[Federal Register Volume 91, Number 13 (Wednesday, January 21, 2026)]
[Notices]
[Pages 2539-2540]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-01073]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-D-2275]
M4Q(R2) The Common Technical Document for the Registration of
Pharmaceuticals for Human Use: Quality; International Council for
Harmonisation; Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a draft guidance for industry entitled
``M4Q(R2) The Common Technical Document for the Registration of
Pharmaceuticals for Human Use: Quality.'' The draft guidance was
prepared under the auspices of the International Council for
Harmonisation of Technical Requirements for Pharmaceuticals for Human
Use (ICH). The draft guidance is intended to establish a globally
harmonized framework to organizing and presenting quality data included
in registration applications for medicinal products for human use. The
draft guidance updates the quality section of the common technical
document (CTD) to further improve registration and life cycle
management efficiency, facilitate digitalization and knowledge
management, and support provisions for emerging technologies.
DATES: Submit either electronic or written comments on the draft
guidance by March 23, 2026 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2025-D-2275 for ``M4Q(R2) The Common Technical Document for the
Registration of Pharmaceuticals for Human Use: Quality.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, 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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive
[[Page 2540]]
label to assist that office in processing your requests. The guidance
may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-
402-8010. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Lawrence Yu, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 4178, Silver Spring, MD 20993-0002, [email protected]; or
Phillip Kurs, Center for Biologics Evaluation and Research, Food and
Drug Administration, 240-402-7911.
Regarding the ICH: Brooke Dal Santo, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6304, Silver Spring, MD 20993-0002, 301-348-1967,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``M4Q(R2) The Common Technical Document for the Registration
of Pharmaceuticals for Human Use: Quality.'' The draft guidance was
prepared under the auspices of ICH. ICH seeks to achieve greater
regulatory harmonization worldwide to ensure that safe, effective,
high-quality medicines are developed, registered, and maintained in the
most resource-efficient manner.
By harmonizing the regulatory requirements in regions around the
world, ICH guidelines enhance global drug development, improve
manufacturing standards, and increase the availability of medications.
For example, ICH guidelines have substantially reduced duplicative
clinical studies, prevented unnecessary animal studies, standardized
the reporting of important safety information, and standardized
marketing application submissions.
The six Founding Members of the ICH are the FDA; the Pharmaceutical
Research and Manufacturers of America; the European Commission; the
European Federation of Pharmaceutical Industries Associations; the
Japanese Ministry of Health, Labour, and Welfare; and the Japanese
Pharmaceutical Manufacturers Association. The Standing Members of the
ICH Association include Health Canada and Swissmedic. ICH membership
continues to expand to include other regulatory authorities and
industry associations from around the world (refer to https://www.ich.org/).
ICH works by engaging global regulatory and industry experts in a
detailed, science-based, and consensus-driven process that results in
the development of ICH guidelines. The regulators around the world are
committed to consistently adopting these consensus-based guidelines,
realizing the benefits for patients and for industry.
As a Founding Regulatory Member of ICH, FDA plays a major role in
the development of each of the ICH guidelines, which FDA then adopts
and issues as guidance for industry. FDA's guidance documents do not
establish legally enforceable responsibilities. Instead, they describe
the Agency's current thinking on a topic and should be viewed only as
recommendations, unless specific regulatory or statutory requirements
are cited.
In May 2025, the ICH Assembly endorsed the draft guideline entitled
``M4Q(R2) The Common Technical Document for the Registration of
Pharmaceuticals for Human Use: Quality'' and agreed that the guideline
should be made available for public comment. The draft guideline is the
product of the Multidisciplinary Expert Working Group of the ICH.
Comments about this draft will be considered by FDA and the
Multidisciplinary Expert Working Group.
The draft guidance provides guidance on structure and location of
quality information for the CTD. It provides a flexible framework to
accommodate different types of products and submissions while
organizing information in a granular, globally consistent format to
facilitate digitalization and knowledge management.
This draft guidance has been left in the original ICH format. The
final guidance will be reformatted and edited to conform with FDA's
good guidance practices regulation (21 CFR 10.115) and style before
publication. The draft guidance, when finalized, will represent the
current thinking of FDA on ``M4Q(R2) The Common Technical Document for
the Registration of Pharmaceuticals for Human Use: Quality.'' It does
not establish any rights for any person and is not binding on FDA or
the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.
As we develop final guidance on this topic, FDA will consider
comments on costs or cost savings the guidance may generate, relevant
for Executive Order 14192.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
OMB under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521). The collections of information in 21 CFR part 314 for submission
of new drug applications and abbreviated new drug applications and
master files have been approved under OMB control 0910-0001. The
collections of information in 21 CFR 312 for content and format have
been approved under OMB control number 0910-0014. The collections of
information for the submission of biological license applications under
21 CFR part 601 have been approved under OMB control number 0910-0338.
The collections of information for the submission and review of
biosimilar product applications and related biosimilar requirements
have been approved under OMB control number 0910-0718. The collections
of information for current good manufacturing practice in the
manufacture, processing, packing and storage of finished
pharmaceuticals in 21 CFR parts 210 and 211 have been approved under
OMB control number 0910-0139. The collections of information in 21 CFR
part 201 for labeling of prescription drug and biological products have
been approved under OMB control number 0910-0572.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at https://www.regulations.gov, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.fda.gov/regulatory-information/search-fda-guidance-documents.
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2026-01073 Filed 1-20-26; 8:45 am]
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