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  1. FDA Adverse Event Monitoring System (AEMS)

FDA Adverse Event Monitoring System (AEMS) – E2B(R3) Data Standards

[Formerly FDA Adverse Event Reporting System (FAERS)]

This page provides applicants, manufacturers, distributors, packers, outsourcing facilities, and other interested parties, information and instructions on how to electronically submit premarketing and postmarketing Individual Case Safety Reports (ICSRs) to the FDA Adverse Event Monitoring System (AEMS) database using the E2B(R3) data standards.

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.

On December 16, 2025, ICH published the Information Paper Regarding Alignment with ICH

E2D(R1) Guideline which explains the alignment of ICH E2B(R3) specifications with the E2D(R1) guidance. This information paper updates user guidance for ICH E2B(R3) data element C.1.3: Type of Report and data element C.5.4: Study Type Where Reaction(s) / Event(s) Were Observed. In addition, the information paper describes new values to classify solicited reports originating from patient support programs (see section 4.5 of the E2D(R1) guidance), market research programs (see section 4.6 of the E2D(R1) guidance) and organized data collection systems with source data from digital platforms (see section 4.3.2 of the E2D(R1) guidance). FDA AEMS is now accepting the new values for data element C.5.4: Study Type Where Reaction(s) / Event(s) Were Observed.

This Information Paper will be available until the update has been incorporated in FDA’s guidance for industry titled E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification.

Premarketing Safety Reporting

To help companies implement the E2B(R3) data standards for the electronic transmission of premarketing safety reports, FDA has posted the following documents regarding the electronic submission of ICSRs for certain investigational new drug application (IND) safety reports for drug and biological products and IND-exempt bioavailability/bioequivalence (BA/BE) safety reports to FDA AEMS:

  1. Providing Regulatory Submissions in Electronic Format: IND Safety Reports - Guidance for Industry (April 2024)
  2. Electronic Submission of IND Safety Reports - Technical Conformance Guide (April 2022)
  3. Technical Specifications Document - FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products (April 2024)
  4. Sponsor Responsibilities — Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies (Dec 2025)
  5. Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices (Dec 2025)
  6. Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies - Guidance for Industry (April 2024)
  7. FDA E2B(R3) Core and Regional Data Elements and Business Rules (Excel file April 2024)
  8. FDA ICSR XML Instances (zip file July 2024)

Postmarketing Safety Reporting

To help companies implement the E2B(R3) data standards for the electronic submission of postmarketing ICSRs, FDA has posted the following documents regarding the electronic submission of ICSRs for drug and biological products to FDA AEMS:

  1. Technical Specifications Document - FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products (April 2024)
  2. FDA E2B(R3) Core and Regional Data Elements and Business Rules (Excel file April 2024)
  3. FDA E2B(R3) Forward Compatible Rules (Excel file April 2022)
  4. FDA ICSR XML Instances (zip file July 2024)
  5. Providing Submissions in Electronic Format – Postmarketing Safety Reports: Guidance for Industry (April 2022)
  6. Information Paper Regarding Alignment with ICH E2D(R1) Guideline

FDA has provided the FDA E2B(R3) Validator tool to facilitate the validation of the E2B(R3) XML files generated from your safety database. This validator tool provides a web-based interface that enables submitters to submit an E2B(R3) XML file in a test environment and check the validity or correctness of the file. The validation status and results are displayed to the user in real-time. FDA also recommends submitters review the document Preparing for the electronic exchange of safety reports also available under the section Resources For You.

For questions related to electronic reporting of ICSRs using E2B(R3) data standards, please contact the AEMS electronic submission coordinator at aemsesub@fda.hhs.gov.

Resources For You

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