1. Home
  2. Drugs
  3. Guidance, Compliance, & Regulatory Information
  4. Surveillance: Post Drug-Approval Activities
  5. FDA Adverse Event Monitoring System (AEMS)
  6. FDA Adverse Event Monitoring System (AEMS) Electronic Submissions
  1. FDA Adverse Event Monitoring System (AEMS)

FDA Adverse Event Monitoring System (AEMS) Electronic Submissions

[Formerly FDA Adverse Event Reporting System (FAERS)]

FDA Adverse Event Monitoring System (AEMS)

FDA is implementing the Adverse Event Monitoring System (AEMS) to consolidate multiple disparate reporting systems currently used across all FDA-regulated product categories, including medical products, vaccines, devices, tobacco, food, cosmetics, and veterinary medicines. 

This unified platform is designed to enhance data quality and consistency through standardized reporting protocols, streamline reporting processes to reduce administrative burden on both internal FDA staff and external stakeholders, and strengthen safety surveillance capabilities through advanced case processing workflows, AI-based redaction and digitization tools, enhanced analytics, and comprehensive cross-product surveillance. 

Beyond adverse event reporting, AEMS will serve as a centralized platform for managing consumer complaints, regulatory misconduct reports, and whistleblower submissions across all FDA centers. This comprehensive approach will enable more effective safety monitoring, facilitate trend identification across diverse product categories, and support timely regulatory decision-making to protect public health through improved data integration and analysis capabilities.

This page is intended to assist industry when making certain regulatory submissions in electronic format to the FDA’s Adverse Event Monitoring System (AEMS) database for the Center for Drug Evaluation and Research (CDER) and, the Center for Biologics Evaluation and Research (CBER).

On January 16, 2024, FDA began accepting electronic submissions of both expedited and non-expedited postmarketing individual case safety reports (ICSRs) for human drugs, including biological products regulated by CDER, in electronic format using the E2B(R3) data standard endorsed by the International Council for Harmonisation (ICH) and adopted by FDA.

On April 1, 2024, FDA began accepting electronic submissions of premarketing (IND study or IND-exempt BA/BE study) individual case safety reports (ICSRs) in electronic format using ICH E2B(R3) standards. 

On April 6, 2026, FDA announced that starting October 1, 2026, postmarketing ICSRs for human drug products, biological products, and drug- or biologic-led combination products that are submitted via the Electronic Submissions Gateway Next Generation (ESG NextGen) must be reported using the E2B(R3) data standards (see 91 FR 17284). This announcement extends the previously recommended E2B(R3) implementation period by six months. FDA will continue to accept ICSRs prepared in accordance with the E2B(R2) data standards through September 30, 2026, by companies that have not yet transitioned to use of E2B(R3) data standards. Once a company with reporting requirements has begun submitting ICSRs in the E2B(R3) data standards format, all ICSR submissions are expected to use this data standard. 

For information on how to submit serious adverse event reports (SAERs) associated with the use of cosmetic products, please visit the How to Report a Cosmetic Product Related Complaint web page.

The following timelines apply to companies submitting ICSRs electronically using database-to-database transmission (E2B).

Timelines

  • Postmarketing Safety Reporting for human drug and biological products using the E2B standard:
    • On June 10, 2014, FDA issued a final rule Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements, requiring industry to submit postmarketing safety reports for human drugs and biological products in an electronic format that FDA can process, review, and archive.
    • On January 16, 2024, FDA began accepting electronic submissions of both expedited and non-expedited postmarketing ICSRs for human drug products, biological products, and drug- and biologic-led combination products, in electronic format using the E2B(R3) data standards endorsed by ICH and adopted by FDA. 
    • Submitters to AEMS may continue to submit using E2B(R2) data standards during the E2B(R3) implementation period through September 30, 2026. 
    • Beginning October 1, 2026, all ICSRs submitted via the ESG NextGen must be submitted to the AEMS database using the E2B(R3) data standards. 
    • Once your company has begun submitting using the E2B(R3) standard all ICSR submissions are expected to use this data standard.
    • If you are submitting ICSRs via the Safety Reporting Portal (SRP) no action is required.
  • Premarketing Reporting (IND safety reports) using the E2B standard:
  • Premarketing Reporting (IND-exempt BA/BE safety reports) using the E2B standard:
    • The electronic submission of the ICSRs from IND-exempt BA/BE studies is a voluntary option for submission.
    • As you prepare to submit ICSRs electronically, continue to submit IND-exempt BA/BE safety reports on Form FDA-3500A MedWatch to ogd-premarketsafetyreports@fda.hhs.gov
    • Please see the guidance for industry titled Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies for instructions for the electronic submission of expedited individual case safety reports (ICSRs) from investigational new drug (IND)-exempt bioavailability (BA)/bioequivalence (BE) studies conducted to support abbreviated new drug applications (ANDAs).

Submitting Individual Case Safety Reports (ICSRs), Periodic Safety Reports (PSRs):

1. Submitting ICSRs

You have two options for submitting ICSRs electronically:

Option A: Database-to-Database Transmission (“E2B”)

ICSRs should be submitted in XML format using the one of the standards below via Electronic Submission Gateway (ESG):

Option B: Safety Reporting Portal (SRP)

Applicants for human drug products, biological products, cosmetic products, and responsible persons for companies with reporting requirements who do not have E2B capability may submit premarketing ICSRs, postmarketing ICSRs and respective attachments electronically via SRP by manually entering the data into a web form. To submit via SRP, you must first establish an SRP account. A Gateway partner (i.e., a company that submits ICSRs electronically via the ESG) cannot use SRP to submit ICSRs, and respective attachments.

For cosmetic products, the SRP account must be established by or on behalf of the responsible person whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.

Steps for requesting an SRP account

Contact aemsesub@fda.hhs.gov to advise FDA of your intent to begin submitting via the SRP and establish an account.

SRP account activation

  • Your account will be activated in about 7 to 10 business days from the date of request.
  • You will be notified via email with the subject line “SRP Account Activation” that will include the Web link to the SRP portal along with your account information.
  • After receiving this email, your account will be considered active, and you may begin submitting your ICSR via SRP.

2. Submitting PSRs

Please note that a PSR submission is comprised of both a descriptive portion and the non-expedited ICSRs received during the reporting interval of the PSR (21 CFR 314.80(c)(2) and 600.80(c)(2)).

  • Descriptive Portion:
  • Non-expedited ICSRs:
    • Must be submitted as described above for electronic submission of ICSRs and on or before the PSR due date. Please do NOT re-submit any ICSRs that were previously submitted.

Resources

Back to Top