【转载】505(j)(6)-(10)

【转载】505(j)(6)-(10)  

2014-10-16 23:00:44|  分类： FDA|举报|字号 [url=]订阅[/url]

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本文转载自aimerjiaer《505(j)(6)-(10)》http://zhuyujiao1972.blog.163.com/blog/static/98694727201491611044337/
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(6) If a drug approved under this subsection refers in its approved application to a drug the approval of which was withdrawn or suspended for grounds described in the first sentence of subsection (e) of this section or was withdrawn or suspended under this paragraph or which, as determined by the Secretary, has been withdrawn from sale for safety or effectiveness reasons, the approval of the drug under this subsection shall be withdrawn or suspended—

（6）如果已批准仿制药申请所参照的对照药因为安全性有效性问题被撤销，废除或者撤市，仿制药的申请也将在以下期限内被撤销或者废除-

(A) for the same period as the withdrawal or suspension under subsection (e) of this section or this paragraph, or

（A）对照药因为安全性有效性原因被撤销或者废除的的同一时间，或者

(B) if the listed drug has been withdrawn from sale, for the period of withdrawal from sale or, if earlier, the period ending on the date the Secretary determines that the withdrawal from sale is not for safety or effectiveness reasons.

（B）如果对照药已经撤市，在对照药撤市的日期或者更早的时间撤销或废除，仿制药的撤销或废除截止到卫生部判定对照药的撤市不是由于对照药安全性有效性的问题的当日。

(7)(A)(i) Within sixty days of September 24, 1984, the Secretary shall publish and make available to the public—

（7）（A）（i）1984年9月24日起六十天内，卫生部应当向公众发布并提供-

(I) a list in alphabetical order of the official and proprietary name of each drug which has been approved for safety and effectiveness under subsection (c) of this section before September 24, 1984;

(I) 一份1984年9月24日之前安全性和有效性已经得到NDA批准的药品清单，按照每个药品的官方和专利名的字母顺序排列；

(II) the date of approval if the drug is approved after 1981 and the number of the application which was approved; and

（II）如果是1981年之后批准的，要提供药品的批准日期以及批准的申请号；并且

(III) whether in vitro or in vivo bioequivalence studies, or both such studies, are required for applications filed under this subsection which will refer to the drug published.

（III）体内或者体外的生物等效性研究，或者两者兼有，需要归档在申请中，BE研究将参照已公布的对照药。

(ii) Every thirty days after the publication of the first list under clause (i) the Secretary shall revise the list to include each drug which has been approved for safety and effectiveness under subsection (c) of this section or approved under this subsection during the thirty-day period.

（ii）按照（i）的要求公布清单之后，每三十日卫生部需要升级清单，以包括这三十天内安全性和有效性已经按照（c）或者本部分要求得到批准的药品。

(iii) When patent information submitted under subsection (b) or (c) of this section respecting a drug included on the list is to be published by the Secretary, the Secretary shall, in revisions made under clause (ii), include such information for such drug.

（iii）如果卫生部即将收载到清单中的药品按照（b）和（c）的要求递交了专利信息，卫生部在按照（ii）的要求升级清单时，需要将药品的专利信息包括进去。

(B) A drug approved for safety and effectiveness under subsection (c) of this section or approved under this subsection shall, for purposes of this subsection, be considered to have been published under subparagraph (A) on the date of its approval or September 24, 1984, whichever is later.

（B）安全性和有效性已经按照（c）或者本部分要求得到批准的药品，为了实施本章节的条款，应当被认为已经按照（A）的要求在药品批准当日或者1984年9月24日，两者较晚的日期被公布。

(C) If the approval of a drug was withdrawn or suspended for grounds described in the first sentence of subsection (e) of this section or was withdrawn or suspended under paragraph (6) or if the Secretary determines that a drug has been withdrawn from sale for safety or effectiveness reasons, it may not be published in the list under subparagraph (A) or, if the withdrawal or suspension occurred after its publication in such list, it shall be immediately removed from such list—

（C）如果已批准药物因为安全性有效性原因被撤销，废除或撤市，卫生部，该药品可能不会按照（A）的要求被公布出版，如果该药品是在清单发布之后发生撤销或者废除的，应当立即在以下期限从清单中删除-

(i) for the same period as the withdrawal or suspension under subsection (e) of this section or paragraph (6), or

（i）药品因为安全性有效性原因被撤销或者废除的同一时间，或者

(ii) if the listed drug has been withdrawn from sale, for the period of withdrawal from sale or, if earlier, the period ending on the date the Secretary determines that the withdrawal from sale is not for safety or effectiveness reasons. A notice of the removal shall be published in the Federal Register.

（ii）如果对照药已经被撤市，在对照药撤市的日期或者更早的日期从清单上删除，删除截止到卫生部判定对照药的撤市不是由于对照药安全性有效性的问题的当日。清单上删除药品应当在联邦公报上进行通告。

(8) For purposes of this subsection:就本章节而言

(A)(i) The term ‘‘bioavailability’’ means the rate and extent to which the active ingredient or therapeutic ingredient is absorbed from a drug and becomes available at the site of drug action.

（A）（i）“生物利用度”指的是药品中有效成分或者治疗成分被机体吸收利用的速率和相对量。

(ii) For a drug that is not intended to be absorbed into the bloodstream, the Secretary may assess bioavailability by scientifically valid measurements intended to reflect the rate and extent to which the active ingredient or therapeutic ingredient becomes available at the site of drug action.

（ii）对于不进入血液循环的药物，卫生部可能通过科学有效的测量评估其生物利用度，测量的目的在于反映药物的活性成分或者有效成分在作用部位被利用的速率和相对量。

(B) A drug shall be considered to be bioequivalent to a listed drug if—

（B）如果满足以下情况，仿制药可以被认定为与对照药生物等效-

(i) the rate and extent of absorption of the drug do not show a significant difference from the rate and extent of absorption of the listed drug when administered at the same molar dose of the therapeutic ingredient under similar experimental conditions in either a single dose or multiple doses; or

（i）单倍或者多倍剂量，在相同的实验条件下，服用相同摩尔量的治疗成分，仿制药的吸收速率和相对量，与对照药相比不存在重大差异；或者

(ii) the extent of absorption of the drug does not show a significant difference from the extent of absorption of the listed drug when administered at the same molar dose of the therapeutic ingredient under similar experimental conditions in either a single dose or multiple doses and the difference from the listed drug in the rate of absorption of the drug is intentional, is reflected in its proposed labeling, is not essential to the attainment of effective body drug concentrations on chronic use, and is considered medically insignificant for the drug.

（ii）单倍或者多倍剂量，在相同的实验条件下，服用相同摩尔量的治疗成分，仿制药的吸收程度和对照药不存在重大差异，并且与对照药吸收速率的差异是特意的，吸收速率已经在标签上注明，对长期使用达到有效的体内浓度也不是必要的因素，并且在医学上是无关紧要的一个因素。

(C) For a drug that is not intended to be absorbed into the bloodstream, the Secretary may establish alternative, scientifically valid methods to show bioequivalence if the alternative methods are expected to detect a significant difference between the drug and the listed drug in safety and therapeutic effect.

（C）对于不进入血液循环的药物，卫生部将建立另一种，科学有效的方法显示药品的生物利用度，如果该方法能够检测仿制药和对照药在安全性和治疗效果方面的重大差异。

(9) The Secretary shall, with respect to each application submitted under this subsection, maintain a record of—

（9）对于按照本部分递交的申请，卫生部应当有一份包含以下信息的记录-

(A) the name of the applicant, 申请人姓名

(B) the name of the drug covered by the application,申请涵盖的药品名称

(C) the name of each person to whom the review of the chemistry of the application was assigned and the date of such assignment, and

指定审核化学部分内容的人员名单以及指定的日期

(D) the name of each person to whom the bioequivalence review for such application was assigned and the date of such assignment.

指定审核生物等效性内容的人员名单以及指定的日期

The information the Secretary is required to maintain under this paragraph with respect to an application submitted under this subsection shall be made available to the public after the approval of such application.

申请被批准后，卫生部按照本部分要求维护记录所需的与申请相关的信息应当向公众发布。

(10)(A) If the proposed labeling of a drug that is the subject of an application under this subsection differs from the listed drug due to a labeling revision described under clause (i), the drug that is the subject of such application shall, notwithstanding any other provision of this chapter, be eligible for approval and shall not be considered misbranded under section 352 of this title if—

(10)(A)如果因为（i）所描述的情况，仿制药的标签进行了升级，与对照药的标签有差异，所申请的药品，无论其他条款有何规定，如果能满足以下条件，仍有资格获得批准并且不应当视作贴错标签，-

(i) the application is otherwise eligible for approval under this subsection but for expiration of patent, an exclusivity period, or of a delay in approval described in paragraph (5)(B)(iii), and a revision to the labeling of the listed drug has been approved by the Secretary within 60 days of such expiration;

（i）申请是由于专利未过期，市场专营期或者专利诉讼延迟而未得到批准，并且升级的对照药的标签已经在这些期限到期前60天内被卫生部批准；

(ii) the labeling revision described under clause (i) does not include a change to the ‘‘Warnings’’ section of the labeling;

（ii）（i）中所描述的标签的升级不包括 “警告”部分的变更。

(iii) the sponsor of the application under this subsection agrees to submit revised labeling of the drug that is the subject of such application not later than 60 days after the notification of any changes to such labeling required by the Secretary; and

（iii）申请人同意自接到任何变更的通知之日起，按照卫生部的需求，在60日内递交升级的标签并且

(iv) such application otherwise meets the applicable requirements for approval under this subsection.

（iv）申请符合本章节其他适用的批准要求

(B) If, after a labeling revision described in subparagraph (A)(i), the Secretary determines that the continued presence in interstate commerce of the labeling of the listed drug (as in effect before the revision described in subparagraph  (A)(i)) adversely impacts the safe use of the drug, no application under this subsection shall be eligible for approval with such labeling.

（B）如果，按照（A）（i）的要求完成了标签的升级，卫生部判断对照药旧标签继续在州际贸易中存在将对药品安全使用产生不利影响，包含旧标签的申请经被拒绝批准。

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