(j) Abbreviated new drug applications仿制药申请
(1) Any person may file with the Secretary an abbreviated application for the approval of a new drug.
（1）任何人都可以在卫生部备案仿制药的申请
Secretary指的是美国卫生及公共服务部部长，the Secretary of Health and Human（以下简称“卫生部”）
(2)(A) An abbreviated application for a new drug shall contain—
（2）（A）仿制药的申请应当包括以下内容：
(i) information to show that the conditions of use prescribed, recommended, or suggested in the labeling proposed for the new drug have been previously approved for a drug listed under paragraph (7) (hereinafter in this subsection referred to as a ‘‘listed drug’’);
（i）提供信息证明仿制药标签中规定，要求或建议的使用条件，在章节7列出的药品（下文简称“对照药”）中已经被批准;
(ii)(I) if the listed drug referred to in clause (i) has only one active ingredient, information to show that the active ingredient of the new drug is the same as that of the listed drug;
（ii）（I）如果对照药只有一个活性成分，需提供信息证明仿制药的活性成分与对照药的活性成分一致；
(II) if the listed drug referred to in clause (i) has more than one active ingredient, information to show that the active ingredients of the new drug are the same as those of the listed drug, or
（II）如果对照药有多个活性成分，需要提供信息证明仿制药的活性成分与对照药的多个活性成分一致，或者
(III) if the listed drug referred to in clause (i) has more than one active ingredient and if one of the active ingredients of the new drug is different and the application is filed pursuant to the approval of a petition filed under subparagraph (C), information to show that the other active ingredients of the new drug are the same as the active ingredients of the listed drug, information to show that the different active ingredient is an active ingredient of a listed drug or of a drug which does not meet the requirements of section 321(p) of this title, and such other information respecting the different active ingredient with respect to which the petition was filed as the Secretary may require;
（III）如果对照药有多个活性成分，仿制药的其中一个活性成分与对照药不同，该不同活性成分已经按照章节C请愿的方式得到批准，需要提供信息证明仿制药的其他活性成分与对照药一致，唯一不同的活性成分是其他上市药品用过的，不是新的活性成分，还有其他卫生部要求的与该不同活性成分有关的，请愿书中备案的信息。
(iii) information to show that the route of administration, the dosage form, and the strength of the new drug are the same as those of the listed drug referred to in clause (i) or, if the route of administration, the dosage form, or the strength of the new drug is different and the application is filed pursuant to the approval of a petition filed under subparagraph (C), such information respecting the route of administration, dosage form, or strength with respect to which the petition was filed as the Secretary may require;
（iii）提供信息证明仿制药的给药途径，剂型和规格与对照药相同，如果仿制药的给药途径，剂型和规格与对照药不同，并且已经通过请愿的方式得到批准，需要按照卫生部的要求提供与给药途径，剂型和规格有关的，请愿书中备案的信息。
(iv) information to show that the new drug is bioequivalent to the listed drug referred to in clause (i), except that if the application is filed pursuant to the approval of a petition filed under subparagraph (C), information 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 clause (i) and 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 clause (i);
（iv）提供信息证明仿制药与对照药具有生物等效性，如果不具有生物等效性，需要通过请愿的方式得到批准，同时还需要提供信息证明仿制药的活性成分与对照药是相同的药理学或者治疗类别，并且病人按照对照药的给药条件服用该仿制药，与对照药有相同的治疗效果。
(v) information to show that the labeling proposed for the new drug is the same as the labeling approved for the listed drug referred to in clause (i) except for changes required because of differences approved under a petition filed under subparagraph (C) or because the new drug and the listed drug are produced or distributed by different manufacturers;
（v）提供信息证明仿制药的标签与对照药已批准的标签一致，通过请愿方式得到批准，或者因为仿制药和对照药由不同厂家生产或销售，所做的变更除外。
(vi) the items specified in clauses (B) through (F) of subsection (b)(1) of this section;
（vi）本章节（b）（1）B至F条款中具体阐述的项目
即
B.反应成品组成的物料清单；
C.处方详细的描述；
D.生产，加工或者包装过程中使用的方法，设施以及控制的描述；
E.卫生部可能要求的药品或其他辅料的样品；
F.标签样本
(vii) a certification, in the opinion of the applicant and to the best of his knowledge, with respect to each patent which claims the listed drug referred to in clause (i) or which claims a use for such listed drug for which the applicant is seeking approval under this subsection and for which information is required to be filed under subsection (b) or (c) of this section—
(I) that such patent information has not been filed,
(II) that such patent has expired,
(III) of the date on which such patent will expire, or
(IV) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted; and
(vii)提供对照药或者该对照药的适应症的专利声明，仿制药申请寻求该适应症的批准，专利声明包括以下四种类型：
(I)专利信息未备案，
(II)专利已过期，
(III)专利即将失效的日期，或
(IV)专利无效，或者递交申请的药品的生产，使用或者销售不会对专利造成侵权，并且
(viii) if with respect to the listed drug referred to in clause (i) information was filed under subsection (b) or (c) of this section for a method of use patent which does not claim a use for which the applicant is seeking approval under this subsection, a statement that the method of use patent does not claim such a use.
(viii) 如果对照药，按照(b)和(c)的要求对适应症专利进行了备案，申请人寻求批准的使用不涉及该适应症专利，需要提供声明，适应症专利并未包含申报的药品使用。
The Secretary may not require that an abbreviated application contain information in addition to that required by clauses (i) through (viii).
除了第(i)到第(viii)条的信息，卫生部应该不会要求仿制药申请提供其他额外的信息。
(B) NOTICE OF OPINION THAT PATENT IS INVALID OR WILL NOT BE INFRINGED.—专利无效或者不会被侵权的意见通知
(i) AGREEMENT TO GIVE NOTICE.—An applicant that makes a certification described in subparagraph (A)(vii)(IV) shall include in the application a statement that the applicant will give notice as required by this subparagraph.
（i）同意提供通知—提供P（IV）专利声明（挑战专利）的申请人，应当在申请中包含一份声明，表明申请人将按照本部分要求提供通知：
(ii) TIMING OF NOTICE.—An applicant that makes a certification described in subparagraph (A)(vii)(IV) shall give notice as required under this subparagraph—
（ii）通知的时间--提供P（IV）专利声明的申请人应该按照以下要求提供通知：
(I) if the certification is in the application, not later than 20 days after the date of the postmark on the notice with which the Secretary informs the applicant that the application has been filed; or
（I）如果专利声明包含在申请中，自卫生部通知申请人申请已被备案的邮戳日期起20天内，（即申请人拿到ANDA接收函之日起）或者
(II) if the certification is in an amendment or supplement to the application, at the time at which the applicant submits the amendment or supplement, regardless of whether the applicant has already given notice with respect to another such certification contained in the application or in an amendment or supplement to the application.
（II）如果声明包含在修订或者补充中，申请人需在递交修订或者补充之日通知，不论申请人是否先前已经在申请，修订或者补充中提供了另一份这样的声明并且进行了通知。
(iii) RECIPIENTS OF NOTICE.—An applicant required under this subparagraph to give notice shall give notice to—通知的接收人--申请人应当通知
(I) each owner of the patent that is the subject of the certification (or a representative of the owner designated to receive such a notice); and
（I）声明中专利的每个拥有人（或者拥有人指定接收通知的代表）；以及
(II) the holder of the approved application under subsection (b) of this section for the drug that is claimed by the patent or a use of which is claimed by the patent (or a representative of the holder designated to receive such a notice).
(II) (b)项下已批准的，有药品专利主张或者适应症专利主张的NDA持有人（或者持有人指定接收通知的代表）
(iv) CONTENTS OF NOTICE.—A notice required under this subparagraph shall—通知的内容--通知应该包括：
(I) state that an application that contains data from bioavailability or bioequivalence studies has been submitted under this subsection for the drug with respect to which the certification is made to obtain approval to engage in the commercial manufacture, use, or sale of the drug before the expiration of the patent referred to in the certification; and
（I）声明药品包含BA或者BE研究数据的申请已经按照本部分要求递交，并且寻求批准在专利声明中所涉及的专利过期前进行此药品的商业化生产，使用或销售；并且
(II) include a detailed statement of the factual and legal basis of the opinion of the applicant that the patent is invalid or will not be infringed.
(II) 包含一份详细的声明，证明专利无效或者不侵权的事实和法律依据
(C) If a person wants to submit an abbreviated application for a new drug which has a different active ingredient or whose route of administration, dosage form, or strength differ from that of a listed drug, such person shall submit a petition to the Secretary seeking permission to file such an application. The Secretary shall approve or disapprove a petition submitted under this subparagraph within ninety days of the date the petition is submitted. The Secretary shall approve such a petition unless the Secretary finds—
（C）如果申请人递交的仿制药申请与对照药相比，有一个活性成分不同，或者给药途径，剂型或规格不同，申请者应当向卫生部提供一份请愿书，请求该申请的备案。自接收请愿书之日起，卫生部应当在90日天内做出批准或者不批准的决定。卫生部应该批准请愿书，除非发现以下问题：
(i) that investigations must be conducted to show the safety and effectiveness of the drug or of any of its active ingredients, the route of administration, the dosage form, or strength which differ from the listed drug; or
（i）对于活性成分，给药途径，剂型或者规格与对照药不同的仿制药，必须要实施临床研究才能证明药品的安全性和有效性；
(ii) that any drug with a different active ingredient may not be adequately evaluated for approval as safe and effective on the basis of the information required to be submitted in an abbreviated application.
（ii）仿制药申请中提供的信息不足以充分评估或者批准该不同活性成分药品的安全性和有效性
(D)(i) An applicant may not amend or supplement an application to seek approval of a drug referring to a different listed drug from the listed drug identified in the application as submitted to the Secretary.
（D）（i）申请人不能对申请进行修订或者补充，更换对照药，以寻求药品的批准。
(ii) With respect to the drug for which an application is submitted, nothing in this subsection prohibits an applicant from amending or supplementing the application to seek approval of a different strength.
（ii）已递交申请的药品，可以在修订或者补充中增加新的规格
(iii) Within 60 days after December 8, 2003, the Secretary shall issue guidance defining the term ‘‘listed drug’’ for purposes of this subparagraph.
7 Z H+ J4 h( \+ ^1 p9 m, L- A
（iii）为了实施本条款，自2003年12月8日起60天内，卫生部应发布指南定义“对照药”
|手机版|药群论坛
( 蜀ICP备15007902号 )
收藏
支持
反对