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  1. Vaccines, Blood & Biologics

Electronic Submission of Postmarket Safety Reports

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 following documents:

Follow the steps below for submitting ICSRs to the FDA's electronic Vaccine Adverse Event Reporting System (eVAERS).

Step 1: Contact the CBER ICSR Submissions Coordinator (CBERICSRSubmissions@fda.hhs.gov) to inform FDA of your intent to begin submitting vaccine ICSRs electronically.

Step 2: Review the relevant guidances and technical specifications that are posted at the CBER Vaccine ICSR Implementation web page: http://www.fda.gov/forindustry/electronicsubmissionsgateway/ucm387293.htm

Questions pertaining to eVAERS submission requirements and process can be sent to the CBER ICSR Submission Coordinator.

Step 3: FDA ESG Transaction Partner Registration

Refer to the FDA ESG User Guide for general information about FDA Electronic Submissions Gateway (ESG), and apply for an ESG Transaction Partner account (i.e., a WebTrader or AS2 B2B account) at: https://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/CreateanESGAccount/default.htm
 

During the registration process, you will need to complete two levels of testing: (1) Connectivity testing and (2) Guidance-compliant testing (both of which occur in the FDA ESG test environment).

Before submitting your guidance-compliant testing submission, notify the CBER ICSR Submissions Coordinator of a planned schedule for sending your guidance-compliant test submissions, and then follows the steps below:

  1. Create vaccine ICSR files using the FDA’s eSubmitter tool (which can be downloaded at http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm108165.htm) or other appropriate tool in accordance with eVAERS technical specification;
  2. Submit the test file to eVAERS via the FDA ESG using the appropriate CBER gateway routing identifier (ID):
    • WebTrader Accounts: CBER VAERS
    • AS/2 B2B Accounts: CBER_VAERS
  3. Ensure that you receive an ESG MDN (ACK 1) and a CBER receipt acknowledgement (ACK 2), both of which usually occur within 24 hours of submission, and a third acknowledgment message (ACK 3) with eVAERS file validation results within 2 working days of submission. But:
    • If you do not receive ACK 1 and/or ACK 2, contact the FDA ESG Help Desk (ESGHelpDesk@fda.hhs.gov)
    • If you do not receive ACK 3, contact the CBER ICSR Submissions Coordinator.
  4. If any test ICSR fails validation (per ACK 3), make the necessary correction(s) and submit the corrected ICSR files to eVAERS (repeat of steps 1-4).

Step 4: Once you have passed the testing phase, an FDA ESG account will be set up allowing you to send submissions to FDA using the FDA ESG production system.

Step 5: After obtaining a production account, you may submit ICSRs to the Agency on a regular basis in compliance with regulatory timelines and requirements.