[Federal Register Volume 90, Number 119 (Tuesday, June 24, 2025)]
[Notices]
[Pages 26820-26822]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-11552]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-D-1106]
Q1 Stability Testing of Drug Substances and Drug Products;
International Council for Harmonisation; Draft Guidance for Industry;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 or Agency) is announcing
the availability of a draft guidance for industry entitled ``Q1
Stability Testing of Drug Substances and Drug Products.'' The draft
guidance was prepared under the auspices of the International Council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 The draft guidance outlines stability data
expectations for drug substances and drug products to support drug
product marketing, including marketing authorization applications and,
where applicable, drug master files. This draft guidance is a
consolidated revision of the ICH Q1A(R2), Q1B, Q1C, Q1D, Q1E, and Q5C
series of stability guidances, published November 2003, March 1996, May
1997, January 2003, June 2004, and July 1996, respectively. The
revision also provides stability related guidance for product
categories such as advanced therapy medicinal products, vaccines, and
other complex biological products including combination products that
were not previously covered under the existing stability guidances. The
draft guidance is intended to provide an internationally harmonized
approach to conducting and presenting data on stability testing for
drug substances and drug products, as well as providing alternative,
scientifically justified approaches that may be encountered due to
scientific considerations and characteristics of the data being
evaluated.
DATES: Submit either electronic or written comments on the draft
guidance by August 25, 2025 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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
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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-1106 is for ``Q1 Stability Testing of Drug Substances and
Drug Products.'' 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, or the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. The guidance may also be obtained by mail by calling
Center for Biologics Evaluation and Research 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: Ee-Sunn Chia, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 21, Rm. 2550, Silver Spring, MD 20993-0002, 240-402-8909, email:
[email protected]; or Ramjay Vatsan Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 6010, 240-402-8364, email:
[email protected].
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:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Q1 Stability Testing of Drug Substances and Drug Products.''
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 April 2025, the ICH Assembly endorsed the draft guideline
entitled ``Q1 Stability Testing of Drug Substances and Drug Products''
and agreed that the guideline should be made available for public
comment. The draft guideline is the product of the Quality Expert
Working Group of the ICH. Comments about this draft will be
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considered by FDA and the Quality Expert Working Group.
The draft guidance provides recommendations on data expectations
for drug substances and drug products to support marketed drug products
including those with registration submissions, lifecycle/postapproval
changes, and when applicable, master files. This draft guidance
consolidates and updates the recommendations made in the ICH Q1A(R2),
Q1B, Q1C, Q1D, Q1E, and Q5C series of stability guidances (available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents), by addressing consistency of interpretation, clarification
of technical components of stability concepts, recommendations for new
technologies and tools used to facilitate an enhanced product
understanding, and applicability of recommendations across the
lifecycle of a product. This draft guidance can apply to all marketing
authorization applications of prescription and nonprescription drugs
(e.g., new, abbreviated) for a broad range of drug substances and
products (e.g., chemically synthesized, therapeutic and well-
characterized proteins and polypeptides, vaccines, cell and gene
therapy, drug-device combinations, natural health products).
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 ``Q1 Stability Testing of Drug Substances
and Drug Products'' and will supersede the ICH Q1A(R2), Q1B, Q1C, Q1D,
and Q1E guidances. 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
the Office of Management and Budget (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 have been approved under OMB control
number 0910-0001. 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 OTC monograph drug products have been approved under
OMB control number 0910-0340. The collections of information for the
submission and review of biosimilar product applications and related
biosimilar user fee requirements have been approved under OMB control
number 0910-0718. The collections of information for the submission and
review of correspondence for generic drug products and related generic
drug user fee requirements have been approved under OMB control number
0910-0727. 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.
Dated: June 18, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-11552 Filed 6-23-25; 8:45 am]
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