Pre-production Approval Process:
If you have any question regarding submitting postmarketing Individual Case Safety Reports (ICSR) electronic submissions and the approval of production reporting, please contact the FAERS Electronic Submission Coordinator.
If you have any questions regarding the FDA Gateway setting-up Gateway account or transmission issues, for more information, see the FDA Electronic Submissions Gateway or contact ESGHelpDesk@fda.hhs.gov.
The testing of ICH E2B (R2) ICSR electronic submissions and the approval of production reporting process can be completed in a short timeframe. The FAERS dedication team can help you through each step of the testing and reporting process.
The first step is to send ten test files covering the listed below scenarios which will test, the E2B (R2) parsing, data validation and connectivity testing with the FDA gateway. After satisfactory completion of the testing, the Trading Partner can move into production without submitting duplicate paper reports.
ICSR Test Report Scenarios and Criteria:
In addition to the four minimum criteria, as stated in Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments [PDF] document, each test report should contain information for one or more of the categories using relevant ICH E2B (R2) data elements.
- Lab Test names
- Parent/child ICSR,
- Expedited ICSR
- Non-expedited (periodic reports) ICSR
- Initial ICSR
- Follow-up ICSR
- ICSR attachment (e.g., literature ICSR) using PDF file format
To trace your test reports, please send an email to the ESG Helpdesk and FAERS Electronic Submissions Coordinator and include the folloring information:
- Transmission date and time,
- Safety Report Id (Manufacturer Control Numbers (MCNs)),
- FDA ESG Core Id, and
- Sender Organization.
List of related FDA web-links for your review and implementation:
- Guidance for Industry Providing Regulatory Submissions in Electronic Format Postmarketing Individual Case Safety Reports [PDF]
- Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments [PDF]
- ICH E2B Specifications [PDF]
- DTD ICSRv-2.1
- DTD ICSR Acknowledgement v-1.1
- DTD PDF ICSR (Literature) Attachment
- Guidance on Providing Postmarket Non-Expedited ICSRs Submissions in Electronic Format [PDF]
- Technical Questions and Answers on Providing Postmarket Non-Expedited ICSRs Submissions in Electronic Format [PDF]
- Transmitting Electronic ICSRs and ICSR Attachments on Physical Media [PDF]