Notice2026-06660
Electronic Submission of Postmarketing Individual Case Safety Reports to the Food and Drug Administration Adverse Event Monitoring System Using International Council of Harmonisation E2B(R3) Data Standards; Regional Data Elements and Implementation Schedule
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Published
April 6, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is announcing an updated data standard requirement for the submission of postmarketing individual case safety report (ICSR) submissions for human drug products, biological products, and drug- or biologic-led combination products to the FDA Adverse Event Monitoring System (AEMS) database (formerly FDA Adverse Event Reporting System (FAERS)) via the Electronic Submissions Gateway Next Generation (ESG NextGen). Starting October 1, 2026, postmarketing ICSRs must be reported using the data standards adopted by FDA in the International Council for Harmonisation (ICH) guidance for industry entitled "E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide--Data Elements and Message Specification" (ICH E2B(R3) Implementation Guidance), which incorporates by reference regional implementation guides (collectively ICH E2B(R3) data standards).
Full Text
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<title>Federal Register, Volume 91 Issue 65 (Monday, April 6, 2026)</title>
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[Federal Register Volume 91, Number 65 (Monday, April 6, 2026)]
[Notices]
[Pages 17284-17285]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-06660]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-1280]
Electronic Submission of Postmarketing Individual Case Safety
Reports to the Food and Drug Administration Adverse Event Monitoring
System Using International Council of Harmonisation E2B(R3) Data
Standards; Regional Data Elements and Implementation Schedule
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing an
updated data standard requirement for the submission of postmarketing
individual case safety report (ICSR) submissions for human drug
products, biological products, and drug- or biologic-led combination
products to the FDA Adverse Event Monitoring System (AEMS) database
(formerly FDA Adverse Event Reporting System (FAERS)) via the
Electronic Submissions Gateway Next Generation (ESG NextGen). Starting
October 1, 2026, postmarketing ICSRs must be reported using the data
standards adopted by FDA in the International Council for Harmonisation
(ICH) guidance for industry entitled ``E2B(R3) Electronic Transmission
of Individual Case Safety Reports (ICSRs) Implementation Guide--Data
Elements and Message Specification'' (ICH E2B(R3) Implementation
Guidance), which incorporates by reference regional implementation
guides (collectively ICH E2B(R3) data standards).
DATES: For postmarketing ICSRs for human drug products, biological
products, and drug- or biologic-led combination products submitted via
ESG NextGen, beginning October 1, 2026, the ICSRs must be submitted to
the AEMS database using ICH E2B(R3) data standards.
FOR FURTHER INFORMATION CONTACT: For information concerning drug
products and biological products regulated by the Center for Drug
Evaluation and Research: Quocbao Pham, Center for Drug Evaluation and
Research (HFD-430), Food and Drug Administration, 10903 New Hampshire
Ave., Building 22, Rm. 4491, Silver Spring, MD 20993-0002, (301)-796-
5384, <a href="/cdn-cgi/l/email-protection#5233373f2137212730123436337c3a3a217c353d24"><span class="__cf_email__" data-cfemail="a9c8ccc4daccdadccbe9cfcdc887c1c1da87cec6df">[email protected]</span></a>.
For information concerning biological products regulated by the
Center for Biologics Evaluation and Research: Phillip Kurs, Center for
Biologics Evaluation and Research, Food and Drug Administration, (240)-
402-7911.
SUPPLEMENTARY INFORMATION: FDA is announcing an updated data standard
requirement for the submission of postmarketing ICSR submissions for
human drug products, biological products, and drug- or biologic-led
combination products to the AEMS database via the ESG NextGen. Starting
October 1, 2026, postmarketing ICSR submissions for human drug
products, biological products, and drug- and biologic-led combination
products to the AEMS database via ESG NextGen must be reported using
the data standards provided in the ICH E2B(R3) Implementation Guidance
(available at <a href="https://www.fda.gov/media/81904/download">https://www.fda.gov/media/81904/download</a>), which
incorporates by reference the guidance for industry and technical
specifications document entitled ``FDA Regional Implementation Guide
for E2B(R3) Electronic Transmission of Individual Case Safety Reports
for Drug and Biological Products'' (ICH E2B(R3) FDA Regional
Implementation Guidance) (available at <a href="https://www.fda.gov/media/180748/download">https://www.fda.gov/media/180748/download</a>). The ICH E2B(R3) Implementation Guidance and ICH
E2B(R3) FDA Regional Implementation Guidance were issued to improve the
quality of data in ICSR submissions and to enable improved handling and
analyses of ICSRs. Differences between ICH E2B(R2) and ICH E2B(R3)
include, for example: new, changed, and expanded data elements;
assessment of seriousness at the event level, rather than the case
level; and embedding of attachments in the ICSR rather than providing
separately.
FDA postmarketing safety reporting regulations for human drug and
biological products require that persons subject to mandatory
postmarketing reporting requirements for human drug products,
biological products, and drug- or biologic-led combination products
submit ICSRs in an electronic format that FDA can process, review, and
archive. See 21 CFR 4.102, 230.220(c)(1), 310.305(e)(1), 314.80(g)(1),
314.81(b)(3)(v)(F)(1), 314.98, 329.100(c)(1), and 600.80(h)(1). The
regulations explain that FDA will issue guidance on how to provide the
electronic submission of safety reports, including ICSRs and ICSR
attachments.
In the guidance for industry entitled ``Providing Submissions in
Electronic Format--Postmarketing Safety Reports'' (eSRR Guidance)
(available at <a href="https://www.fda.gov/media/71176/download">https://www.fda.gov/media/71176/download</a>), FDA provides
two options for electronic
[[Page 17285]]
submission of ICSRs and ICSR attachments to AEMS: (1) direct submission
through the ESG NextGen, or (2) submission through the Safety Reporting
Portal (SRP). The SRP enables submission of ICSRs and ICSR attachments
by applicants, specified nonapplicants, and responsible persons for
companies with reporting requirements who do not have ICH E2B(R3) data
standards capability. This notice regarding the use of ICH E2B(R3) data
standards applies only to submission of ICSRs and ICSR attachments
through the ESG NextGen. The eSRR Guidance incorporates by reference
the technical specifications described in the ICH E2B(R3) FDA Regional
Implementation Guidance, which addresses topics such as data elements,
electronic transport format, and types of ICSR attachments and is
periodically updated. To ensure that you have the most recent version
of the technical specifications document and for additional information
on electronic submissions to AEMS, check the FDA Adverse Event
Monitoring System (AEMS) Electronic Submissions web page at <a href="https://www.fda.gov/drugs/fda-adverse-event-monitoring-system-aems/fda-adverse-event-monitoring-system-aems-electronic-submissions">https://www.fda.gov/drugs/fda-adverse-event-monitoring-system-aems/fda-adverse-event-monitoring-system-aems-electronic-submissions</a>.
The technical specifications document entitled ``Specifications for
Preparing and Submitting Electronic ICSRs and ICSR Attachments''
(available at <a href="https://www.fda.gov/media/132096/download">https://www.fda.gov/media/132096/download</a>) discusses how
ICSRs and ICSR attachments should be electronically prepared in
accordance with the ICH E2B(R2) data standards, which are the data
standards that FDA will continue to accept through September 30, 2026.
In January 2024, FDA began accepting electronic submissions of
postmarketing ICSRs for human drug products, biological products, and
drug- or biologic-led combination products submitted to AEMS in
electronic format using the ICH E2B(R3) data standards and announced
that submitters could continue to submit using E2B(R2) standards for an
additional two years during the E2B(R3) implementation period. To
facilitate implementation and enhance efficiency and alignment with
internationally harmonized data standards, FDA is requiring that ICSRs
submitted through ESG NextGen must be in the ICH E2B(R3) data standards
beginning on October 1, 2026, unless earlier transition to ICH E2B(R3)
data standards is needed to accommodate reporting requirements (see,
for example, 21 CFR 314.81(b)(3)(v), added by the final rule entitled
``Nonprescription Drug Product With an Additional Condition for
Nonprescription Use'' (89 FR 105288, December 26, 2024)).
We intend to no longer accept postmarketing ICSRs using ICH E2B(R2)
data standards for human drug products, biological products, and drug-
or biologic-led combination products after September 30, 2026. Once an
applicant, specified nonapplicant, or responsible person for a company
with reporting requirements has begun submitting ICSRs in the ICH
E2B(R3) data standards format, all ICSR submissions are expected to use
this data standard. For general questions or assistance, see FOR
FURTHER INFORMATION CONTACT or contact <a href="/cdn-cgi/l/email-protection#5c3d39312f392f293e1c3a383d7234342f723b332a"><span class="__cf_email__" data-cfemail="046561697761777166446260652a6c6c772a636b72">[email protected]</span></a>.
(Authority: 21 CFR 4.102, 230.220(c)(1), 310.305(e)(1),
314.80(g)(1), 314.81(b)(3)(v)(F)(1), 314.98, 329.100(c)(1), and
600.80(h)(1))
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-06660 Filed 4-3-26; 8:45 am]
BILLING CODE 4164-01-P
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