仿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 Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review 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 FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).所有被批准的药品，包括原创药和仿制药都列在FDA的具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 they can then compare to that of the innovator drug. 这个实验给出仿制药的吸收率（rate of absorption）或者生物利用度，因此仿制药就可以凭此与原创药进行比较。
The generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the innovator drug. 仿制药必须和原创药在同样的时间内将同样量的活性成分传输到患者的血流。
Using bioequivalence as the basis for approving generic copies of drug products was established by the "Drug Price Competition and Patent Term Restoration Act of 1984," also known as the Waxman-Hatch Act. 把生物等效性作为批准仿制药的基础是根据1984年的"药品价格竞争和专利恢复法案,"，来确立的，该法案也被称之为维克斯曼－哈奇法案。
This Act expedites the availability of less costly generic drugs by permitting FDA to approve applications to market generic versions of brand-name drugs without conducting costly and duplicative clinical trials. 本法令通过允许FDA批准品牌药的仿制版本的上市而无需进行昂贵和重复性的临床试验来加快较便宜的仿制药的获得。
At the same time, the brand-name companies can apply for up to five additional years longer patent protection for the new medicines they developed to make up for time lost while their products were going through FDA's approval process. 同时，品牌药厂家也可以为他们所开发的新药申请五年的专利保护延期以弥补他们产品在通过FDA批准过程所损失的时间。
Brand-name drugs are subject to the same bioequivalence tests as generics upon reformulation. 品牌药在改变配方时也要进行和仿制药一样的生物等效性实验。
For more information on generic drug bioequivalency requirements, please see the chapter entitled "FDA Ensures Equivalence of Generic Drugs" in "From Test Tube to Patient: Improving Health Through Human Drugs."关于仿制药生物等效性方面要求的更多信息，请参见"从试管到患者：通过药品提高健康."The Office of Generic Drugs home page provides additional information to generic drug developers, including an interactive flowchart presentation of the ANDA review process, focusing on how CDER determines the safety and bioequivalence of generic drug products prior to approval for marketing. 仿制药办公室的主页为仿制药开发者提供了更多的信息，包括一个互动性的ANDA评审过程流程图，重点在于CDER在批准仿制药上市前是如何确定其安全性和生物等效性的。
Generic drug application reviewers focus on bioequivalence data, chemistry and microbiology data, requests for plant inspection, and drug labeling information.仿制药申请的的评审官着重于生物等效性资料，化学和生物资料，工厂检查的要求和药品标签信息等。
This web site is designed for individuals from pharmaceutical companies, government agencies, academic institutions, private organizations, or other organizations interested in bringing a generic drug to market. 本网址是为来自制药企业，政府机关，学术单位，私营组织或其它组织中对将仿制药带入市场感兴趣的个人而设计的。
Each of the sections below contains information from CDER to assist you in the ANDA application process. 下面的每一个章节都包括了来自CDER的信息以为你在ANDA申请过程中提供帮助。
Click on a link to go directly to a section.点击链接直接进入相应的章节。
Resources for ANDA SubmissionsANDA递交方面的资源The following resources have been gathered to provide you with the legal requirements of an ANDA application, assistance from CDER to help you meet those requirements, and internal ANDA review principles, policies and procedures.如下资源集中在一起为你提供了ANDA申请的法律要求，来自于CDER的支持以帮助你满足他们的要求，ANDA的内部评审原则，政策和程序。