U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drugs
  3. Guidance, Compliance, & Regulatory Information
  4. Surveillance: Post Drug-Approval Activities
  5. Questions and Answers on FDA's Adverse Event Reporting System (FAERS)
  6. FDA Adverse Event Reporting System (FAERS) Electronic Submissions – E2B(R3) Standards
  1. Questions and Answers on FDA's Adverse Event Reporting System (FAERS)

FDA Adverse Event Reporting System (FAERS) Electronic Submissions – E2B(R3) Standards

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 Reporting System (FAERS) database using the E2B(R3) standard.

For submitting premarketing and postmarketing ICSRs to FAERS refer the International Council for Harmonisation (ICH) - E2B(R3) Individual Case Safety Report (ICSR) Specification and Related Files along with FDA’s regional implementation documents and resources listed in the sections below.

Premarketing Safety Reporting

In preparation for the electronic transmission of premarketing safety reports in the ICH E2B(R3) format, 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 FAERS. These documents are posted to help sponsors prepare their systems for electronic submission of IND safety reports in the E2B(R3) standard.

  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. Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies - Guidance for Industry (April 2024)
  5. FDA E2B(R3) Core and Regional Data Elements and Business Rules (Excel file April 2024)
  6. FDA ICSR XML Instances (zip file February 2024)

Postmarketing Safety Reporting

In preparation for the receipt of postmarketing safety reports in the E2B(R3) format, FDA has posted the following documents regarding the electronic submission of ICSRs for drug and biological products to FAERS. These documents are posted to help prepare systems for electronic submissions of postmarketing safety reports using the E2B(R3) standard.

  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 February 2024)
  5. Providing Submissions in Electronic Format – Postmarketing Safety Reports: Guidance for Industry (April 2022)

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 in E2B(R3) format, please contact the FAERS electronic submission coordinator at faersesub@fda.hhs.gov.

Resources For You

 
Back to Top