Notice2026-04252
E2D(R1) Postapproval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports; International Council for Harmonisation; Guidance for Industry; Availability
Primary source
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Published
March 4, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "E2D(R1) Postapproval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports." The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance updates the 2003 guidance titled "E2D Post- Approval Safety Data Management: Definitions and Standards for Expedited Reporting," by clarifying the use of new or increasingly used data sources (e.g., social media, market research programs, patient support programs). This final guidance clarifies the use of new postapproval safety sources and update terminology and standards for postapproval adverse event reporting. The guidance replaces the draft guidance "E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports" issued on March 14, 2024, and the final guidance issued September 15, 2003.
Full Text
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<title>Federal Register, Volume 91 Issue 42 (Wednesday, March 4, 2026)</title>
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[Federal Register Volume 91, Number 42 (Wednesday, March 4, 2026)]
[Notices]
[Pages 10619-10621]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-04252]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-D-0803]
E2D(R1) Postapproval Safety Data: Definitions and Standards for
Management and Reporting of Individual Case Safety Reports;
International Council for Harmonisation; 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 final guidance for industry entitled ``E2D(R1)
Postapproval Safety Data: Definitions and Standards for Management and
Reporting of Individual Case Safety Reports.'' The guidance was
prepared under the auspices of the International Council for
Harmonisation of Technical Requirements for Pharmaceuticals for Human
Use (ICH). The guidance updates the 2003 guidance titled ``E2D Post-
Approval Safety Data Management: Definitions and Standards for
Expedited Reporting,'' by clarifying the use of new or increasingly
used data sources (e.g., social media, market research programs,
patient support programs). This final guidance clarifies the use of new
postapproval safety sources and update terminology and standards for
postapproval adverse event reporting. The guidance replaces the draft
guidance ``E2D(R1) Post-Approval Safety Data: Definitions and Standards
for Management and Reporting of Individual Case Safety Reports'' issued
on March 14, 2024, and the final guidance issued September 15, 2003.
DATES: The announcement of the guidance is published in the Federal
Register on March 4, 2026.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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
[[Page 10620]]
manner detailed (see ``Written/Paper Submissions'' and
``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> 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.
<bullet> 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-2024-D-0803 for ``E2D(R1) Postapproval Safety Data: Definitions and
Standards for Management and Reporting of Individual Case Safety
Reports.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper 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 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 this 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 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 or emailing
<a href="/cdn-cgi/l/email-protection#6801060c1d1b1c1a11460a010704070f010b1b280e0c094600001b460f071e"><span class="__cf_email__" data-cfemail="f59c9b91808681878cdb979c9a999a929c9686b5939194db9d9d86db929a83">[email protected]</span></a>. See the SUPPLEMENTARY INFORMATION
section for electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Robert Ball, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
22, Rm. 4300, Silver Spring, MD 20993-0002, <a href="/cdn-cgi/l/email-protection#e6a9b5a3c8b6abadb2b4a3a1b5a6808287c88e8e95c8818990"><span class="__cf_email__" data-cfemail="4708140269170a0c131502001407212326692f2f3469202831">[email protected]</span></a>;
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,
<a href="/cdn-cgi/l/email-protection#adefdfc2c2c6c883e9ccc1feccc3d9c2edcbc9cc83c5c5de83cac2db"><span class="__cf_email__" data-cfemail="ce8cbca1a1a5abe08aafa29dafa0baa18ea8aaafe0a6a6bde0a9a1b8">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``E2D(R1) Postapproval Safety Data: Definitions and Standards
for Management and Reporting of Individual Case Safety Reports.'' The
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 <a href="https://www.ich.org/">https://www.ich.org/</a>).
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 the Federal Register of March 14, 2024, (89 FR 18644), FDA
published a notice announcing the availability of a draft guidance
entitled ``E2D(R1) Post-Approval Safety Data: Definitions and Standards
for Management and Reporting of Individual Case Safety Reports.'' The
notice gave interested persons an opportunity to submit comments by May
13, 2024.
After consideration of the comments received and revisions to the
guideline, a final draft of the guideline was submitted to the ICH
Assembly and endorsed by the regulatory agencies in September 2025.
This guidance finalizes the draft guidance issued on March 14,
2024. The guidance provides updated internationally standardized
procedures for gathering and reporting safety data. Approximately 450
comments were
[[Page 10621]]
received during public consultation. Numerous revisions were made to
address public comments and provide greater clarity to key topics. The
final guidance includes a new section on noninterventional studies.
This section provides guidance on handling adverse event information
arising from primary data collection versus the secondary use of data.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``E2D(R1) Postapproval Safety Data:
Definitions and Standards for Management and Reporting of Individual
Case Safety Reports.'' 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. FDA considered the applicability of Executive Order
14192, per Office of Management and Budget (OMB) guidance in M-25-20,
and finds this action to be deregulatory in nature.
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
pertaining to postmarketing adverse drug experience reporting have been
approved under OMB control number 0910-0230. The collection of
information for FDA adverse event reporting and electronic submissions
using the Electronic Submission Gateway and the Safety Reporting Portal
has been approved under OMB control number 0910-0291. The collections
of information pertaining to the issuance of ``Dear Health Care
Provider'' letters: improving communication of important safety
information have been approved under OMB control number 0910-0754.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
<a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>,
<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a> or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-04252 Filed 3-3-26; 8:45 am]
BILLING CODE 4164-01-P
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