美国仿制药申报程序.pdf

Abbreviated New Drug Application Process/仿制药的简略新药申请程序 制药的简略新药申请程序（ANDA Process） 前言 简略新药申请的指南文件 法律，法规，政策和程序 o 美国联邦法典 o 政策和程序手册 ANDA 表格和电子申请 药品开发和评审定义 药品开发方面的常见问题 相关主题 前 言 An Abbrev iated New Drug Application (ANDA) contains data which when submitted to FDAs Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the rev iew and ultimate approval of a generic drug product. 简略新药申请（ANDA）所包 括的资料被交至FDA 药品评审和研究中心所属的仿制药办公室，用于仿制药的评审和最 终批准。Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.一旦批准， 则申请者可以生产和销售该仿制药以向美国公众提供安全，有效，廉价的替代品。 A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use. 仿制药在剂型，剂量，服用方式，质量，性能特征和用途方法都是和原创药物相当 的。All approved products, both innovator and generic, are listed in FDAs Approved Drug Products with Therapeutic Equivalence Evaluations ( Orange Book). 所 被批准的药 品，包括原创药和仿制药都列在FDA 的 有相当疗效评估的已批准药品（橙皮书）上。 Generic drug applications are termed abbreviated because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. 仿制药申请被称为“简略申请”，是因为它们基本上不需要临床前资料（动 物实验）和临床资料（人体实验）来建立安全性的有效性。Instead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner as the innovator drug). 仿制药申请者必须要科学地 论述他们的产品是生物等 效的（也就是，和原创药同样的性能表现）One way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream in 24 to 36 healthy, volunteers. 科学家论证生物等效性的一种方法就是测定仿制药到达24￣36 位健 康志愿者血流中的时间。This gives them the rate of absorption, or bioavailability, of the generic drug, which