Drugs

FDA Adverse Events Reporting System (FAERS) Electronic Submissions

This page provides drug and therapeutic biological product manufacturers, distributors, packers, and other interested parties with information about FDA Adverse Event Reporting System (FAERS) 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

  2. Electronic submission of Attachments to ICSRs

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

    • 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. Submission of Periodic reports:  Electronic versus Paper

    Periodic reports have the following parts; each part may be submitted electronically or on paper.

    • Descriptive portion:
      Format is Periodic Adverse (Drug) Experience Report1, or the ICH-E2C Periodic Safety Update Report (allowed with approved waiver) 
       
    • Individual case safety reports (ICSRs), with or without attachments:
      Submitted either electronically using ICH E2B standards or submitted on paper using FDA Form 3500A (if you are not yet ready to submit electronically)
       

    A.  If you are submitting ICSRs electronically, you can submit the descriptive portion electronically or on paper.

    • Electronic submission of descriptive portion
      Use Electronic Common Technical Document (eCTD), specifications, module 5.3.6 for electronic submission of the descriptive portion. Indicate in the descriptive portion that the ICSRs have been submitted electronically as XML files to the FDA Electronic Submissions Gateway (ESG).

       
    • Paper submission of descriptive portion
      Mail two copies of paper submissions of the descriptive portion to the Central Document Room (CDR) at the following address, and indicate in the descriptive portion of your Periodic report that the ICSRs have been submitted electronically as XML files to the FDA Electronic Submissions Gateway (ESG).

      FDA/Central Document Room
      5901-B Ammendale Rd.
      Beltsville, MD  20705-1266

       

    B.  If you are submitting ICSRs on paper (Form FDA 3500A), because you are not yet ready to submit ICSRs electronically, and you are

    • Submitting the descriptive portion of your Periodic report electronically
      • Mail two copies of the ICSRs (i.e. two complete sets of the paper 3500A forms) to the CDR at the address above.
      • Add to the CDR address: Attn: AERS 3500A Reports Production.
      • Indicate in the electronically submitted descriptive portion of the Periodic report that you have submitted (mailed) the ICSRs (paper 3500A forms) to the CDR.

           Submission of ICSRs to the eCTD  (e.g. PDFs of FDA Form 3500A) will not be accepted.

    • Submitting the descriptive portion of your Periodic report on paper
      • Attach the ICSRs (3500A forms) to the descriptive portion.
      • Mail two copies of the descriptive portion with attached ICSRs to the CDR at the address above.

         


1 Periodic adverse drug experience reports or Periodic adverse experience reports, as described in 21 CFR 314.80 and 600.80, respectively.

Page Last Updated: 10/16/2014
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