Adverse Events Reporting System (AERS) Electronic Submissions

Introduction to the FDA AERS Electronic Submissions Website

This site provides drug and therapeutic biological product manufacturers, distributors, packers, and other interested parties with information about FDA Adverse Event Reporting System (AERS) electronic submissions and instructions on how to electronically submit postmarketing individual case safety reports (ICSRs), with and without attachments. 

Since 2000, FDA has accepted ICSRs electronically.  Currently, FDA only accepts electronic submissions of ISCRs in the XML format, prepared in accordance with International Conference on Harmonisation-E2B (ICH E2B) (PDF - 266KB), for direct database-to-database transmission of information using standardized (ICH E2B(M)) data elements.  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.

FDA will not accept ICSRs that are submitted electronically in formats other than XML.  Please note that attachments to ICSRs, however, are submitted electronically in formats other than XML.  Sections 1-3 below provide more detailed information on the electronic submission of ICSRs and ICSR attachments as well as links to reference documents.

1.  Electronic Submission of ICSRs: Format

A.  XML is the only acceptable format

The only permissible format for the electronic submission of ICSRs is the XML format.  XML requires specialized formatting using a standard structure. See document “Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments" (PDF - 84KB). XML files are submitted to the FDA via the Electronic Submissions Gateway (ESG).

B.  For instructions on the steps to take to begin submitting ICSRs in the XML format, please see:  "Steps to Submitting ICSRs Electronically in the XML Format”

C.  Submission of ICSRs in an eCTD will not be accepted (e.g., PDFs of FDA Form 3500A)

FDA is unable to accept ICSRs submitted as part of an eCTD, either as individual files or attached to other reports, such as the periodic safety report (periodic adverse drug experience report, periodic adverse experience report, or Periodic Safety Update Report).  The periodic safety report in module 5.3.6 of the eCTD must not contain the ICSRs (e.g., PDFs of FDA Form 3500A).  You should, however, indicate in the periodic safety report how the ICSRs have been submitted (on paper to the Central Document Room or electronically as XML files to the ESG). More information on eCTD   

2.  Electronic submission of Attachments to ICSRs

A.  Attachments to ICSRs may be submitted either on physical media or through the ESG

i. To electronically submit ISCR attachments on physical media, see page 8 of the document “Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments" (PDF - 84KB) .

ii. To electronically submit ICSR attachments through the ESG, see Electronic Submissions Gateway.

B.  What is considered to be an ICSR attachment?

Attachments to ICSRs include supporting information for ICSRs such as relevant hospital discharge summaries and autopsy reports/death certificates and published articles for ICSRs based on scientific literature. 

3.  Not yet ready for electronic Reporting of ICSRs in the XML format?

XML requires specialized formatting using a standard structure. If you are not ready to electronically submit ICSRs in the XML format, you must submit your ICSRs on paper using the appropriate FDA form (21 CFR 314.80(f) and 21 CFR 600.80(f)). The address for paper submissions of ICSRs is:

FDA/Central Document Room
Attn: AERS 3500A Reports Production
5901-B Ammendale Rd.
Beltsville, MD  20705-1266