【转载】505(b)

【转载】505(b)  

2014-10-16 22:58:30|  分类： FDA|举报|字号 [url=]订阅[/url]

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本文转载自aimerjiaer《505(b)》http://zhuyujiao1972.blog.163.com/blog/static/986947272014916105830887/
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(b) Filing application; contents申请备案；内容

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(1) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a) of this section. Such person shall submit to the Secretary as a part of the application (A) full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use; (B) a full list of the articles used as components of such drug; (C) a full statement of the composition of such drug; (D) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (E) such samples of such drug and of the articles used as components thereof as the Secretary may require; (F) specimens of the labeling proposed to be used for such drug, and (G) any assessments required under section 355c of this title. The applicant shall file with the application the patent number and the expiration date of any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug. If an application is filed under this subsection for a drug and a patent which claims such drug or a method of using such drug is issued after the filing date but before approval of the application, the applicant shall amend the application to include the information required by the preceding sentence. Upon approval of the application, the Secretary shall publish information submitted under the two preceding sentences. The Secretary shall, in consultation with the Director of the National Institutes of Health and with representatives of the drug manufacturing industry, review and develop guidance, as appropriate, on the inclusion of women and minorities in clinical trials required by clause (A).

（1）任何人都可以按照本部分（a）的条款向当局递交任何药品的申请。申请人应当向当局递交以下内容（A）有关药品安全性有效性调查的完整报告（B）组成药品物质的完整清单（C）药品组方的完整声明（D）药品生产，加工以及包装过程中所使用的方法，设施和控制的描述（E）如果当局要求，需提供药品以及药品组成成分的样品（F）递交用于该药品的说明书的样本以及（G）本标题355c部分要求的任何评估。申请人应当在申请中登记备案任何与申请人所递交的产品或者产品的使用相关的专利的专利号和有效期，以便当任何人在未得到专利拥有者授权的情况下参与药品的生产，使用或者销售时，专利的侵权行为的索赔可以得到合理的宣判。申请按照本部分的要求对药品，药品以及药品使用的专利进行备案，如果专利在申请备案之后，被批准之前被公布的，申请人应当对申请进行补充，将上一句话中的专利信息包含在补充中。申请一旦得到批准，当局应当公布按照前两句话递交的信息。当局应当与美国国立卫生研究所的负责人，以及药品生产行业的代表进行磋商，视情况而定，审核和修订包含妇女以及少数族裔的，条款(A)所需求的临床实验指南。

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(2) An application submitted under paragraph (1) for a drug for which the investigations described in clause (A) of such paragraph and relied upon by the applicant for approval of the application were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted shall also include—

（2）按照（1）递交的药品的申请，与药品安全性有效性相关的条款(A)中所描述的，同时是申请人寻求批准所依赖的调查，并未由该药品的申请人实施，或者已有的调查并不是为了该申请人而实施，并且申请人并未从已做调查的人员那里获得引用或者使用的权限，这类的申请还应当包括-

(A) a certification, in the opinion of the applicant and to the best of his knowledge, with respect to each patent which claims the drug for which such investigations were conducted or which claims a use for such drug for which the applicant is seeking approval under this subsection and for which information is required to be filed under paragraph (1) or subsection (c) of this section—

（A）按照申请人的观念以及知识，出具一份每一个专利相关的声明，这些专利包括已做调查的药品的专利，按照本部分要求申请人寻求批准并且需要按照本部分（1）或者（c）要求备案信息的，药品使用的专利，声明分为四类--

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(i) that such patent information has not been filed,

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（i）声明该专利信息未备案

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(ii) that such patent has expired,

（ii）声明专利已过期

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(iii) of the date on which such patent will expire, or

（iii）声明专利将失效的日期，或者

(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

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（iv）声明该专利无效或者所递交申请的新药的生产，使用或者销售不会侵权；并且

(B) if with respect to the drug for which investigations described in paragraph (1)(A) were conducted information was filed under paragraph (1) or subsection (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.

（B）如果药品已经实施（1）（A）所描述的调查，与药品使用专利相关的信息按照（1）或者（c）的要求进行了备案，使用专利声明中不包括申请人寻求批准的使用方法，申请人需要出具声明，表明药品使用专利中不包括该申请的使用方法。

(3) NOTICE OF OPINION THAT PATENT IS INVALID OR WILL NOT BE INFRINGED.—

（3）专利无效或者不会被侵权的通知-

(A) AGREEMENT TO GIVE NOTICE.—An applicant that makes a certification described in paragraph (2)(A)(iv) shall include in the application a statement that the applicant will give notice as required by this paragraph.

（A）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

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(B) TIMING OF NOTICE.—An applicant that makes a certification described in paragraph (2)(A)(iv) shall give notice as required under this paragraph—

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（B）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：

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(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

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（i）（I）如果专利声明包含在申请中，自当局通知申请人申请已被备案的邮戳日期起20天内，或者

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(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。

(C) RECIPIENTS OF NOTICE.—An applicant required under this paragraph to give notice shall give notice to—

（C）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

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（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 this subsection 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）已批准的，专利所声明的药品或者药品使用的申请的持有人（或者持有人指定接收通知的代表）

(D) CONTENTS OF NOTICE.—A notice required under this paragraph 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）声明药品包含生物利用度或者生物等效性研究数据的申请已经按照本部分要求递交，该药品的申请提供声明寻求批准，以便在声明的专利到期之前商业化生产，使用和销售该药品；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.

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（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

(4)(A) An applicant may not amend or supplement an application referred to in paragraph (2) to seek approval of a drug that is a different drug than the drug identified in the application as submitted to the Secretary.

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（4）（A）参照条款（2）递交的申请，申请人不得对其进行修订或者补充以寻求另一药品的批准，该药品与先前递交给当局的申请中指定的药品不同。

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(B) With respect to the drug for which such an application is submitted, nothing in this subsection or subsection (c)(3) of this section prohibits an applicant from amending or supplementing the application to seek approval of a different strength.

（B）已递交申请的药品，本部分或者（c）（3）没有要求规定不可以在修订或者补充中增加新的规格

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(5)(A) The Secretary shall issue guidance for the individuals who review applications submitted under paragraph (1) or under section 262 of title 42, 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.

(5)(A)当局应将指南发布给审核按（1）部分或者标题42 262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。

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(B) The Secretary shall meet with a sponsor of an investigation or an applicant for approval for a drug under this subsection or section 262 of title 42 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 clinical trials intended to form the primary basis of an effectiveness claim or, with respect to an applicant for approval of a biological product under section 262(k) of title 42, any necessary clinical study or studies. The sponsor or applicant shall provide information necessary for discussion and agreement on the design and size of the clinical trials. Minutes of any such meeting shall be prepared by the Secretary and made available to the sponsor or applicant upon request.

(B)按照本部分或者标题42 262部分的要求，如果发起人或者药品申请人提出合理的书面申请要求与当局召开会议，就初步形成药品有效性依据的临床试验的设计和规模达成一致的意见，或者对于按照标题42 262（k）部分寻求生物药批准的申请人，就任何生物药需要实施的临床研究达成一致意见，当局应当就调查问题与发起人会面，或者为了药品的批准问题与申请人会面。发起人或者申请人应提供必要的信息用于临床研究的设计和规模的讨论以及意见的达成。会议记录由当局准备，发起人或者申请者要求的话，当局应当能提供会议记录。

(C) Any agreement regarding the parameters of the design and size of clinical trials of a new 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) 任何当局和发起人或者申请者达成一致的，有关新药临床研究的设计和规模参数相关的协议，都应由当局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：

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(i) with the written agreement of the sponsor or applicant; or

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(i) 发起人或者申请者书面同意变更；或者

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(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)审核部门的负责人按照（D）的要求做出判定，一个实质性的判断药品安全性和有效性必不可少的科学问题在实验开始之后已经被解决。

(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.

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(D) C部分(ii)的决定应以书面的形式，并且当局应当给发起人或申请者提供机会与负责人开会，会上负责人和发起人或申请者将全部出席并且负责人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 division personnel unless such field or compliance division personnel demonstrate to the reviewing division why such decision should be modified.

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(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该领域或者法规办公室员工变更，除非该员工能向审核部门证明该决定为什么应当修订。

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(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.

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(F) 领域人员的信息或者行动无效不能延迟审核部门的行动，除非审核部门判断延迟是必要的，以确保安全有效的药品上市。

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(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 or section 262 of title 42 (including all scientific and medical matters, chemistry, manufacturing, and controls).

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(G) 就本章节而言，审核部门指的是按照本部分或者标题42 262部分的要求，负责审核寻求药品批准的申请的部门（包括审核所有科学的和医学的问题，化学，生产和控制）

(6) An application submitted under this subsection shall be accompanied by the certification required under section 282(j)(5)(B) of title 42. Such certification shall not be considered an element of such application.

（6）按照本部分要求递交的申请，同时应递交一份按照标题42 282（j）（5）（B）要求的声明。该声明应当单独提供，而不是作为申请的一部分提供。

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