(3)(A) The Secretary shall issue guidance for the individuals who review applications submitted under paragraph (1), which shall relate to promptness in conducting the review, technical excellence, lack of bias and conflict of interest, and knowledge of regulatory and scientific standards, and which shall apply equally to all individuals who review such applications.
(3)(A)卫生部应将指南发布给审核按（1）部分递交的申请的人员。指南应关乎审核的及时性，技术性，不带偏见和利益冲突，以及关乎法规知识和科学的标准，并且应当适用于所有审核人员。
(B) The Secretary shall meet with a sponsor of an investigation or an applicant for approval for a drug under this subsection if the sponsor or applicant makes a reasonable written request for a meeting for the purpose of reaching agreement on the design and size of bioavailability and bioequivalence studies needed for approval of such application. The sponsor or applicant shall provide information necessary for discussion and agreement on the design and size of such studies. Minutes of any such meeting shall be prepared by the Secretary and made available to the sponsor or applicant.
(B) 如果发起人或者药品批准的申请人提出合理的书面申请要求与卫生部召开会议，就生物等效性或者生物利用度研究的设计和规模商量达成一致，卫生部应与之会面。发起人或者申请人应提供必要的信息用于上述研究的设计和规模的讨论和意见的达成。会议记录由卫生部准备并提供给发起人或者申请者。
(C) Any agreement regarding the parameters of design and size of bioavailability and bioequivalence studies of a drug under this paragraph that is reached between the Secretary and a sponsor or applicant shall be reduced to writing and made part of the administrative record by the Secretary. Such agreement shall not be changed after the testing begins, except—
(C) 任何卫生部和发起人或者申请者达成一致的，有关药品生物利用度或者生物等效性研究的设计和规模参数相关的协议，都应由卫生部书面记录并成为行政记录的一部分。实验开始后，协议不可再更改，除非：
(i) with the written agreement of the sponsor or applicant; or
(i) 发起人或者申请者书面同意变更；或者
(ii) pursuant to a decision, made in accordance with subparagraph (D) by the director of the reviewing division, that a substantial scientific issue essential to determining the safety or effectiveness of the drug has been identified after the testing has begun.
(ii)审评主管发现该药品有跟安全性有效性有关的重大科学问题，根据段落D的要求作出决定。
(D) A decision under subparagraph (C)(ii) by the director shall be in writing and the Secretary shall provide to the sponsor or applicant an opportunity for a meeting at which the director and the sponsor or applicant will be present and at which the director will document the scientific issue involved.
(D) C部分(ii)的决定应以书面的形式，并且卫生部应当给发起人或申请者提供机会与审评主管开会，会上审评主管和发起人或申请者将全部出席并且审评主管将用文件证明所涉及的科学问题。
(E) The written decisions of the reviewing division shall be binding upon, and may not directly or indirectly be changed by, the field or compliance office personnel unless such field or compliance office personnel demonstrate to the reviewing division why such decision should be modified.
(E) 审核部门的书面决定应当具有约束力，不能直接或者间接被GMP现场审计人员变更，除非该审计人员能向审核部门证明该决定为什么应当修订。
(F) No action by the reviewing division may be delayed because of the unavailability of information from or action by field personnel unless the reviewing division determines that a delay is necessary to assure the marketing of a safe and effective drug.
(F) 审评部门不能因为现场审计人员不可行的信息或者采取了不可行的措施而推迟做决定，除非审评部门判断延迟是必要的，以确保安全有效的药品上市。
(G) For purposes of this paragraph, the reviewing division is the division responsible for the review of an application for approval of a drug under this subsection (including scientific matters, chemistry, manufacturing, and controls).
(G) 就本章节而言，审评部门指的是负责审核批准药品申请的部门（包括审核科学事务，化学，生产和控制）
(4) Subject to paragraph (5), the Secretary shall approve an application for a drug unless the Secretary finds—
(4) 根据（5）的要求，卫生部应当批准药品的申请，除非发现以下问题：
(A) the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of the drug are inadequate to assure and preserve its identity, strength, quality, and purity;
(A) 药品生产，加工和包装过程中用到的方法，设施和控制不足以保证和维持药品的特性，规格，质量和纯度；
(B) information submitted with the application is insufficient to show that each of the proposed conditions of use have been previously approved for the listed drug referred to in the application;
(B) 申请中提供的信息不足以证明申请中的每个药品的使用条件，该药品申请中参考的对照药都已经被批准。
(C)(i) if the listed drug has only one active ingredient, information submitted with the application is insufficient to show that the active ingredient is the same as that of the listed drug;
(C)(i) 如果对照药只有一个活性成分，申请提供的信息不足以证明其活性成分与对照药的一致
(ii) if the listed drug has more than one active ingredient, information submitted with the application is insufficient to show that the active ingredients are the same as the active ingredients of the listed drug, or
(ii) 如果对照药有多于一个的活性成分，申请提供的信息不足以证明其活性成分与对照药的一致，或者
(iii) if the listed drug has more than one active ingredient and if the application is for a drug which has an active ingredient different from the listed drug, information submitted with the application is insufficient to show—
(iii) 如果对照药有多于一个的活性成分，申请的药品其中一个活性成分与对照药不同，申请提供的信息不足以证明
(I) that the other active ingredients are the same as the active ingredients of the listed drug, or
(I) 其他的活性成分与对照药的一致，或者
(II) that the different active ingredient is an active ingredient of a listed drug or a drug which does not meet the requirements of section 321(p) of this title, or no petition to file an application for the drug with the different ingredient was approved under paragraph (2)(C);
(II)不同的活性成分是其他上市药品使用过，不是新的活性成分，该不同活性成分没有通过请愿途径得到批准
(D)(i) if the application is for a drug whose route of administration, dosage form, or strength of the drug is the same as the route of administration, dosage form, or strength of the listed drug referred to in the application, information submitted in the application is insufficient to show that the route of administration, dosage form, or strength is the same as that of the listed drug, or
(D)(i) 如果申请的药品给药途径，剂型和规格与申请中参照的对照药一致，提供的信息不足以证明与对照药的给药途径，剂型和规格一致，或者
(ii) if the application is for a drug whose route of administration, dosage form, or
strength of the drug is different from that of the listed drug referred to in the application, no petition to file an application for the drug with the different route of administration, dosage form, or strength was approved under paragraph (2)(C);
(ii) 如果申请的药品的给药途径，剂型或规格与申请中参照的对照药不一致，没有通过请愿途径得到批准
(E) if the application was filed pursuant to the approval of a petition under paragraph (2)(C), the application did not contain the information required by the Secretary respecting the active ingredient, route of administration, dosage form, or strength which is not the same;
(E) 如果申请中不同活性成分，给药途径，剂型或者规格的信息已通过备案途径得到批准，但是备案的信息没有按照卫生部的要求在申请中体现。
(F) information submitted in the application is insufficient to show that the drug is bioequivalent to the listed drug referred to in the application or, if the application was filed pursuant to a petition approved under paragraph (2)(C), information submitted in the application is insufficient to show that the active ingredients of the new drug are of the same pharmacological or therapeutic class as those of the listed drug referred to in paragraph (2)(A)(i) and that the new drug can be expected to have the same therapeutic effect as the listed drug when administered to patients for a condition of use referred to in such paragraph;
(F) 申请递交的信息不足以证明与对照药生物等效，或者仿制药与对照药不具有生物等效性已经通过请愿的方式得到批准，但是申请递交的信息不足以证明仿制药中的活性成分与对照药中的活性成分是相同的药理或者治疗领域，并且不能证明当仿制药按照对照药的使用条件被患者服用后能产生与对照药相同的治疗效果。
(G) information submitted in the application is insufficient to show that the labeling proposed for the drug is the same as the labeling approved for the listed drug referred to in the application except for changes required because of differences approved under a petition filed under paragraph (2)(C) or because the drug and the listed drug are produced or distributed by different manufacturers;
(G) 申请递交的信息不足以证明仿制药的标签与对照药的标签一致，已通过请愿方式得到批准或者因为不同生产和销售商变更的信息除外。
(H) information submitted in the application or any other information available to the Secretary shows that (i) the inactive ingredients of the drug are unsafe for use under the conditions prescribed, recommended, or suggested in the labeling proposed for the drug, or (ii) the composition of the drug is unsafe under such conditions because of the type or quantity of inactive ingredients included or the manner in which the inactive ingredients are included;
(H) 申请中递交的信息或者其他任何卫生部可利用的信息显示（i）根据药品标签上规定，要求或者建议的条件下服用药品，药品的非活性成分是不安全的；或者（ii）上述情况下药品的组成因为包含的辅料类型或者量，或者辅料被包括的形式而不安全
(I) the approval under subsection (c) of this section of the listed drug referred to in the application under this subsection has been withdrawn or suspended for grounds described in the first sentence of subsection (e) of this section, the Secretary has published a notice of opportunity for hearing to withdraw approval of the listed drug under subsection (c) of this section for grounds described in the first sentence of subsection (e) of this section, the approval under this subsection of the listed drug referred to in the application under this subsection has been withdrawn or suspended under paragraph (6), or the Secretary has determined that the listed drug has been withdrawn from sale for safety or effectiveness reasons;
(I) 本部分(c)中申请涉及的对照药因安全性有效性的原因被撤销或者废除，卫生部已经公布了听证会的通知，通知申请者本部分(c)中申请涉及的对照药因安全性有效性的原因被撤销或者废除，或者卫生部因为药品安全性或者有效性的问题决定将对照药撤市。
(J) the application does not meet any other requirement of paragraph (2)(A); or
(J) 申请不满足（2）（A）的要求或者
(K) the application contains an untrue statement of material fact.
(K) 申请包含针对重要信息不真实的声明
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