Mandatory Reporting
Some professionals may be required by law to submit safety reports for specific circumstances. Some organizations are also required by statute or regulation to submit a safety report to the Federal Government.
When a report is required by statute or regulation, the report is called a "Mandatory report." Mandatory reports can be submitted using the following sites below.
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Safety Reporting Portal (SRP)
The Safety Reporting Portal (SRP) streamlines the process of reporting product safety issues to the FDA. The following mandatory reports can be submitted: Reportable Food, Animal Drug Safety Report, Gene Transfer Research Adverse Event Report, Small Pharmaceuticals Report, and Premarket Safety Report.
Safety Reporting Portal (SRP)Veterinary Adverse Event Report for manufacturers
Reporting of veterinary adverse events for manufacturers' information electronically.
Veterinary Adverse Event Report for manufacturersAdverse Event Monitoring System (AEMS)
Submit post-marketing individual case safety reports (ICSRs) of medicines for human use, including CDER-regulated biologics or pre-marketing individual case study reports (ICSRs) (IND study or IND-exempt BA/BE study).
Adverse Event Monitoring System (AEMS)Electronic Submissions Gateway NextGen (ESG NextGen)
The FDA ESG NextGen platform accepts electronic regulatory submissions. It enables the secure submission of premarket and postmarket regulatory information for review.
The FDA ESG NextGen sends information electronically to the FDA. Submissions travel through it to reach the right FDA Center or Office.
For assistance with ESG NextGen related items, please contact esgngsupport@fda.hhs.gov or visit https://www.fda.gov/industry/electronic-submissions-gateway