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  1. Development & Approval Process (CBER)

Electronic Submission of Postmarket Safety Reports

This page provides human drug and biological product manufacturers, distributors, packers, and other parties subject to mandatory reporting requirements with the instructions on how to electronically submit postmarket Individual Case Safety Reports (ICSRs) to the FDA. The instructions for submitting drug and non-vaccine biologics ICSRs are different from those for submitting vaccine ICSRs.

Drug and Non-vaccine Biologics:

ICSR content and format requirements for drug and non-vaccine biologics postmarket reporting are based upon the International Council on Harmonisation (ICH) E2B(R2) specifications.

Visit the FDA Adverse Event Reporting System (FAERS) Electronic Submissions website for step-by-step instructions for submitting drug and non-vaccine biologics ICSRs to the FDA: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation
/Surveillance/AdverseDrugEffects/ucm115894.htm

Questions or comments pertaining to FAERS can be sent to: FAERSESUB@fda.hhs.gov

Vaccines:

ICSR content and format requirements for vaccine postmarket reporting are based upon the International Council on Harmonisation (ICH) E2B(R2) specifications.

Visit the CBER Vaccine ICSR Implementation website for step-by-step instructions for submitting drug and non-vaccine biologics ICSRs to the FDA.

Questions or comments pertaining to VAERS can be sent to: CBERICSRSubmissions@fda.hhs.gov

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