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  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 AEMS database for the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

On April 6, 2026, FDA announced that starting October 1, 2026, postmarketing individual case safety reports (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. 

Alignment with the ICH E2D(R1) Guideline

On March 6, 2026, FDA announced the availability of a guidance for industry titled E2D(R1) Postapproval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports (E2D(R1) guidance) (see 91 FR 10619). This guidance clarifies the use of new postapproval safety sources and updates terminology and standards for postapproval adverse event reporting.

FDA AEMS is now accepting the new values (4 = Patient Support Program, 5 = Market Research Program, 6 = Organised Data Collection System with source data from a digital platform) for data element C.5.4: Study Type Where Reaction(s) / Event(s) Were Observed.

Timelines

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

  • Postmarketing Safety Reporting for human drug and biological products using the E2B data standards:
    • 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. 
    • Beginning October 1, 2026, all ICSRs submitted via the ESG NextGen must be submitted to the AEMS database using E2B(R3) data standards. 
    • If you are submitting ICSRs via the Safety Reporting Portal (SRP) no action is required.
  • Premarketing Reporting (IND safety reports) using the E2B data standards:
  • Premarketing Reporting (IND-exempt bioavailability (BA)/Bioequivalence (BE) safety reports) using the E2B data standards:

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 E2B(R3) data standards below via ESG NextGen. These documents are posted on the FDA AEMS - E2B(R3) data standards web page to help companies implement the E2B(R3) data standards for the electronic submission of postmarketing ICSRs:

Option B: Safety Reporting Portal (SRP)

Applicants for human drug products, biological 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 NextGen) cannot use SRP to submit ICSRs, and respective attachments.

  • 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 (see 21 CFR 314.80(c)(2) and 600.80(c)(2)).

  • Descriptive Portion:
    • Use Electronic Common Technical Document (eCTD) specifications to submit electronically.
    • Indicate in the descriptive portion that the ICSRs have been submitted electronically as XML files to the ESG NextGen or via the SRP.
  • 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.

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