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3 c7 Z3 E3 s# P% Z. W/ R% T2 z- F+ }[Code of Federal Regulations]联邦法规
[Title 21, Volume 5]标题21，卷5
[Revised as of April 1, 2013]2013年4月1日修订
[CITE: 21CFR314]
TITLE 21--FOOD AND DRUGS标题21-食品和药品
CHAPTER I--FOOD AND DRUG
ADMINISTRATION
章节 I –食品和药品监督管理局（FDA）
( a1 A4 T) K9 q( ~ |% [[url=]DEPARTMENT OF HEALTH AND HUMAN SERVICES[/url]
健康与人类服务部（DHHS）
5 x- u W2 G2 n$ \) t% B* ^SUBCHAPTER D--DRUGS FOR HUMAN USE
" f# P( n( f* F2 ^$ ^/ V. b- b8 S副章节 D-人用药品
PART 314 APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
! C |* }5 u0 Z' FPart 314 FDA批准新药上市的申请
o# d2 D7 ]" r- L. ~# A+ qSubpart A--General Provisions
Subpart A—总则
Sec. 314.1 Scope of this part.本部分范围
(a) This part sets forth procedures
and requirements for the submission to, and the review by, the Food and Drug5 P: Y8 E$ v9 C: n }+ W
Administration of applications and abbreviated applications to market a new
drug under section 505 of the Federal Food, Drug, and Cosmetic Act, as well as; ^8 _- R' j6 y; [% t; w
amendments, supplements, and postmarketing reports to them.
（a）本部分阐述了新药和仿制药为了药品的上市，按照《食品，药品，化妆品法》505部分向FDA递交申请以及FDA审核申请的流程和要求，同样包括申请的补充，修订以及售后报告的递交和审核流程以及要求。
(b) This part does not apply to drug
products [url=]subject to licensing[/url] by FDA under the Public Health8 y9 @' U/ q6 D# l+ K9 c
Service Act (58 Stat. 632 as amended (42 U.S.C. 201et seq. )) and subchapter F8 Q+ @/ ~6 p% N3 O4 R
of chapter I of title 21 of the Code of Federal Regulations.
（b）本部分不适用于按照《公共健康服务法》（58+ n% R! z% y9 n L
Stat. 632 as amended (42 U.S.C. 201et seq. )以及联邦法规标题21章节I副章节F被FDA许可的药品。
(c) References in this part to
regulations in the Code of Federal Regulations are to chapter I of title 21,
unless otherwise noted.
（c）除非另外指定，本部分引用的“法规”指的是联邦法规标题21章节I
[50 FR 7493, Feb. 22, 1985, as
amended at 57 FR 17981, Apr. 28, 1992; 64 FR 401, Jan. 5, 1999]
+ i2 {* D0 Y# u1 z" _: n
Sec. 314.2 Purpose.目的
/ _& f$ O) P5 YThe purpose of this part is to3 P! j& ]4 }% F0 `$ A( {8 I5 A
establish an efficient and thorough drug review process in order to: (a)
Facilitate the approval of drugs shown to be safe and effective; and (b) ensure
the disapproval of drugs not shown to be safe and effective. These regulations% p( O! m. W" Z$ @( O. `
are also intended to establish an effective system for FDA's surveillance of
marketed drugs. These regulations shall be construed in light of these
objectives.
本部分的目的在于建立一个有效周密的药品审核流程以实现：（a）促进安全有效的药品获得批准；（b）确保未能保障安全有效的药品不会得到批准。这些法规同时也是为FDA建立一个有效的上市药品的监管系统。这些法规应当根据这些目标进行解释。
Sec. 314.3 Definitions.定义
; B% q. j8 t2 O1 s# _3 {/ G; R(a) The definitions and
interpretations contained in section 201 of the act apply to those terms when
used in this part.
（a）食品药品化妆品法201部分中对术语的定义和诠释同样适用于本部分使用的术语
(b) The following definitions of
terms apply to this part:
（b）本部分使用的术语定义如下：
Abbreviated application means the2 b! p3 Y9 t2 N/ M( l8 g& n
application described under 314.94, including all amendments and supplements to
the application. "Abbreviated application" applies to both an: f1 C& i. E6 ~2 d6 k9 S
abbreviated new drug application and an [url=]abbreviated antibiotic$ p% o+ J5 F: B( V/ j& v; w
application[/url].
简略申请指的是314.94部分描述的申请，包括所有该申请的修订和补充。“简略申请”适用于简略的新药申请和简略抗生素申请。
' W r/ ~+ s5 i' _1 Z eAct means the Federal Food, Drug, and
Cosmetic Act (sections 201-901 (21 U.S.C. 301-392)).
Act是食品药品化妆品法的缩写
8 L( o x; W! T( X2 XApplicant means any person who submits
an application or abbreviated application or an amendment or supplement to them. a# e" Y% ]( @# K2 K ?& t, {/ l
under this part to obtain FDA approval of a new drug or an antibiotic drug and6 }" p8 M' z; ~$ t" t* y
any person who owns an approved application or abbreviated application.
申请者指的是任何为了获得FDA对新药或者抗生素批准，根据本部分的要求递交申请或者简略申请以及修订或者补充的人员，以及任何拥有已批准申请或者简略申请的人员。
Application means the application
described under 314.50, including all amendements and supplements to the
application.
申请指的是314.50部分描述的申请，包括该申请的所有修订和补充。
505(b)(2) Application means an application' d) o& v- G7 v
submitted under section 505(b)(1) of the act for a drug for which the/ I* N) g- C$ C' |/ B
investigations described in section 505(b)(1)(A) of the act and relied upon by
the applicant for approval of the application were not conducted by or for the/ c! {; o# u2 p9 `- F, l! N
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.
[url=]505[/url]（b）(2)申请，指的是按照食品药品化妆品法505（b）（1）部分递交的药品的申请，该申请并未由申请人执行505（b）（1）（A）所描述的，申请批准所依赖的研究，以及申请人并未从已研究人员手中获得参考或者使用研究成果的权力。
Approval letter means a written
communication to an applicant from FDA approving an application or an
abbreviated application.
批准信指的是FDA书面通知申请人申请或者简略申请得到批准的信件
Assess the effects of the change means2 n2 i! j( L2 |, m
to evaluate the effects of a manufacturing change on the identity, strength,
quality, purity, and potency of a drug product as these factors may relate to9 p0 ?8 j$ d: }( X3 B9 _' w
the safety or effectiveness of the drug product.
评估变更的影响，指的是评估生产变更对于药品性质，规格，质量，纯度和含量的影响，这些因素可能与药品的安全性和有效性相关。
[url=]Authorized generic drug[/url] means! H( F7 T0 u3 \" P1 _# b: Z& s
a listed drug, as defined in this section, that has been approved under section- q' K+ Y) F8 Z
505(c) of the act and is marketed, sold, or distributed directly or indirectly
to retail class of trade with labeling, packaging (other than repackaging as
the listed drug in blister packs, unit doses, or similar packaging for use in
institutions), product code, labeler code,
trade name, or trademark that differs from that of the listed drug.
[url=]授权仿制药[/url]指的是本部分定义的上市药品，已经按照505(c)的要求得到批准，并且已经上市，直接或者间接销售，分销到零售类，拥有标签，包转（铝塑包装，单剂量的原研药进行重新包装，或者用于事业单位使用而做的类似包装除外），产品代码，厂家代码，商品名，或者不同于原研药的商标。
. A# w: y; t) J) L5 @- L[url=]Class 1( ^2 t3 F; R$ U) s" q
resubmission means the resubmission of an$ F' B. R3 I* c+ I! Z2 o
application or [/url][url=]efficacy supplement[/url], following receipt of a complete response letter, that contains one0 N5 H5 e! b- f8 k
or more of the following: Final printed labeling, draft labeling, certain
safety updates, stability updates to support provisional or final dating
periods, commitments to perform postmarketing studies (including proposals for# | s! C3 ]# L' A
such studies), assay validation data, final release testing on the last lots) C2 k( _) Y+ e% A
used to support approval, minor reanalyses of previously submitted data, and5 a/ |" I3 l( n$ k W
other comparatively minor information.
一类重新递交指的是接收到CR不足信之后重新递交申请或者有关疗效的修订，包括一个或者多个以下的内容：最终印刷版的标签，标签草稿，某些药品安全方面的更新，稳定性数据的更新以支持临时的或者最终的约定期限， 执行上市后药品稳定性研究的承诺（包括该研究的方案），含量验证报告，申报批次的放行检测，对之前已递交数据的小的再分析，以及其他相对次要的信息。
Class 2 resubmission means the& J) [5 l1 J5 L
resubmission of an application or efficacy supplement, following receipt of a8 W# p1 `& q% K$ C3 J# E3 W$ ]
complete response letter, that includes any item not specified in the
definition of "Class 1 resubmission," including any item that would# F3 p9 J& t6 |/ _ u9 X
require presentation to an advisory committee.
2类重新递交指的是接收到CR不足信之后重新递交申请或者与疗效相关的修订，包括任何“1类重新递交”中没有具体指出的内容，以及任何需要向咨询委员会呈现的内容。
! q! D$ t, q9 Q1 ?Complete response letter means a written6 ~9 i; y0 y3 q- i
communication to an applicant from FDA usually describing all of the( y6 ?% h) [5 g7 `) e0 n2 A# ~
deficiencies that the agency has identified in an application or abbreviated
application that must be satisfactorily addressed before it can be approved.
CR不足信指的是FDA书面通知申请人的，描述所有当局已在申请或者简略申请中确认的缺陷项的信件，这些缺陷项必须得到圆满的解决，才能批准申请。
0 N$ h( N& n9 N% {Drug product means a finished dosage
form, for example, tablet, capsule, or solution, that contains a drug
substance, generally, but not necessarily, in association with one or more
other ingredients.
药品指的是完成的剂型，例如，片剂，胶囊剂，或者溶液，包含一种原料药，一般情况下，但不是必须的，和一种或者一种以上的辅料一起制成。
2 V3 X; D2 _5 b: e+ H; I( nDrug substance means an active
ingredient that is intended to furnish pharmacological activity or other direct( u3 a% F4 u" i+ _
effect in the diagnosis, cure, mitigation, treatment, or prevention of disease% g% X3 U: Q8 }
or to affect the structure or any function of the human body, but does not- j/ G0 I& k, c) }: k# [4 _3 x, b9 z
include intermediates use in the synthesis of such ingredient.
原料药指的是一种用于在疾病的诊断，治疗，缓解或预防过程中产生药理作用或者其他直接的效果，或者用于影响人体的结构或者功能的活性成分，但是不包括原料药合成过程中使用的中间体。
7 W! q" ]( [4 _8 J6 t0 J* Y[url=]Efficacy supplement[/url] means a+ l l: X9 v+ b; } B9 ]
supplement to an approved application proposing to make one or more related/ N6 _ F. N1 y. ]0 J' t; Z
changes from among the following changes to product labeling:
有关疗效的修订指的是针对已批准申请递交的，对产品标签所做包括在以下内容中的一个或者多个变更：
(1) Add or modify an indication or [url=]claim[/url];
3 [% S; ?+ n' \* i（1）增加或者修订一个适应症或者权利要求
(2) Revise the dose or dose regimen;
4 b3 h2 D6 L: o! w8 J3 s（2）修订剂量或者给药方案
(3) Provide for a new route of7 F9 \( ], X; a9 A. H7 S0 ^/ R
administration;
（3）提交新的给药途径
(4) Make a comparative efficacy! Y. c9 {7 s# I( p3 c
claim naming another drug product;
（4）做一个相对有效的声明，命名另一个药品
(5) Significantly[url=] alter the intended% ]- n, J" D' }# X* @2 U
patient population[/url];
（5）显著改变适用的病患人群
( B8 A. ]8 L' C9 Q, @+ @4 {( i(6) Change the marketing status from
prescription to over-the-counter use;
（6）市场状态由处方药变更为OTC药
% z' I1 t. O* j0 G0 Q7 ]3 ?(7) Provide for, or provide evidence; A/ c! V1 b2 G/ M4 n; h- N
of effectiveness necessary for, the traditional approval of a product' P( c/ S! s9 Q/ p8 T+ ^& g: u( Y
originally approved under subpart H of part 314; or
（7）对原来按照314 H章节批准的药品提供有效性的证明用于产品传统的批准，或者
9 n$ o1 G% G; h(8) Incorporate other information- X% r G G6 _/ y+ {9 j8 Z
based on at least one adequate and well-controlled clinical study.
（8）结合其他信息，基于至少一个充分且控制良好的临床研究
FDA means the Food and Drug
Administration.
FDA是食品药品监督管理局的缩写
Listed drug means a new drug product! w# A+ q8 {2 L+ Q3 R2 I9 O' g
that has an effective approval under section 505(c) of the act for safety and7 i9 s! N2 |, K8 J
effectiveness or under section 505(j) of the act, which has not been withdrawn
or suspended under section 505(e)(1) through (e)(5) or (j)(5) of the act, and
which has not been withdrawn from sale for what FDA has determined are reasons
of safety or effectiveness. Listed drug status is evidenced by the drug
product's identification as a drug with an effective approval in the current
edition of FDA's "Approved Drug Products with Therapeutic Equivalence7 n0 _( Y Q9 j0 |
Evaluations" (the list) or any current supplement thereto, as a drug with. I' o3 ?) A# X. o. I B0 x
an effective approval. A drug product is deemed to be a listed drug on the date, k4 G$ b+ t, A* |8 D' T
of effective approval of the application or abbreviated application for that4 J6 n2 e+ z! P G( R
drug product.
上市药指的是一种新药，其安全性和有效性已经按照505（c）或者505(j)的要求得到有效的批准，并未出现505（e）（1）至（e）（5）或者（j）（5）的情况被撤销或者废除，并且也没有因为安全性有效性的问题被FDA撤市。上市药的状态是在药品得到有效批准之后，显示在现行版的FDA“具有等效性治疗评估的已批准药品”(是一份清单)或者任何现行的修订中。药品在其申请或者简略申请得到有效批准的当日被定位为上市药。
Newly acquired information means data,8 B3 T2 }* S/ A9 i1 w/ _: Z i& L
analyses, or other information not previously submitted to the agency, which
may include (but are not limited to) data derived from new clinical studies,
reports of adverse events, or new analyses of previously submitted data (e.g., [url=]meta-analyses[/url])3 U8 ?- }8 F& z# A( A
if the studies, events or analyses reveal risks of a different type or greater; e9 j( H k% `: E4 e* I e8 F$ ?
severity or frequency than previously included in submissions to FDA.
新获得的信息指的是先前未递交给当局的数据，分析或者其他信息，可能包括（但不限于）新的来源于临床研究的数据，不良反应报告，或者对先前所递交数据的再分析（例如荟萃分析），如果上述研究，事件或者重分析揭示了比之前递交给FDA信息不同类型，或者更加严重或更频繁的风险。
- U5 A4 Z u, X" r1 bOriginal application means a pending0 q7 `0 q% {2 T* M( n; @$ C% I
application for which FDA has never issued a complete response letter or
approval letter, or an application that was submitted again after FDA had
refused to file it or after it was withdrawn without being approved.
原始申请指的是待批准的，FDA未发布CR不足信或者批准信的申请，或者指的是FDA拒绝备案或者未得到批准被撤回之后重新递交的申请。
Reference listed drug means the listed
drug identified by FDA as the drug product upon which an applicant relies in
seeking approval of its abbreviated application.
参照药指的是FDA指定的上市药，提供简略申请的申请人为了得到批准需要参照的药品。
9 i7 t5 K' x: _1 ]6 ^& R" y; dResubmission means submission by the) j$ B/ n6 J- J4 u/ q H( P
applicant of all materials needed to fully address all deficiencies identified0 s6 b( r2 }3 {3 v) p0 {( k$ u
in the complete response letter. An application or abbreviated application for
which FDA issued a complete response letter, but which was withdrawn before
approval and later submitted again, is not a resubmisson
重新递交指的是申请人为了完满解决CR不足信上的缺陷项而做的递交。FDA已经发布CR不足信的申请或者简略申请，在批准前被撤回，之后再次递交申请的，不能作为重新递交。.
1 H# J. K# ~% o1 g, [; n[url=]Right of reference or use[/url]# J. a2 [6 U# {
means the authority to rely upon, and otherwise use, an investigation for the
purpose of obtaining approval of an application, including the ability to make
available the underlying raw data from the investigation for FDA audit, if
necessary.
参照或者使用的权限指的是为了获得申请的批准，依据或者使用一份研究的权限，如若必要，包括能够使用FDA从调查审计所得的原始数据。
. B+ C/ ^* v/ b8 t; F( FSpecification means the quality standard
(i.e. , tests, analytical procedures, and acceptance criteria) provided in an1 a& q; y( r, B8 e, p# G
approved application to confirm the quality of drug substances, drug products,
intermediates, raw materials, reagents, components, in-process materials,
container closure systems, and other materials used in the production of a drug
substance or drug product. For the purpose of this definition, acceptance( V! ^# E' B S0 l8 p7 @/ U' K
criteria means numerical limits, ranges, or other criteria for the tests
described.
质量标准指的是已批准申请中提供的能够确保原料药，成品，中间体，原始材料，试剂，化学成分，中间控制材料，包装密闭系统以及其他在原料药或者成品生产过程中使用到的材料质量的规范（例如检测项目，分析方法，以及接受限度）。按照本部分的定义，接受限度指的是数量限度，范围或者其他检测描述的限度。
9 { I' i8 y1 r5 g; p" W5 {- IThe list means the list of drug products
with effective approvals published in the current edition of FDA's publication
"Approved Drug Products with Therapeutic Equivalence Evaluations" and
any current supplement to the publication.
清单指的是已得到有效批准的，在FDA现行版“具有等效性治疗评估的已批准药品”或者任何现行的修订上发布的药品的清单。
[50 FR 7493, Feb. 22, 1985, as amended at 576 L( p# Q. X! x& Z' z
FR 17981, Apr. 28, 1992; 69 FR 18763, Apr. 8, 2004; 73 FR 39607, July 10, 2008;
73 FR 49609, Aug. 22, 2008; 74 FR 37167, July 28, 2009]
$ w8 ~4 p; V8 O* [& N' `
Authority: 21 U.S.C. 321, 331, 351,
352, 353, 355, 356, 356a, 356b, 356c, 371, 374, 379e.
Source: 50 FR 7493, Feb. 22, 1985,# r* S4 v( c4 ?0 l* R
unless otherwise noted.
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