FDA 发布 MAPP 5021.5 Rev. 1，更新设施类重大缺陷转轻微重分类请求评估程序
MAPP 5021.5 Assessment of Facility-Based Deficiency Major-to-Minor Reclassification Requests
FDA 药品质量办公室发布 MAPP 5021.5 Rev. 1，更新设施类重大缺陷转轻微重分类请求的评估政策与程序，修订版自 2024 年 1 月 15 日生效。
文件说明了 FDA 对设施类重大缺陷降级请求的受理条件与审评流程，并列出 GDUFA III 目标审评时限。
PDF 文字版；图形和原始排版请参阅官方 PDF。
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MANUAL OF POLICIES AND PROCEDURES
CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 5021.5 Rev. 1
POLICY AND PROCEDURES
OFFICE OF PHARMACEUTICAL QUALITY
Assessment of Facility-Based Deficiency Major-to-Minor Reclassification Requests
Table of Contents
PURPOSE ................................................................................... 1
BACKGROUND......................................................................... 2
POLICY ...................................................................................... 2
RESPONSIBILITIES ................................................................ 4
PROCEDURES .......................................................................... 6
EFFECTIVE DATE ................................................................. 11
CHANGE CONTROL TABLE ............................................... 11
ATTACHMENT: Generic Drug User Fee Amendments
Submission Types and Goal Dates .................................12
PURPOSE
• This MAPP describes the policies and procedures used in the Office of Pharmaceutical
Quality (OPQ), the Office of Compliance, and the Office of Generic Drugs (OGD) for
the assessment of requests for reclassification of facility-based major complete
response (CR) letter amendments (referred to as facility-based deficiency major-to-
minor reclassification requests elsewhere) for original abbreviated new drug
applications (ANDAs) and associated prior approval supplements (PASs).
• This MAPP applies to reclassification requests received as part of a single amendment
that consists of both a reclassification request for facility-based deficiencies 1 and a
response to a CR letter in which the only major deficiency or deficiencies in the CR
letter resulted from a facility inspection(s) or assessment.
• This MAPP applies only to requests for major-to-minor reclassifications for CR letters
issued on or after October 1, 2022 (the implementation date of the Generic Drug User
Fee Amendments of 2022 program (GDUFA III)). 2
1
There could be more than one official action indicated for a facility issue leading to a major complete response.
2
See the GDUFA III commitment letter titled “Reauthorization Performance Goals and Program Enhancements
Fiscal Years 2023-2027” available on the FDA website at https://www.fda.gov/media/153631/download.
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MANUAL OF POLICIES AND PROCEDURES
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BACKGROUND
• The Generic Drug User Fee Amendments of 2012 (GDUFA I) 3 amended the Federal
Food, Drug, and Cosmetic Act to authorize FDA to assess and collect user fees to
provide FDA with resources 4 to help ensure patients have access to quality, affordable,
safe, and effective generic drugs. GDUFA fee resources bring greater predictability
and timeliness to the review of generic drug applications. GDUFA has been
reauthorized every 5 years to continue FDA’s ability to assess and collect GDUFA
fees, and this user fee program has been reauthorized two times since GDUFA I, most
recently in the Generic Drug User Fee Amendments of 2022. 5 As described in the
GDUFA III commitment letter applicable to this latest reauthorization, 6 FDA has
agreed to performance goals and program enhancements regarding aspects of the
generic drug assessment program that build on previous authorizations of GDUFA.
New enhancements to the program are designed to maximize the efficiency and utility
of each assessment cycle, with the intent of reducing the number of assessment cycles
for ANDAs and facilitating timely access to generic medicines for American patients.
• In accordance with the GDUFA III commitment letter, when OPQ and OGD staff
receive and accept an amendment that consists of a facility-only major-to-minor
reclassification request and a response to the CR letter, they work collaboratively to
determine whether to grant or deny the request.
POLICY
• FDA will accept for review a request for reclassification from major to minor if:
‒ The CR letter was issued on or after October 1, 2022 (the implementation date of
GDUFA III). 7
‒ The reclassification request is submitted with a CR letter response amendment in a
single submission.
‒ The facility issue is the only major deficiency.
3
Title III of the Food and Drug Administration Safety and Innovation Act, Public Law 112-144.
4
User fees are available for obligation in accordance with appropriations Acts.
5
Enacted as Title III of Division F (the FDA User Fee Reauthorization Act of 2022) of the Continuing
Appropriations and Ukraine Supplemental Appropriations Act, 2023.
6
See footnote 2.
7
Ibid.
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MANUAL OF POLICIES AND PROCEDURES
CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 5021.5 Rev. 1
‒ The CR letter’s major amendment classification is based on observations from a
surveillance inspection (e.g., official action indicated (OAI) classification of a
facility from a surveillance inspection). This includes surveillance inspections
conducted by foreign regulatory authorities where the information is shared under
a mutual recognition agreement. 8
‒ The reclassification request is easily identified in the cover letter for the
amendment submitted in response to the CR letter.
‒ FDA determines that the words “Facility-Only Reclassification Request” are
included in the submission.
‒ FDA verifies that the submission includes one of the following:
The voluntary action indicated (VAI) or the no action indicated (NAI) current
good manufacturing practice (CGMP) classification letter issued by FDA to the
facility or facilities subsequent to the OAI classification referenced in the CR
letter 9
If the OAI facility or facilities are being withdrawn, a statement verifying that
the facility or facilities are being withdrawn and that the withdrawn 10 facility or
facilities did not generate data to support a regulatory action (e.g., exhibit
batches, stability batches)
‒ The CR letter is less than 1 year old 11 (from the date the CR letter was signed), or
it is more than 1 year old and one of the following applies:
The product is on the drug shortage list or is a public health emergency
product.
The facility deficiency is the only deficiency in the CR letter (i.e., the facility
issue is the only (i.e., single) major deficiency, and there are no minor
deficiencies).
8
Mutual recognition agreements between FDA and foreign regulatory authorities allow drug inspectors to rely
on information from drug inspections conducted within each other’s borders (available at
https://www.fda.gov/international-programs/international-arrangements/mutual-recognition-agreement-mra).
9
See Q5 of the Questions and Answers: Integration of FDA Facility Evaluation and Inspection Program for
Human Drugs: A Concept of Operations FDA web page (available at
https://www.fda.gov/drugs/pharmaceutical-quality-resources/questions-and-answers-integration-fda-facility-
evaluation-and-inspection-program-human-drugs-concept).
10
When a facility is withdrawn from an application, data generated by that facility can no longer serve as the
primary basis of approval (see 21 CFR 314.94), even if the data remains in the electronic common technical
document as supportive information.
11
See Section II.C.6. of the GDUFA III commitment letter.
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• If accepted for review based on the above criteria, FDA will grant the request for
reclassification only when FDA determines that the facility issues have been addressed
(e.g., facility has been classified as an NAI or a VAI), and there is no need for an
inspection or an alternative tool to resolve facility issues for the subject drug. 12
• FDA will generally deny a request for reclassification from major to minor if:
‒ The facility CR deficiency was issued based on an inspection other than a
surveillance inspection or assessment (e.g., a withhold recommendation based on a
preapproval inspection (PAI) or the use of alternative tools). 13
‒ The facility deficiency has not been adequately resolved for the subject drug (e.g.,
FDA intends to conduct additional follow-up to verify that a corrective and
preventive action(s) plan(s) was appropriate and fully implemented).
‒ The facility or facilities that are the subject of the major deficiency are being
withdrawn and generated data to support a regulatory action. In such cases,
because data from those facilities can no longer serve as the primary basis of
approval, FDA will need to assess the impact of the withdrawal or withdrawals on
the completeness of the application. This assessment will require significant time
and resources.
‒ The submission does not include the VAI or the NAI CGMP classification letter
issued by FDA.
RESPONSIBILITIES
OGD Responsibilities
• The Office of Regulatory Operations (ORO) will:
For OGD-Managed Submissions:
‒ Triage the facility-only major-to-minor reclassification request and assign it to
OPQ’s Office of Program and Regulatory Operations (OPRO).
12
In certain cases, the Office of Pharmaceutical Quality should confirm with the Office of Manufacturing
Quality in the Office of Compliance to ensure that there is no need for an inspection or use of an alternative tool
to evaluate a facility before reclassification.
13
See the draft guidances for industry Conducting Remote Regulatory Assessments Questions and Answers (July
2022) and Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications
(September 2023). When final, these guidances will represent the FDA’s current thinking on this topic. For the
most recent version of a guidance, check the FDA guidance web page at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents.
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‒ Draft a formal correspondence that includes acknowledgment of the
reclassification request and issue it to the applicant.
‒ Provide an update to the OPQ assessment team on the prioritization decision that
determines whether the request has a 30- or 60-day decisional period (referred to
as decisional period elsewhere).
‒ Draft the final grant or deny decision and issue it to the applicant.
OPQ Responsibilities
• OPRO will:
‒ Assign the facility-only major-to-minor reclassification request to the regulatory
business process manager (RBPM).
For OGD-Managed Submissions:
The RBPM will:
Assign the reclassification request and notify OPQ’s Office of
Pharmaceutical Manufacturing Assessment (OPMA) to evaluate the
reclassification request.
Review the rationale for OPMA’s grant or deny decision.
For OPQ-Managed Requests for Chemistry, Manufacturing, and Controls
Supplements:
The RBPM will:
Draft a formal correspondence that includes acknowledgment of the
reclassification request and issue it to the applicant.
If applicable, provide an update to the OPQ assessment team on the
prioritization decision that determines whether the request has a 30- or 60-
day decisional period.
Draft the final grant or deny decision and issue it to the applicant.
• OPMA will:
‒ Confirm the current status of the facility or facilities identified in the
reclassification request and determine whether to grant or deny the request where
the facility or facilities are not being withdrawn.
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‒ Confirm that the facility did not manufacture or conduct analyses associated with
one or more batches that are intended to support approval of the application where
the facility or facilities are being withdrawn.
‒ If the reclassification request is denied, provide the rationale to the RBPM to
include in the denial letter.
Office of Compliance Responsibilities
• The Office of Manufacturing Quality (OMQ) will:
‒ Provide input on the classification status of the facility when requested by OPMA.
PROCEDURES
Original ANDAs and OGD-Managed ANDA PASs
1. The ORO regulatory project manager (RPM) receives and reviews the amendment
submission cover letter for the facility-only major-to-minor reclassification request.
2. The ORO RPM determines whether to accept or not accept the reclassification request
for review. The ORO RPM accepts the request for review if all the criteria in bulleted
items a) through f) are met:
a) The reclassification request is submitted with a CR letter response amendment in a
single submission.
b) The reclassification request is submitted with the VAI or the NAI CGMP
classification letter issued by FDA to the facility, or a statement is provided
indicating that the facility is being withdrawn and did not manufacture batches or
conduct analyses intended to support approval of the application.
c) The reclassification request is easily identified by inclusion of the words “Facility-
Only Reclassification Request” in the cover letter for the amendment submitted in
response to the CR letter.
d) The reclassification request is specific to a facility deficiency, and that specific
deficiency is the only basis for the CR letter’s major classification. (Amendment
may contain other minor deficiencies, except as noted below for a CR letter that is
more than 1 year old and does not meet other criteria for acceptance.)
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e) The CR letter was issued on or after October 1, 2022 (the implementation date of
GDUFA III). 14
f) The CR letter is less than 1 year old at the time the request for reclassification is
submitted (from the date the CR letter was signed), or it is more than 1 year old
and one of the following applies:
1) The product is the subject of a response to a public health emergency as
declared by the Secretary of the U.S. Department of Health and Human
Services under section 319 of the Public Health Service Act (42 U.S.C. 247d).
2) The product is on the drug shortage list under section 506E of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 356e).
3) The facility deficiency is the only deficiency in the CR letter (i.e., the facility
issue is the only major deficiency (i.e., single), and there are no minor
deficiencies).
3. The ORO RPM triages the CR letter amendment that includes the reclassification
request.
4. The ORO RPM notifies the applicant via a formal correspondence indicating whether
its reclassification request is accepted for review and provides a decisional date
indicating when the reclassification request decision will be made.
5. The ORO RPM notifies OPRO of the facility-only deficiency major-to-minor
reclassification request and the decisional period (based on the priority or standard
designation) 15 by assigning it to OPRO.
6. OPRO assigns the reclassification request to the RBPM. Then, the RBPM assigns the
reclassification request to an OPMA assessor(s) for review.
7. The assigned OPMA assessor evaluates the reclassification request by determining
whether the facility deficiency, including any deficiency pertaining to the specific
application, is resolved (including the impact of a facility withdrawal, if applicable).
a) If the deficiency is resolved, the assessor determines whether a PAI or the use of
alternative tools is required to complete the assessment of the facility. If further
assessment via an inspection or the use of alternative tools is not necessary in
support of the application, the request will be granted.
14
See footnote 2.
15
See MAPP 5240.3 Rev. 6 Prioritization of the Review of Original ANDAs, Amendments, and Supplements
(available at https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-manual-policies-
procedures-mapp).
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b) If the deficiency remains unresolved or if a PAI or the use of alternative tools is
necessary to address the current concerns, the request will be denied. If the most
recent facility inspection designation was VAI, but FDA is continuing to evaluate
the facility’s remediation of prior OAI deficiencies, OPMA consults with the
assigned OMQ compliance officer. Within the agreed-upon timeline, OMQ
provides this information to OPMA. (Note: This step does not apply to withdrawn
facilities.)
c) If the facility or facilities that are the subject of the major deficiency are being
withdrawn and were listed on Form FDA 356h 16 and did not generate data to
support the primary basis for approval, the request will be granted (e.g.,
withdrawal of an alternate facility).
d) If the facility or facilities that are the subject of the major deficiency are being
withdrawn and generated data to support a regulatory action, data from those
facilities can no longer serve as the primary basis of approval. In this case, the
OPMA assessor evaluates the impact of the withdrawal or withdrawals on the
completeness of the application. This assessment will require significant time and
resources; consequently, the request should be denied.
8. The OPMA assessor communicates to the OPRO RBPM the decision regarding
whether to grant or deny the request. If the decision is to grant the request, the OPMA
assessor will reach out to OMQ, as needed, for input on the final classification
decision. Regardless of the outcome, the OPMA assessor documents the decision and
rationale in a memo and uploads the memo to the archival database.
9. OPRO informs the ORO RPM of the decision.
10. The ORO RPM drafts and issues to the applicant the decisional letter that includes the
applicable GDUFA goal date of the ANDA amendment(s) 17 as stated in the GDUFA
III commitment letter. See tables 1 and 2 in the Attachment, Generic Drug User Fee
Amendments Submission Types and Goal Dates.
16
See Form FDA 356h, available at https://www.fda.gov/media/72649/download.
17
The Office of Regulatory Operations regulatory project manager reviews and processes solicited and
unsolicited ANDA or drug master file amendments independently from the facility-based major-to-minor
reclassification request, including those that are received during the reclassification decisional period. In
addition, the Office of Regulatory Operations regulatory project manager reviews and classifies any content
deemed as major within the complete response letter response containing the facility-based reclassification
request independently from the facility-based reclassification request. If any such amendment or major content
affects the GDUFA goal date, the Office of Regulatory Operations regulatory project manager issues an
acknowledgment letter after issuing the facility-based reclassification grant or deny letter.
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OPQ-Managed ANDA PASs
1. OPRO receives the facility-only major-to-minor reclassification request and assigns it
to the RBPM.
2. The OPRO RBPM reviews the cover letter and determines whether to accept or not
accept the reclassification request for review. The OPRO RBPM accepts the
reclassification request for review if all the criteria in bulleted items a) through f) are
met:
a) The reclassification request is submitted with a CR letter response amendment in a
single submission.
b) The reclassification request is submitted with the VAI or the NAI CGMP
classification letter issued by FDA to the facility, or a statement is provided
indicating that the facility is being withdrawn and did not manufacture batches or
conduct analyses intended to support approval of the application.
c) The reclassification request is easily identified by inclusion of the words “Facility-
Only Reclassification Request” in the cover letter for the amendment submitted in
response to the CR letter.
d) The reclassification request is specific to a facility deficiency, and that specific
deficiency is the only basis for the CR letter’s major classification. (Amendment
may contain other minor deficiencies, except as noted below for a CR letter that is
more than 1 year old and does not meet other criteria for acceptance.)
e) The CR letter was issued on or after October 1, 2022 (the implementation date of
GDUFA III). 18
f) The CR letter is less than 1 year old at the time the request for reclassification is
submitted (from the date the CR letter was signed), or it is more than 1 year old
and one of the following applies:
1) The product is the subject of a response to a public health emergency as
declared by the Secretary of the U.S. Department of Health and Human
Services under section 319 of the Public Health Service Act or is anticipated to
be subject to the same criteria as applied to such a declaration at the time of
submission.
2) The product is on the drug shortage list under section 506E of the Federal
Food, Drug, and Cosmetic Act.
18
See footnote 2.
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3) The facility deficiency is the only deficiency in the CR letter (i.e., the facility
issue is the only major deficiency (i.e., single), and there are no minor
deficiencies).
3. The OPRO RBPM triages the CR letter amendment that includes the reclassification
request and assigns it to OPMA.
4. After a priority or standard designation has been made, the OPRO RBPM
communicates the decisional period to the OPQ assessment team.
5. The OPRO RBPM notifies the applicant via a formal correspondence indicating
whether its reclassification request is accepted for review and provides a decisional
date indicating when the reclassification request will be made.
6. The assigned OPMA assessor evaluates the reclassification request and makes a grant
or deny decision by determining whether the facility deficiency, including any
deficiency pertaining to the specific application, is resolved (including the impact of a
facility withdrawal, if applicable).
a) If the deficiency is resolved, the assessor determines whether a PAI or the use of
alternative tools is required to complete the assessment of the facility. If further
assessment via an inspection or the use of alternative tools is not necessary in
support of the application, the request will be granted.
b) If the deficiency remains unresolved or if a PAI or the use of alternative tools is
necessary to address the current concerns, the request will be denied. If the most
recent facility inspection designation was VAI, but FDA is continuing to evaluate
the facility’s remediation of prior OAI deficiencies, OPMA consults with the
assigned OMQ compliance officer. Within the agreed-upon timeline, OMQ
provides this information to OPMA. (Note: This step does not apply to withdrawn
facilities.)
c) If the facility or facilities that are the subject of the major deficiency are being
withdrawn and were listed on Form FDA 356h 19 and did not generate data to
support the primary basis for approval, the request will be granted (e.g.,
withdrawal of an alternate facility).
d) If the facility or facilities that are the subject of the major deficiency are being
withdrawn and generated data to support the change proposed in the supplement,
in such cases, because data from those facilities can no longer serve as the primary
basis of approval, the OPMA assessor evaluates the impact of the withdrawal or
withdrawals on the completeness of the supplemental application. This assessment
will require significant time and resources; consequently, the request should be
denied.
19
See footnote 16.
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7. The OPMA assessor communicates to the OPRO RBPM the decision regarding
whether to grant or deny the request and documents the decision and rationale in a
memo and uploads the memo to the archival database.
8. The OPRO RBPM drafts and issues to the applicant the decisional letter that includes
the applicable GDUFA goal date of the ANDA amendment(s) 20 as stated in the
GDUFA III commitment letter. See tables 1 and 2 in the Attachment, Generic Drug
User Fee Amendments Submission Types and Goal Dates.
EFFECTIVE DATE
• This MAPP is effective on January 15, 2024.
CHANGE CONTROL TABLE
Effective Date Revision Revisions
Number
6/27/2023 Initial N/A
1/15/2024 Rev. 1 Updated to include information that delineates how to assess
the impact of a facility withdrawal on the reclassification
request
20
The Office of Program and Regulatory Operations regulatory business process manager reviews and processes
solicited and unsolicited ANDA or drug master file amendments independently from the facility-based major-to-
minor reclassification request, including those that are received during the reclassification decisional period. In
addition, the Office of Program and Regulatory Operations regulatory business process manager reviews and
classifies any content deemed as major within the complete response letter response containing the facility-based
reclassification request independently from the facility-based reclassification request. If any such amendment or
major content affects the GDUFA goal date, the Office of Program and Regulatory Operations regulatory
business process manager issues an acknowledgment letter after issuing the facility-based reclassification grant
or deny letter.
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ATTACHMENT: Generic Drug User Fee Amendments Submission Types and Goal
Dates
As described in the GDUFA III commitment letter, 1 the goal dates for decisions on requests
for reclassification and for amendment assessments for which a request for reclassification is
submitted are as follows:
Table 1. Goal Dates for Reclassification Requests (Original ANDAs*)
Submission Type FDA Response New ANDA Goal Date ANDA Goal Date if
Regarding Major-to- if Reclassification Reclassification
Minor Reclassification Granted Denied**
Requests
Standard major Within 60 days of Within 5 months of Within 8 months of
amendment submission date submission date submission date if a
PAI* is not required
Within 10 months of
submission date if a PAI
is required
Priority major Within 30 days of Within 4 months of Within 6 months of
amendment submission date submission date submission date if a PAI
is not required
Within 8 months of
submission date if a PAI
is required and applicant
meets the requirements
under section
I(A)(5)(b)*** (i.e.,
adequate presubmission
facility correspondence)
Within 10 months of
submission date if a PAI
is required and applicant
meets any limitations as
described under section
I(A)(6)*** (i.e.,
presubmission facility
correspondence not
adequate)
* ANDA = abbreviated new drug application; PAI = preapproval inspection.
** Goal date for PASs will be different. See table 2 below.
*** See the GDUFA III commitment letter.
1
See the GDUFA III commitment letter titled “Reauthorization Performance Goals and Program Enhancements
Fiscal Years 2023-2027” available on the FDA website at https://www.fda.gov/media/153631/download.
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Table 2. Goal Dates for Reclassification Requests (PASs*)
Submission Type FDA Response New PAS Goal Date if PAS Goal Date if
Regarding Major-to- Reclassification Reclassification
Minor Reclassification Granted Denied**
Requests
Standard major Within 60 days of Within 5 months of Within 6 months of
amendment submission date submission date if no submission date if a
inspection is required PAI* is not required
Within 10 months of
submission date if a PAI
is required
Priority major Within 30 days of Within 4 months of Within 4 months of
amendment submission date submission date if no submission date if a PAI
inspection is required is not required
Within 8 months of
submission date if a PAI
is required and applicant
meets the requirements
under section
I(B)(4)(b)*** (i.e.,
adequate presubmission
facility correspondence)
Within 10 months of
submission date if a PAI
is required and applicant
meets the requirement
under section
I(B)(4)(c)*** (i.e.,
presubmission facility
correspondence not
adequate)
* PAS = prior approval supplement; PAI = preapproval inspection.
** Goal date for ANDAs will be different. See table 1 above.
*** See the GDUFA III commitment letter.
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来源：FDA Pharmaceutical Quality Documents · fda.gov