【转载】314 Part C 简略申请（314.91--314.93）

【转载】314 Part C 简略申请（314.91--314.93）  

2014-10-16 22:52:50|  分类： FDA|举报|字号 [url=]订阅[/url]

本文转载自aimerjiaer《314 Part C 简略申请（314.91--314.93）》http://zhuyujiao1972.blog.163.com/blog/static/986947272014916105250971/
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[Code of Federal Regulations]联邦法规
6 z# q) r9 {: C8 @9 Z[Title 21, Volume 5]标题21，卷5
0 D+ |3 V$ S# ?+ T, W2 h- ^[Revised as of April 1, 2014]2014年4月1日修订
[CITE: 21CFR314]
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  |. h2 B2 f( u7 hTITLE 21--FOOD AND DRUGS
标题21--食品和药品
& B9 |+ O$ c- C* e. i5 o+ p8 ]9 dCHAPTER I--FOOD AND DRUG ADMINISTRATION
章节 I--食品药品监督管理局
DEPARTMENT OF HEALTH AND HUMAN SERVICES
$ O! ^7 H9 {4 v$ |) Q健康与人类服务部（DHHS）
5 m- r$ Q( ^+ e# T5 s1 `6 e" x. SSUBCHAPTER D--DRUGS FOR HUMAN USE
副章节 D—人用药
+ I8 m$ g" W+ o. H7 a/ @PART 314 APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
PART 314 FDA批准新药上市的申请
: _! w  n) T) T' w5 X6 CSubpart C--Abbreviated Applications
Subpart C—简略申请
Sec. 314.92 Drug products for which abbreviated applications may be submitted.
Sec. 314.92 药品的简略申请
(a) Abbreviated applications are suitable for the following drug products within the limits set forth under 314.93:
" D3 x8 `* _1 Z7 H(a) 按照314.93的规定，以下产品适用于简略申请：
(1) Drug products that are the same as a listed drug. A "listed drug" is defined in 314.3. For determining the suitability of an abbreviated new drug application, the term "same as" means identical in active ingredient(s), dosage form, strength, route of administration, and conditions of use, except that conditions of use for which approval cannot be granted because of exclusivity or an existing patent may be omitted. If a listed drug has been voluntarily withdrawn from or not offered for sale by its manufacturer, a person who wishes to submit an abbreviated new drug application for the drug shall comply with 314.122.
(1) 与上市药一致的药品  “上市药”在314.3部分有定义。为了确定ANDA的适用性，前一句中“same as”指的是药品的活性成分，剂型，规格，给药途径和使用条件与上市药一致（独占期或者专利保护的使用条件除外）。如果上市药已经被生产商自动撤市或者不出售，ANDA按照314.122的要求递交。
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' m  \. R) ?' U- b& m(2) [Reserved]保留部分

(3) Drug products that have been declared suitable for an abbreviated new drug application submission by FDA through the petition procedures set forth under 10.30 of this chapter and 314.93.
(3) 根据本章节10.30和314.93规定，FDA已经公告的适用于通过请愿方式递交ANDA的药品。
! p& V' \* y- i" Z(b) FDA will publish in the list listed drugs for which abbreviated applications may be submitted. The list is available from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402, 202-783-3238.
(b) 可以递交简略申请的上市药，FDA将列在上市药的清单中。清单可以从文档管理处获得，U.S. Government Printing Office, Washington, DC 20402, 202-783-3238
[57 FR 17983, Apr. 28, 1992, as amended at 64 FR 401, Jan. 5, 1999]

% h" S1 b$ K) D4 }Sec. 314.93 Petition to request a change from a listed drug.
. Q% S7 L1 l  D: O# e  `- u9 cSec. 314.93 请愿途径申请上市药的变更
; g0 Z2 }& O1 }8 ~! ^% P(a) The only changes from a listed drug for which the agency will accept a petition under this section are those changes described in paragraph (b) of this section. Petitions to submit abbreviated new drug applications for other changes from a listed drug will not be approved.
0 O& U5 q- ?* M2 G. H- U(a) 当局只接受本部分段落(b)中列出的变更的请愿。ANDA中其他上市药变更的请愿不会被批准。
3 ~- E% }8 H# ^: b(b) A person who wants to submit an abbreviated new drug application for a drug product which is not identical to a listed drug in route of administration, dosage form, and strength, or in which one active ingredient is substituted for one of the active ingredients in a listed combination drug, must first obtain permission from FDA to submit such an abbreviated application.
% Y3 E2 v0 w" n8 u, q(b) ANDA药品的给药途径，剂型，规格与上市药不一致，或者其中一个活性成分替代复方上市药中的活性成分，申请人必须先得到FDA的批准，才能递交这样的简略申请。
(c) To obtain permission to submit an abbreviated new drug application for a change described in paragraph (b) of this section, a person must submit and obtain approval of a petition requesting the change. A person seeking permission to request such a change from a reference listed drug shall submit a petition in accordance with 10.20 of this chapter and in the format specified in 10.30 of this chapter. The petition shall contain the information specified in 10.30 of this chapter and any additional information required by this section. If any provision of 10.20 or 10.30 of this chapter is inconsistent with any provision of this section, the provisions of this section apply.
(c) 为了获得批准递交段落(b)中变更的ANDA，申请人必须递交变更的请愿并获批。申请人寻求RLD变更的，应递交一份符合本章节10.20的请愿，请愿的格式在本章节10.30部分有具体描述。请愿需要包含本章节10.30要求的信息和本部分要求的其他额外信息。本部分条款与10.20或10.30有冲突的，按照本部分条款实施。
(d) The petitioner shall identify a listed drug and include a copy of the proposed labeling for the drug product that is the subject of the petition and a copy of the approved labeling for the listed drug. The petitioner may, under limited circumstances, identify more than one listed drug, for example, when the proposed drug product is a combination product that differs from the combination reference listed drug with regard to an active ingredient, and the different active ingredient is an active ingredient of a listed drug. The petitioner shall also include information to show that:
(d) 请愿应指定上市药并且包括请愿产品的标签复印件，以及上市药已批准标签的复印件。在某些情况下，请愿指定的上市药可能不止一个，比如请愿药品是一个复方制剂，与复方RLD相比，其中一个活性成分不同，并且该不同的活性成分是另一个上市药的活性成分。请愿还需要包含信息证明以下内容：
(1) The active ingredients of the proposed drug product are of the same pharmacological or therapeutic class as those of the reference listed drug.
; r  p( z( J7 l(1) 请愿药品的活性成分与RLD的活性成分是相同的药理和治疗领域。
( ?8 ]: O: S( \; F6 g7 X(2) The drug product can be expected to have the same therapeutic effect as the reference listed drug when administered to patients for each condition of use in the reference listed drug's labeling for which the applicant seeks approval.
(2)按照RLD标签上申请人寻求批准的使用条件给病人服用，请愿药品和RLD可以达到相同的治疗效果。
(3) If the proposed drug product is a combination product with one different active ingredient, including a different ester or salt, from the reference listed drug, that the different active ingredient has previously been approved in a listed drug or is a drug that does not meet the definition of "new drug" in section 201(b) of the act.
(3) 如果请愿药品是复方制剂，并且有一个活性成分与RLD的不同，包括不同的脂类或者盐类，该不同的活性成分已在其他上市药中被批准，或者不属于“新药”的范畴。
% S8 e" x# F- X3 }(e) No later than 90 days after the date a petition that is permitted under paragraph (a) of this section is submitted, FDA will approve or disapprove the petition.
(e)按照本部分段落(a)允许递交的请愿，自递交之日起90日内，FDA将作出是否批准的决定
. w& j! u! U3 i0 u1 K6 d9 }7 U(1) FDA will approve a petition properly submited under this section unless it finds that:
: `' ~: x6 K4 @(1)FDA将批准请愿，除非发现以下问题：
5 \6 ^$ J% }; _1 V  m  {(i) Investigations must be conducted to show the safety and effectiveness of the drug product or of any of its active ingredients, its route of administration, dosage form, or strength which differs from the reference listed drug; or
* {  z2 u6 b/ S6 k2 N(1) FDA认为必须实施动物实验和临床研究，才能保证请愿药品或者它与上市药不同的活性成分，给药途径，剂型和规格的安全性和有效性。
6 Z* l; G) O  J* S# n(ii) For a petition that seeks to change an active ingredient, the drug product that is the subject of the petition is not a combination drug; or
! ?! ^) |, @* ]+ Y(ii)非复方制剂，请愿变更活性成分，或者
/ k5 u' n3 u' q0 L8 }; U6 i(iii) For a combination drug product that is the subject of the petition and has an active ingredient different from the reference listed drug:
0 h  F- G3 b( k+ m; C- {(iii) 请愿的复方制剂，其中一个活性成分与RLD不同：
: G5 @, O& e1 g  l(A) The drug product may not be adequately evaluated for approval as safe and effective on the basis of the information required to be submitted under 314.94; or
(A) 根据314.94递交的信息，不能充分评估审批药品的安全性和有效性；或者
(B) The petition does not contain information to show that the different active ingredient of the drug product is of the same pharmacological or therapeutic class as the ingredient of the reference listed drug that is to be changed and that the drug product can be expected to have the same therapeutic effect as the reference listed drug when administered to patients for each condition of use in the listed drug's labeling for which the applicant seeks approval; or
(B)请愿中没有包含信息可以证明不同的活性成分与RLD中被变更的活性成分是相同的药理或治疗领域，并且不能证明按照RLD标签上申请人寻求批准的使用条件给病人服用，请愿药品和RLD可以达到相同的治疗效果。
4 H" K5 z! A- `& Q& }/ l% H2 u(C) The different active ingredient is not an active ingredient in a listed drug or a drug that meets the requirements of section 201(p) of the act; or
(C) 不同的活性成分不是某上市药的活性成分，或者该活性成分属于“新药”的范畴；或者
& A5 K% q/ O/ t8 O(D) The remaining active ingredients are not identical to those of the listed combination drug; or
(D) 其他活性成分与复方RLD中的其他活性成分不一致；或者
(iv) Any of the proposed changes from the listed drug would jeopardize the safe or effective use of the product so as to necessitate significant labeling changes to address the newly introduced safety or effectiveness problem; or
(iv) 任何上市药的变更将危及到请愿药品安全有效的使用，导致需要对标签做重大变更以解决新引入的安全性有效性问题；或者
(v) FDA has determined that the reference listed drug has been withdrawn from sale for safety or effectiveness reasons under 314.161, or the reference listed drug has been voluntarily withdrawn from sale and the agency has not determined whether the withdrawal is for safety or effectiveness reasons.
(v) FDA因RLD安全性有效性的原因决定按照314.161将RLD撤市，或者RLD厂家自动撤市并且当局还未判定撤市是否是安全性有效性的原因。
(2) For purposes of this paragraph, "investigations must be conducted" means that information derived from animal or clinical studies is necessary to show that the drug product is safe or effective. Such information may be contained in published or unpublished reports.
(2) 就本段落而言，“必须实施的研究”指的是来源于动物或者临床研究的信息对于药品安全性有效性的证明是必需的。上述信息可能包含在发表或未发表的报告中。
; n/ h+ r3 R# c(3) If FDA approves a petition submitted under this section, the agency's response may describe what additional information, if any, will be required to support an abbreviated new drug application for the drug product. FDA may, at any time during the course of its review of an abbreviated new drug application, request additional information required to evaluate the change approved under the petition.
(3) 如果FDA批准了请愿，当局可能会在回复中描述支持ANDA将需要哪些额外的信息。FDA在审核ANDA过程中，任何时间段都有可能要求申请人提供额外的信息评估以请愿形式得到批准的变更。
2 `% w7 l. D/ I* q2 \" l+ ?* q(f) FDA may withdraw approval of a petition if the agency receives any information demonstrating that the petition no longer satisfies the conditions under paragraph (e) of this section.
6 a, u& Z) q5 @  K$ W- d) D(f) FDA收到任何信息，可以证实已批准请愿不再满足本部分段落(e)中条款的，FDA将撤销批准。
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