POLICY AND PROCEDURES
Office of Pharmaceutical Quality
NDA Classification Codes
焗油膏和护发素的区别
Table of Contents
PURPOSE (1)
BACKGROUND (1)
POLICY (1)
NDA Classification Codes (2)
RESPONSIBILITIES (7)
REFERENCES (9)
DEFINITIONS (9)
EFFECTIVE DATE (10)
CHANGE CONTROL TABLE (10)
PURPOSE
This MAPP describes the new drug application (NDA) classification code assigned by the Center for Drug Evaluation and Rearch (CDER) to an NDA bad on characteristics of the product in the application. This code was previously referred to as “Chemistry Classification Code.” BACKGROUND
•The NDA classification code provides a way of categorizing new drug applications. The code evolved from both a management and a regulatory need to identify and group
product applications bad on certain characteristics, including their relationships to
products already approved or marketed in the United States. Classifying applications
bad on the characteristics contributes to the management of CDER’s workload,
promotes consistency across review divisions, enables retrospective analysis of trends,
and facilitates planning and policy development.
•The NDA classification codes are not determinative of classification for purpos of exclusivity. The codes are not indicative of the extent of innovation or therapeutic
value that a particular drug reprents.
POLICY
•FDA tentatively assigns an NDA classification code by the filing date for a new application and reasss the code at the time of approval. The reasssment will be
bad upon relationships of the drug product being approved to products already
approved or marketed in the United States at the time of approval. FDA may also
reasss the code after approval.
•FDA can tentatively determine a classification code for an investigational new drug (IND) prior to submission of a marketing application. This can be uful particularly
with regard to whether or not the active ingredient in the IND may be considered to
contain a new molecular entity (NME). Any determination of the chemical type
during the IND stage is performed as part of review and may be revid when the
marketing application is submitted, or upon approval, or after approval.
•When two or more NDAs for the same active ingredient tentatively considered as an NME are submitted by the same applicant and approved at the same time, the
classification is changed for all but one NDA. In this ca, the decision as to which
NDA should be coded Type 1 may depend on factors other than timing. For example,
the NDA with the bulk of the efficacy data could be coded Type 1 and the other
NDA(s) reclassified, generally as Type 3 or Type 5.1
•Generally, only one NDA classification code should be assigned, except that more than one code may be assigned to combination products (e Type 4 and Type 5,
subction 4).
NDA Classification Codes
Type 1 — New Molecular Entity
A Type 1 NDA is for a drug product that contains an NME.2 An NME is an active
ingredient that contains no active moiety that has been previously approved by the
Agency in an application submitted under ction 505 of the Act3 or has been previously marketed as a drug in the United States. A pure enantiomer or a racemic mixture is an
NME only when neither has been previously approved or marketed.
An NDA for a drug product containing an active moiety that has been marketed as a drug in the United States, but never approved in an application submitted under ction 505 of the Act, would be considered Type 7, not Type 1.
An NDA for a drug-drug4 combination product containing an active moiety that is an
NME in combination with another active moiety that had already been approved by the 1 Even though the NDA(s) may be reclassified in this circumstance, the Agency does not consider the active moieties to be previously approved at the time of approval of the NDA(s). The reclassification is made only for administrative purpos.
2 The terms New Molecular Entity (NME) and New Chemical Entity (NCE) are sometimes ud interchangeably; however, they are distinct. An NCE is defined in 21 CFR 314.108(a) as “a drug that contains no active moiety that has been approved by the FDA in any other application submitted under 505(b) of the Act.” The term NME is not defined in the statute or regulations. An NME is an active ingredient that contains no active moiety that has been previously approved by the Agency in an application submitted under ction 505 of the Act or has been previously marketed as a drug in the United States.
3 This applies to applications approved or deemed approved from 1938 to the prent.
4 For example, a drug-drug combination can include a fixed-combination drug product or a co-packaged drug product with two or more active moieties.
FDA would be classified as a new combination containing an NME (Type 1,4).
An active moiety in a radiopharmaceutical (or radioactive drug) which has not been
approved by the FDA or marketed in the United States is classified as an NME.
In addition, if a change in isotopic form (e.g., a change from 131I to 123I, 12C to 13C) results in an active moiety that has never been approved by the FDA or marketed in the United
States, the active ingredient is classified as an NME.
Type 2 — New Active Ingredient
离职感谢领导的话
A Type 2 NDA is for a drug product that contains a new active ingredient, but not an
NME. A new active ingredient includes tho products who active moiety has been
previously approved or marketed in the United States, but who particular ester, salt, or noncovalent derivative of the unmodified parent molecule has not been approved by the
Agency or marketed in the United States, either alone, or as part of a combination
product. Similarly, if any ester, salt, or noncovalent derivative has been marketed first,
the unmodified parent molecule would also be considered a new active ingredient, but not an NME. The indication for the drug product does not need to be the same as that of the already marketed product containing the same active moiety.
If the active ingredient is a single enantiomer and a racemic mixture containing that
enantiomer has been previously approved by the FDA or marketed in the United States,
or if the active ingredient is a racemic mixture containing an enantiomer that has been
previously approved by the FDA or marketed in the United States, the NDA will be
classified as a Type 2.
Type 3 — New Dosage Form
A Type 3 NDA is for a new dosage form of an active ingredient that has been approved or
marketed in the United States by the same or another applicant but in a different dosage
form. (See the Orange Book, Appendix C; or the Electronic Orange Book, Uniform
Terms for examples of dosage forms.) The indication for the drug product does not need to be the same as that of the already marketed drug product. Once a new dosage form has been approved for an active ingredient, subquent applications for the same dosage form and active ingredient should be classified as Type 5.
Type 4 — New Combination
A Type 4 NDA is for a new drug-drug combination of two or more active ingredients.的校园
An application for a new drug-drug combination product may have more than one
银行心得体会classification code if at least one component of the combination is an NME or a new
active ingredient. The new product may be a physical or chemical (e.g., covalent ester or noncovalent derivative) combination of two or more active moieties.
A new physical combination may be two or more active ingredients combined into a
single dosage form, or two or more drug products packaged together with combined
labeling. When at least one of the active moieties is classified as an NME, the NDA is
classified as a Type 1,4 application. When none of the active moieties is an NME, but at
least one is a new active ingredient, the NDA is classified as a Type 2,4 application.
An NDA for an active ingredient that is a chemical combination of two or more
previously approved or marketed active moieties that are linked by an ester bond is
classified as a Type 2,4 application if the active moieties have not been previously
marketed or approved as a physical combination. If the physical combination has been
previously marketed or approved, however, such a product would no longer be
considered a new combination and the NDA would thus be classified as a Type 2. Type 5 — New Formulation or Other Differences (e.g., new indication, new applicant, new manufacturer)
A Type 5 NDA is for a product, other than a new dosage form, that differs from a product
already approved or marketed in the United States becau of one of the following:
1.The product involves changes in inactive ingredients that require either
bioequivalence studies or clinical studies for approval and is submitted as an
original NDA rather than as a supplement by the applicant of the approved
product.
2.The product is a duplicate of a drug product by another applicant (same
active ingredient, same dosage form, same or different indication, or same
combination), and
(a) requires bioequivalence testing (including bioequivalence studies
with clinical endpoints), but is not eligible for submission as a ction
505(j) application; or
(b) requires safety or effectiveness testing becau of novel inactive
ingredients; or
(c) requires full safety or effectiveness testing becau it is:
(i) subject to exclusivity held by another applicant, or
(ii) a product of biotechnology and its safety and/or effectiveness
are not asssable through bioequivalence testing, or
(iii) a crude natural product, or
(iv) ineligible for submission under ction 505(j) becau it
differs in bioavailability (e.g., products with different relea
patterns); or
(d) the applicant has a right of reference to the application.
3.The product contains an active ingredient or active moiety that has been
previously approved or marketed in the United States only as part of a风电行业分析
combination. This applies to active ingredients previously approved or
marketed as part of a physical or chemical combination, or as part of a
mixture derived from recombinant DNA technology or natural sources.
热缩管使用方法4.The product is a combination product that differs from a previously marketed
combination by the removal of one or more active ingredients or by
substitution of a new ester or salt or other noncovalent derivative of an active
ingredient for one or more of the active ingredients. In the latter ca, the
NDA would be classified as a Type 2,5.
5.The product contains a different strength of one or more active ingredients in
a previously approved or marketed combination. A Type 5 NDA would
generally be submitted by an applicant other than the holder of the approved
application for the approved product. A similar change in an approved
product by the applicant of the approved product would usually be submitted
as a supplemental application.
6.The product differs in bioavailability (e.g., superbioavailable or different
controlled-relea pattern) and, therefore, is ineligible for submission as an
abbreviated new drug application (ANDA) under ction 505(j).
7.The product involves a new plastic container that requires safety studies
beyond limited confirmatory testing (e 21 CFR 310.509, Parenteral drug
products in plastic containers, and MAPP 6020.2, Applications for
Parenteral Products in Plastic Immediate Containers).
Type 6 — New Indication or Claim, Same Applicant
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This NDA classification code is no longer ud and is replaced with Type 9 and Type 10.
This classification is retained in the MAPP for historical reasons.
A Type 6 NDA was ud for an NDA received prior to July 27, 2009,5 for a drug product
that duplicates a drug product already approved or marketed in the United States by the
same applicant, except that it is intended for a new indication or claim (same active
moiety or combination of active moieties, same salt(s), ester(s), or other noncovalent
derivative(s), same dosage form, and same formulation (including all ingredients ud in the manufacturing process whether or not they are prent in the final dosage form)). Type 7 — Previously Marketed But Without an Approved NDA
A Type 7 NDA is for a drug product that contains an active moiety that has not been
previously approved in an application, but has been marketed in the United States. This classification applies only to the first NDA approved for a drug product containing this
(the) active moiety(ies).
Type 7 NDAs include, but are not limited to:
河豚干(1)The first post-1962 application for an active moiety marketed prior to 1938.
5 July 27, 2009 is the date of implementation of the Document Archiving, Reporting and Regulatory Tracking System (DARRTS), which made Type
6 obsolete.
