Rule2026-03286
Revocation of Regulations Regarding the Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and the European Community
Primary source
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Published
February 19, 2026
Effective
March 23, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule revoking the regulations entitled "Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community." FDA is taking this action because the regulations at 21 CFR part 26 have been superseded in part by the "United States-European Union Amended Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMPs)" that entered into force in 2017 (2017 Amended Pharmaceutical Annex), are outdated, do not reflect current Agency practice, and are unnecessary.
Full Text
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<title>Federal Register, Volume 91 Issue 33 (Thursday, February 19, 2026)</title>
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[Federal Register Volume 91, Number 33 (Thursday, February 19, 2026)]
[Rules and Regulations]
[Pages 7825-7829]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-03286]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 26
[Docket No. FDA-2024-N-4016]
RIN 0910-AI92
Revocation of Regulations Regarding the Mutual Recognition of
Pharmaceutical Good Manufacturing Practice Reports, Medical Device
Quality System Audit Reports, and Certain Medical Device Product
Evaluation Reports: United States and the European Community
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
issuing a final rule revoking the regulations entitled ``Mutual
Recognition of Pharmaceutical Good Manufacturing Practice Reports,
Medical Device Quality System Audit Reports, and Certain Medical Device
Product Evaluation Reports: United States and The European Community.''
FDA is taking this action because the
[[Page 7826]]
regulations at 21 CFR part 26 have been superseded in part by the
``United States-European Union Amended Sectoral Annex for
Pharmaceutical Good Manufacturing Practices (GMPs)'' that entered into
force in 2017 (2017 Amended Pharmaceutical Annex), are outdated, do not
reflect current Agency practice, and are unnecessary.
DATES: This rule is effective March 23, 2026.
ADDRESSES: For access to the docket to read background documents or
comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the
docket number found in brackets in the heading of this final rule into
the ``Search'' box and follow the prompts, and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
240-402-7500.
FOR FURTHER INFORMATION CONTACT: Megan Andersen, Office of Inspections
and Investigations, Food and Drug Administration, 10903 New Hampshire
Avenue, Silver Spring, MD 20993, 202-684-5901,
<a href="/cdn-cgi/l/email-protection#bcd1d9dbddd292ddd2d8d9cecfd9d2fcdad8dd92d4d4cf92dbd3ca"><span class="__cf_email__" data-cfemail="b8d5dddfd9d696d9d6dcddcacbddd6f8dedcd996d0d0cb96dfd7ce">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose of the Final Rule
B. Summary of the Major Provisions of the Final Rule
C. Legal Authority
D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
A. Need for the Regulation/History of This Rulemaking
B. Summary of Comments to the Proposed Rule
IV. Legal Authority
V. Comments on the Proposed Rule and FDA Response
A. Introduction
B. Description of General Comments and FDA Response
C. Specific Comments and FDA Response
VI. Effective Date/Compliance Date(s)
VII. Economic Analysis of Impacts
A. Introduction
B. Overview of Benefits, Costs, and Transfers
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With Indian Tribal Governments
XII. References
I. Executive Summary
A. Purpose of the Final Rule
FDA is revoking the regulations at part 26 (21 CFR part 26), which
substantially reflect certain provisions of the ``Agreement on Mutual
Recognition Between the United States of America and the European
Community'' that was signed in 1998 (1998 MRA). These regulations have
been superseded in part by the 2017 Amended Pharmaceutical Annex, are
outdated, do not reflect current Agency practice, and are unnecessary.
B. Summary of the Major Provisions of the Final Rule
The final rule revokes part 26, ``Mutual Recognition of
Pharmaceutical Good Manufacturing Practice Reports, Medical Device
Quality System Audit Reports, and Certain Medical Device Product
Evaluation Reports: United States and The European Community.'' This
part substantially reflects certain provisions of the 1998 MRA between
the United States and the European Community (EC) that were created to
better utilize the inspectional resources of each signatory by
recognizing one another's inspection reports. Part 26 consists of 3
subparts: Subpart A--Specific Sector Provisions for Pharmaceutical Good
Manufacturing Practices (which substantially reflects the 1998 MRA's
``pharmaceutical sectoral annex''), Subpart B--Specific Sector
Provisions for Medical Devices (which substantially reflects the 1998
MRA's ``medical device sectoral annex''), and Subpart C--``Framework''
Provisions (which substantially reflects the 1998 MRA's ``umbrella''
agreement that contained general provisions applicable to the operation
of all of the sectoral annexes).
C. Legal Authority
FDA is taking this action under the general administrative
provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (see
generally 21 U.S.C. 301-399). We discuss our legal authority in greater
detail in part IV.
D. Costs and Benefits
Because this final rule would not impose any additional regulatory
burdens, this regulation is not anticipated to result in any compliance
costs and the economic impact, if any, is expected to be minimal.
II. Table of Abbreviations/Commonly Used Acronyms in This Document
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Abbreviation What it means
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EC........................................ European Community.
EU........................................ European Union.
FD&C Act.................................. Federal Food, Drug, and
Cosmetic Act.
GMP....................................... Good Manufacturing Practice.
MRA....................................... Mutual Recognition
Agreement.
------------------------------------------------------------------------
III. Background
A. Need for the Regulation/History of This Rulemaking
Part 26 was issued in response to the 1998 MRA between the United
States and the EC, under which both parties would recognize certain
drug and device inspection/evaluation reports of the other, in order to
more effectively allocate limited inspection resources (Mutual
Recognition of Pharmaceutical Good Manufacturing Practice Inspection
Reports, Medical Device Quality System Audit Reports, and Certain
Medical Device Product Evaluation Reports Between the United States and
the European Community, 63 FR 60122 at 60141 (November 6, 1998)).
Subparts A and B of part 26 substantially reflect the 1998 MRA's
pharmaceutical and medical device sectoral annexes, respectively.
Subpart C of part 26 sets forth the framework provisions by which
Subparts A and B can be implemented. Subpart A governs ``the exchange
between the parties and normal endorsement by the receiving regulatory
authority of official [pharmaceutical] good manufacturing practices
(GMP) inspection reports[.]'' (21 CFR 26.2). Subpart B specifies ``the
conditions under which a party will accept the results of quality
system-related evaluations and inspections and premarket evaluations of
the other party with regard to medical devices as conducted by listed
conformity assessment bodies (CAB's)'' and provides for ``other related
cooperative activities.'' (21 CFR 26.31(a)).
The pharmaceutical sectoral annex to the 1998 MRA was superseded by
the 2017 Amended Pharmaceutical Annex (<a href="https://www.fda.gov/international-programs/international-arrangements/mutual-recognition-agreements-mra">https://www.fda.gov/international-programs/international-arrangements/mutual-recognition-agreements-mra</a>). The 2017 Amended Pharmaceutical Annex included new
terms, rendering Subpart A obsolete. The medical device sectoral annex
was not addressed in the 2017 Amended Pharmaceutical Annex, but since
the 1998 MRA went into effect, it has never been fully implemented. As
other mechanisms (e.g., Medical Device Single Audit Program) now exist
for mutual recognition with Europe with respect to medical device
inspections, Subpart B is no longer necessary. Subpart C contains
general provisions applicable to both Subparts A and B that will be
unnecessary once Subparts A and B are revoked.
FDA published a notice of proposed rulemaking that would revoke 21
CFR part 26 in the Federal Register on September 20, 2024 (89 FR
77062). The public was invited to submit electronic
[[Page 7827]]
or written comments during the comment period, which closed on November
19, 2024.
B. Summary of Comments to the Proposed Rule
FDA received eight submissions on the proposed rule by the close of
the 60-day comment period with each containing one or more comments on
one or more issues. Some of the comments were submitted by individuals
and some were submitted anonymously. Some of the comments supported the
proposed rule while others were opposed to the proposed rule.
IV. Legal Authority
We are issuing this final rule under the drugs, medical devices,
and general administrative provisions of the FD&C Act (21 U.S.C. 321,
331, 351, 352, 355, 360, 360b, 360c, 360d, 360e, 360f, 360g, 360h,
360i, 360j, 360l, 360m, 371, 374, 381, 382, 383, 384e, and 393) and
under certain provisions of the Public Health Service Act (42 U.S.C.
216, 241, 242l, 262, 264, and 265). Under section 701(a) of the FD&C
Act (21 U.S.C. 371(a)), FDA has the authority to issue regulations, and
under section 809 of the FD&C Act (21 U.S.C. 384e), FDA has the
authority to ``enter into arrangements and agreements with a foreign
government or an agency of a foreign government to recognize the
inspection of foreign establishments registered under section 510(i) in
order to facilitate preapproval or risk-based inspections in accordance
with the schedule established in paragraph (2) or (3) of section
510(h)[.]''
V. Comments on the Proposed Rule and FDA Response
A. Introduction
We received eight comment submissions on the proposed rule by the
close of comment period, with each containing one or more comments on
one or more issues. Some of the comments were submitted by individuals
while others were submitted anonymously.
We describe and respond to the comments in section V.B. and V.C. of
this document. We have numbered each comment to help distinguish
between different comments. We have grouped similar comments together
under the same number, and in some cases, we have separated different
issues discussed in the same comment and designated them as distinct
comments for purposes of our responses. The number assigned to each
comment or comment topic is purely for organizational purposes and does
not signify the comment's value or importance or the order in which
comments were received.
We also received several comments that were not responsive to the
content of the proposed rule, and therefore, were not considered in its
final development. After reviewing and considering all comments that
were responsive to the proposed rule, we are finalizing the proposed
rule without change.
B. Description of General Comments and FDA Response
Several comments make general remarks either supporting or opposing
the proposed rule. In the following paragraphs, we discuss and respond
to such general comments.
(Comment 1) Three comments are in support of finalizing the
proposed rule and recommend FDA provide clear guidance about the
changes and their impact to help maintain compliance and uphold high
safety and quality standards.
(Response 1) We agree with the comments and in the proposed rule we
stated that the rule would not impose any new changes or additional
regulatory burdens. The rule is not anticipated to result in any
compliance costs and the economic impact, if any, is expected to be
minimal.
C. Specific Comments and FDA Response
(Comment 2) One comment asks how an MRA has the force of law such
that it could supersede a regulation for which the American public
received advanced notice and opportunity to comment.
(Response 2) MRAs are agreements between two or more countries or
regulatory counterparts to recognize certain processes or procedures.
In the context of FDA, MRAs have generally focused on recognizing the
inspections and accepting the inspectional documents of foreign
regulatory authorities. FDA's current MRAs, including the 2017 Amended
Pharmaceutical Annex, are binding international agreements entered into
by the United States. (22 CFR 181.2) In 2012, the 112th Congress
passed, and the President signed into law, Title VII of the Food and
Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-
144) amending the FD&C Act. Under the FD&C Act as amended, FDA itself
has the authority to enter into agreements to recognize inspections
conducted by foreign regulatory authorities if FDA determines those
authorities are capable of conducting inspections that meet the
applicable requirements of the FD&C Act.
When the United States entered into an MRA with the EC in 1998, FDA
issued part 26, which substantially reflects certain provisions of the
1998 MRA. Under 21 CFR 26.80(b), the 1998 MRA can be ``amended in
writing by the parties to that agreement.'' In 2017, the 1998 MRA was
amended through an exchange of letters between the United States and
the European Union (EU).
The regulations at part 26 also provide that ``[i]f the parties to
the MRA subsequently amend or terminate the MRA, FDA will modify this
part accordingly, using appropriate administrative procedures[.]'' (21
CFR 26.0). We have determined that this rulemaking is an appropriate
procedure for revoking the regulations at part 26.
As we explained in the proposed rule, we do not believe it is
required or would be beneficial for FDA to issue regulations that
substantially reflect the 2017 Amended Pharmaceutical Annex with the
EU. The 2017 Amended Pharmaceutical Annex is in force and has been
successfully implemented without regulations that substantially reflect
it. The same is true for the MRAs that the United States entered into
subsequently with Switzerland and the United Kingdom (<a href="https://www.fda.gov/international-programs/international-arrangements/mutual-recognition-agreements-mra">https://www.fda.gov/international-programs/international-arrangements/mutual-recognition-agreements-mra</a>).
(Comment 3) One comment asserts that revoking the MRA on
pharmaceutical inspections would lead to increased costs, reduced
access to affordable medications, and potentially less international
collaboration.
(Response 3) This rule does not revoke an MRA. This rule revokes
the regulations that substantially reflect certain provisions of the
1998 MRA. As noted, in 2017, the United States and the EU completed an
exchange of letters to amend the 1998 MRA. Under the 2017 Amended
Pharmaceutical Annex, which is in force and has been successfully
implemented, United States and EU regulators are able to utilize each
other's GMP inspections of pharmaceutical manufacturing facilities.
FDA's revocation of part 26 should not be interpreted as FDA retreating
from our commitment to working with our foreign counterparts, including
through MRAs, to achieve greater efficiencies and increase our
inspectional reach.
VI. Effective Date/Compliance Date(s)
This final rule is effective 30 days after publication in the
Federal Register.
[[Page 7828]]
VII. Economic Analysis of Impacts
A. Introduction
We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, Executive Order 14192, the
Regulatory Flexibility Act (5 U.S.C. 601-612), the Congressional Review
Act/Small Business Regulatory Enforcement Fairness Act (5 U.S.C. 801,
Pub. L. 104-121), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4).
Executive Orders 12866 and 13563 direct us to assess all benefits
and costs of available regulatory alternatives and, when regulation is
necessary, to select regulatory approaches that maximize net benefits.
Rules are ``significant'' under Executive Order 12866 if they have an
annual effect on the economy of $100 million or more; or adversely
affect in a material way the economy, a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or State, local, or tribal governments or communities. The
Office of Information and Regulatory Affairs (OIRA) has determined that
this final rule is not a significant regulatory action under Executive
Order 12866.
Executive Order 14192 requires that any new incremental costs
associated with certain significant regulatory actions ``shall, to the
extent permitted by law, be offset by the elimination of existing costs
associated with at least 10 prior regulations.'' This final rule is
considered an Executive Order 14192 deregulatory action.
Because this rule is not likely to result in an annual effect on
the economy of $100 million or more or meets other criteria specified
in the Congressional Review Act/Small Business Regulatory Enforcement
Fairness Act, OIRA has determined that this rule does not fall within
the scope of 5 U.S.C. 804(2).
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because this final rule does not add any new regulatory
burden on the pharmaceutical or medical device industries, we certify
that the final rule will not have a significant economic impact on a
substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes estimates of
anticipated impacts, before issuing ``any rule that includes any
Federal mandate that may result in the expenditure by State, local, and
tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $187
million, using the most current (2024) Implicit Price Deflator for the
Gross Domestic Product. This final rule will not result in an
expenditure in any year that meets or exceeds this amount.
B. Overview of Benefits, Costs, and Transfers
We believe industry will maintain its current practices following
the removal of part 26. In line with Executive Order 14192, in Table 1
we estimate present and annualized values of costs, cost savings, and
net costs over a perpetual time horizon. We estimate that this rule
will generate no quantifiable costs or cost savings. Therefore, we
expect this final rule to be cost neutral.
Table 1--Summary of Benefits, Costs, and Distributional Effects of Final Rule
[Millions of 2024 dollars]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Units
------------------------------------
Category Primary Low High Period Notes
estimate estimate estimate Year Discount covered
dollars rate (%) (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
Annualized Monetized $millions/year...... $0 $0 $0 2024 7 10
0 0 0 2024 3 10
Annualized Quantified.................... .......... .......... .......... .......... .......... ..........
.......... .......... .......... .......... .......... ..........
----------------------------------------------------------------------------------------------------------
Qualitative.............................. Avoid confusion created by .......... .......... ..........
outdated and unnecessary
regulations that do not reflect
current Agency practice.
----------------------------------------------------------------------------------------------------------
Costs:
Annualized Monetized $millions/year...... 0 0 0 2024 7 10
0 0 0 2024 3 10
Annualized Quantified.................... .......... .......... .......... .......... 7 ..........
.......... .......... .......... .......... 3 ..........
Qualitative.............................. .......... .......... .......... .......... .......... ..........
Transfers:
Federal Annualized Monetized $millions/ .......... .......... .......... .......... 7 ..........
year. .......... .......... .......... .......... 3 ..........
----------------------------------------------------------------------------------------------------------
From/To.................................. From:
To:
----------------------------------------------------------------------------------------------------------
Other Annualized Monetized $millions/year .......... .......... .......... .......... 7 ..........
.......... .......... .......... .......... 3 ..........
----------------------------------------------------------------------------------------------------------
From/To.................................. From:
To:
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Effects:
State, Local or Tribal Government: No estimated effect..............................................................................................
Small Business: No estimated effect.................................................................................................................
Wages: No estimated effect..........................................................................................................................
Growth: No estimated effect.........................................................................................................................
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[[Page 7829]]
In line with Executive Order 14192, in Table 2 we estimate present
and annualized values of costs, cost savings, and net costs over a
perpetual time horizon. We estimate that this rule will generate $0 in
annualized net costs at a 7 percent discount rate, discounted relative
to year 2024, over a perpetual time horizon.
Table 2--Executive Order 14192 Summary Table
[Millions of 2024 dollars, discounted over a perpetual time horizon relative to year 2024 at a 7 percent
discount rate]
----------------------------------------------------------------------------------------------------------------
Primary (7%) Lower bound (7%) Upper bound (7%)
----------------------------------------------------------------------------------------------------------------
Present Value of Costs.............................. $0 $0 $0
Present Value of Cost Savings....................... 0 0 0
Present Value of Net Costs.......................... 0 0 0
Annualized Costs.................................... 0 0 0
Annualized Cost Savings............................. 0 0 0
Annualized Net Costs................................ 0 0 0
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VIII. Analysis of Environmental Impact
We have determined under 21 CFR 25.31(h) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
IX. Paperwork Reduction Act of 1995
This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
X. Federalism
We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. We have determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, we conclude that the rule
does not contain policies that have federalism implications as defined
in the Executive Order and, consequently, a federalism summary impact
statement is not required.
XI. Consultation and Coordination With Indian Tribal Governments
We have analyzed this rule in accordance with the principles set
forth in Executive Order 13175. We have determined that this final rule
does not contain policies that have substantial direct effects on one
or more Indian Tribes, on the relationship between the Federal
Government and Indian Tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian Tribes.
Accordingly, we conclude that the rule does not contain policies that
have tribal implications as defined in the Executive Order and,
consequently, a tribal summary impact statement is not required.
List of Subjects in 21 CFR Part 26
Animal, Animal drugs, Biologics, Drugs, Exports, Imports.
PART 26--[REMOVED]
0
Therefore, under the Federal Food, Drug, and Cosmetic Act, and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
26 is removed.
Robert F. Kennedy, Jr.,
Secretary, Department of Health and Human Services.
[FR Doc. 2026-03286 Filed 2-18-26; 8:45 am]
BILLING CODE 4164-01-P
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