) 8 .研究发展室( Office of Research Resources ) (1 )研究及试验科( Research and Testing ) (2 )药品分析科( Drug Analysis ) (3 )生体药学科( Biopharmaceutics ) (4) 临床药理科( Clinical pharmacology ) 9 .新药标准室( Office of Drug Standards ) (l) 新药市场广告及信息科( Drug Marketing , Advertising munications ) 10 .新药合法性室( Office pliance ) (1 )新药信息科( Drug pliance ) (2 )新药品质审核科( Drug Quality Evaluation ) (3 )新药产品及制造品质科( Mahufacturing and Product Quality ) (4 )科学性