系列1：行政/程序性指南Administrative/Procedural
本部分收录了FDA关于特殊类型仿制药的行政程序性规定，包括竞争性仿制疗法和180天的市场独占期等：
1)FDA可以应申请人的要求，将“仿制竞争不足”的药品指定为竞争性仿制疗法(CGT)。根据申请人的要求，对于CGT的ANDA申请流程，FDA还可以加快开发和审查过程。
2)在“专利无效或者批准正在申请的药物不会侵犯专利”的情况下，第一个向FDA递交ANDA的申请者将拥有180天的市场独占期。在这180天内，仿制药企业可以快速收回投资，并在市场被其他仿制药充斥之前确立其地位。
1.1 Competitive Generic Therapies
1.1 竞争性仿制疗法
发布日期：03/16/2020
目前状态：定稿
The FDA Reauthorization Act of 2017, or FDARA, created a new pathway by which FDA may, at the request of the applicant, designate a drug with “inadequate generic competition” as a competitive generic therapy (CGT). At the request of the applicant, FDA may also expedite the development and review of an abbreviated new drug application (ANDA) for a drug designated as a CGT.
2017年的FDA重新授权法案(FDARA)开辟了一条新途径，FDA可以应申请人的要求，将“仿制竞争不足”的药品指定为竞争性仿制疗法(CGT)。根据申请人的要求，对于CGT的ANDA申请流程，FDA还可以加快开发和审查过程。
This guidance provides a description of the process that applicants should follow to request designation of a drug as a CGT and the criteria for designating a drug as a CGT.
本指南描述了申请人要求将药品指定为CGT所应遵循的流程，以及将药品指定为CGT的标准。
It also includes information on the actions FDA may take to expedite the development and review of ANDAs for drugs designated as CGTs.
它还包括有关FDA可能采取的措施，以加快开发和审查指定为CGT的药品的ANDA的信息。
Finally, it provides information on how FDA implements the statutory provision for a 180-day exclusivity period for certain first approved applicants that submit ANDAs for CGTs.
最后，针对某些首先批准的申请人(提交了CGT的ANDA)，就FDA如何执行180天独占期法定规定，本指南提供了相关信息。
1.2 Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data
1.2 制定并提交有关患者体验数据的拟议指南草案
发布日期：12/21/2018
目前状态：草案
This draft guidance is being developed under the 21st Century Cures Act (Cures Act), which directs FDA to issue guidance on how a person seeking to develop and submit a proposed draft guidance relating to patient experience data for consideration by FDA may submit such proposed draft guidance to the Agency.
该指南草案是根据 21世纪治愈法(Cures Act)制定的。对于寻求制定和提交与患者经验数据有关的拟议指南草案以供FDA考虑的人，可以向FDA提交这种拟议的指南草案。
1.3_ 180-Day Exclusivity: Questions and Answers
1.3_ 180天独占期问答指南
发布日期：01/12/2017
目前状态：草案
This guidance is intended to address questions that have been raised about the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that relate to generic drug exclusivity, which commonly is known as 180-day exclusivity for generic drug products. As a general matter, the Food and Drug Administration (FDA or the Agency) has implemented these statutory provisions within the context of application-specific decisions.
本指南旨在解决有关联邦FD＆C法案与仿制药独占期有关的问题，该规定通常称为仿制药产品180天独占期。通常，针对特定申请的决策中，FDA已在实施了这些法定规定。
1.4_180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day
1.4_同一天提交多个ANDA的180天独占期
发布时间：07/01/2003
目前状态：定稿
This guidance explains how FDA intends to determine eligibility for 180-day exclusivity when multiple substantially complete abbreviated new drug applications (ANDAs) that contain a paragraph IV certification to the same patent(s) are submitted on the same day or when paragraph IV certifications are submitted in an amendment or supplement on the same day.
本指南解释了FDA如何确定180天独占期的资格，针对两种情况下：
(1)当同一天提交多个基本完整的简略新药申请(ANDA)，包含同一专利的第IV段认证时；
(2)在同一天以修正或补充形式，提交第IV段认证时。
1.5_Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act.
1.5_基于联邦FD＆C法案的Hatch-Waxman修正案下的法院判决、ANDA批准和180天独占期
发布日期：03/30/2000
目前状态：定稿
This guidance is being issued in response to recent litigation and is intended to provide guidance to the pharmaceutical industry regarding
本指南是针对最近的诉讼发布的，旨在为制药行业提供以下方面的指南：
(1) the timing of approval of abbreviated new drug applications (ANDAs) following an unsuccessful patent infringement action by the patent owner or new drug application (NDA) holder and
(1)专利所有人或NDA持有人未成功进行专利侵权诉讼后，批准ANDA的时间，
(2) the start of 180 days of generic drug exclusivity.
(2)仿制药180天独占期的开始。
1.6_180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act
1.6_基于联邦FD＆C法案的Hatch-Waxman修正案下的180天仿制药独占期
发布日期：06/01/1998
目前状态：定稿
This guidance is intended to provide industry with information on how the Food and Drug Administration (FDA) is applying the 180-day generic drug exclusivity provisions of the Federal Food, Drug, and Cosmetic Act (the Act) in light of recent court decisions. The guidance addresses the issue of the elimination of the "successful defense" requirement, which required an abbreviated new application (ANDA) applicant to be sued for patent infringement and to prevail in the litigation to receive the 180-day period of marketing exclusivity. This guidance will remain in effect until superseded by new regulations or new guidance.
就FDA如何根据最近法院判决应用联邦FD＆C法案中180天仿制药独占期规定，本指南旨在为行业提供了信息。该指南解决了取消“成功辩护”要求的问题，这是要求ANDA申请人提出专利侵权诉讼，并在诉讼中胜诉，以享有180天的市场独占期。该指南将一直有效，直到被新法规或新指南取代。
