系列2：使用者费用User Fees
本部分收录了FDA关于使用者费用直接相关的指南：
美国仿制药使用者付费修正案（GDUFA）旨在加快安全有效仿制药的供应，并提高审评过程的可预测性。GDUFA基于FDA与仿制药行业代表协商的协议，应对越来越多的监管挑战。GDUFA要求制药企业向FDA支付仿制药申请的审评费用和检查设施成本费，以帮助FDA增加资源和人员，减少审评积压、缩短仿制药申请审评所需的平均时间，同时增加风险检查。
2.1_GDUFA II背景下，评估使用者费用
Assessing User Fees Under the Generic Drug User Fee Amendments of 2017
发布日期：11/01/2019
目前状态：草案
This guidance provides stakeholders information regarding FDA’s implementation of the Generic Drug User Fee Amendments of 2017 (GDUFA II) under Title III of the FDA Reauthorization Act of 2017. Because GDUFA II created changes to the user fee program, this guidance serves to provide an explanation about the new fee structure and types of fees for which entities are responsible.
针对利益相关者，该指南提供了有关FDA实施2017年仿制药使用者费用修正案(GDUFA II)的信息，GDUFA II 是在2017年FDA重新授权法案第3编下。
This guidance describes the types of user fees authorized by GDUFA II, the process for submitting payments to FDA, the consequences for failing to pay generic drug user fees, and the process for requesting a reconsideration of a user fee assessment.
本指南描述了由GDUFA II许可的使用者费用的类型，向FDA支付款项的流程，未支付仿制药使用者费用的后果，以及请求重新考虑使用者费用评估的流程。
This guidance also describes how FDA determines affiliation for purposes of assessing generic drug user fees.
本指南还描述了FDA如何确定从属关系，以评估仿制药使用者费用。
FDA will issue separate guidance documents regarding GDUFA II non-user fee requirements and processes. This guidance does not address how FDA determines and adjusts fees each fiscal year, nor does it address FDA’s implementation of other user fee programs (e.g., Prescription Drug User Fee Amendments, Biosimilar Biological User Fee Amendments).
FDA将发布有关GDUFA II非用户费用要求和程序的单独指南。本指南既未解决FDA在每个财政年度如何确定和调整费用的问题，也未解决FDA对其他用户费用计划(例如，处方药用户费用修正案，生物类似生物用户费用修正案)的实施。
Throughout this guidance, references to user fees or the user-fee program indicate generic drug user fees collected under section 744B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
在本指南中，对用户费用或用户费用计划的引用，是基于联邦FD＆C法案第744B条的仿制药用户费收取规定。
This guidance revises and replaces FDA’s draft guidance for industry Assessing User Fees Under the Generic Drug User Fee Amendments of 2017, published in October 2017.
本指南修正并取代了FDA 2017年仿制药使用者费用修正案下的使用者费用评估指南草案(于2017年10月发布)。
2.2_ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA
2.2_ANDA提交— GDUFA下的ANDA修正
发布日期：07/05/2018
目前状态：定稿
This guidance is intended to explain to applicants how the review goals established as part of the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II) apply to amendments to either abbreviated new drug applications (ANDAs) or prior approval supplements (PASs) submitted to the Food and Drug Administration under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)).
本指南旨在向申请人解释：作为GDUFA II的一部分而建立的审查目标，如何适用于提交给FDA的ANDA申请或PAS修正，这些申请是基于联邦FD＆C 法案第505(j)条的规定。
This guidance describes amendment classifications and categories and explains how amendment submissions may affect an application’s review goal dates. The guidance also describes how FDA should assess amendments submitted to ANDAs and PASs received prior to October 1, 2017, which is the GDUFA II review goals effective date.
本指南介绍了修正的分类和类别，并解释了修正提交如何影响申请的审查目标日期。
就FDA如何评估2017年10月1日(即GDUFA II审查目标生效日期)之前提交给ANDA和PAS的修正，该指南也进行了描述。
2.2_ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA
2.2_ANDA提交— GDUFA下的ANDA修正
发布日期：07/05/2018
目前状态：定稿
This guidance is intended to explain to applicants how the review goals established as part of the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II) apply to amendments to either abbreviated new drug applications (ANDAs) or prior approval supplements (PASs) submitted to the Food and Drug Administration under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)).
本指南旨在向申请人解释：作为GDUFA II的一部分而建立的审查目标，如何适用于提交给FDA的ANDA申请或PAS修正，这些申请是基于联邦FD＆C 法案第505(j)条的规定。
This guidance describes amendment classifications and categories and explains how amendment submissions may affect an application’s review goal dates. The guidance also describes how FDA should assess amendments submitted to ANDAs and PASs received prior to October 1, 2017, which is the GDUFA II review goals effective date.
本指南介绍了修正的分类和类别，并解释了修正提交如何影响申请的审查目标日期。
就FDA如何评估2017年10月1日(即GDUFA II审查目标生效日期)之前提交给ANDA和PAS的修正，该指南也进行了描述。
2.3_ ANDA Submissions – Prior Approval Supplements Under GDUFA
2.3_ ANDA提交— GDUFA下的批准前补充
发布日期：10/04/2017
目前状态：定稿
This guidance is intended to assist applicants preparing to submit to FDA prior approval supplements (PASs) and amendments to PASs for abbreviated new drug applications (ANDAs) under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)).
准备根据联邦FD＆C法案第505(j)条的规定，本指南旨在帮助申请人向FDA提交PAS和PAS修正，以用于ANDA申请。
The guidance explains how the Generic Drug User Fee Amendments of 2012 (GDUFA) relates to PAS submissions.
该指南说明了2012年仿制药使用者费用修正案(GDUFA)与PAS提交内容之间的关系。
该指南还描述了：
The guidance also describes the performance metric goals outlined in the GDUFA Program Performance Goals and Procedures for fiscal years 2015 through 2017 (GDUFA I) and the GDUFA Reauthorization Performance Goals and Program Enhancements fiscal years 2018-2022 (GDUFA II) Commitment Letters that FDA has agreed to meet, and clarifies how FDA will handle a PAS and amendments to a PAS for an ANDA subject to the GDUFA performance metric goals.
(1) 2015-2017财政年度(GDUFA I):GDUFA计划绩效目标和程序中概述的绩效指标目标；
(2) GDUFA 2018-2022财年(GDUFA II):再授权绩效目标和增强计划承诺书
(3)并阐明FDA将如何按照GDUFA绩效指标目标处理ANDA的PAS和PAS修正。
2.4_ Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments
2.4_ 2012年仿制药使用者费用修正案：与使用者费用评估有关的问答
发布日期：11/22/2016
目前状态：定稿
This guidance provides answers to anticipated user-fee questions from generic drug industry participants regarding the Generic Drug User Fee Amendments of 2012 (Public Law 112-144, Title III), commonly referred to as GDUFA.The questions and answers (Q&A) format is intended to promote transparency and facilitate compliance. The first version of this document was issued pursuant to 21 CFR 10.115 and was made available on FDA’s website on August 22, 2012. In response to comments received in the docket and to address additional questions that have arisen since the beginning of GDUFA, FDA issued Revision 1 of the draft guidance on September 10, 2013.
对仿制药行业参与者有关2012年仿制药使用者费用修正案(第112-144号公共法，第III条)(通常称为GDUFA)的预期使用者费用情况，本指南提供了问答。问答格式旨在提高透明度，并促进合规性。该文件的最初版是根据21 CFR 10.115发行的，已于2012年8月22日在FDA网站上发布。为响应文件摘要中收到的评论，并解决自GDUFA成立以来出现的其他问题，2013年9月10日。FDA发布了本文件的草案版本。
2.5_Self-Identification of Generic Drug Facilities, Sites, and Organizations
2.5_仿制药设施、场所和组织的自我识别：问答指南
发布日期：09/23/2016
目前状态：定稿
This guidance is intended to assist human generic drug facilities, sites, and organizations by describing how to comply with the self-identification requirement contained in the Generic Drug User Fee Amendments of 2012 (Public Law 112-144, Title III), commonly referred to as GDUFA.
本指南旨在通过描述如何遵守2012年仿制药使用者费用修正案(第112-144号公共法，第III条)，这通常称作为GDUFA。
