Vaccines, Blood & Biologics

Individual Case Safety Reports (ICSR) - Specifications

This page provides drug and therapeutic biological product manufacturers, distributors, packers, and other interested parties with information about FDA Adverse Event Reporting System (FAERS) and Vaccine Adverse Event Reporting System (VAERS) electronic submissions and instructions on how to electronically submit postmarketing Individual Case Safety Reports (ICSRs), with and without attachments. FDA only accepts electronic submissions of ICSRs in the XML format.

ICSR content and format requirements for drug and biologics reporting to FAERS is based upon the International Conference on Harmonisation (ICH) E2B(R2) specification for direct database-to-database transmission of information using standardized ICH E2B(M) data elements. ICSR content and format requirements for VAERS is based upon the revised ICH E2B(R3) Implementation Guide and FDA CBER E2B(R3) Regional Implementation Technical Specifications Document. FDA encourages electronic submissions of ICSRs because it is a cost-effective, efficient alternative to paper-based reporting that allows for harmonized reporting among applicants worldwide.

Questions or comments pertaining to the ICH E2B(R3) Implementation Guide should be addressed to: www.ich.org

Questions or comments pertaining to ICSR specifications should be sent to the appropriate FDA reporting program as follows:

For FAERS Reporting: FAERSESUB@fda.hhs.gov

For VAERS Reporting: CBERICSRSubmissions@fda.hhs.gov

FDA will not accept ICSRs that are submitted electronically in formats other than XML. ICSR attachments can be submitted electronically in formats other than XML such as Portable Document Format (.PDF) or Joint Photographic Experts Group (.JPEG). The information below describes the process for initiating electronic ICSR and ICSR attachments and links to other important reference documents.


Steps to Submitting ICSRs Electronically in the XML Format
Please follow these steps to begin submitting ICSRs electronically in the XML format:

Step 1:

Step 2:

Step 3:

Step 4:
Submit ICSRs through the gateway during the gateway hours of operation.  For more information regarding the FDA ESG program, operating status and Frequently Asked Questions refer to the ESG Gateway page: http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 08/20/2014
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