FDA Adverse Event Reporting System (FAERS) Electronic Submissions

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This page provides drug and non-vaccine biologic manufacturers, distributors, packagers, contract facilities, and other interested parties with information about FDA Adverse Event Reporting System (FAERS) electronic submissions. and instructions on how to electronically submit post-market Individual Case Safety Reports (ICSRs) with and without attachments.

Since 2000, the FDA has accepted electronic submissions of expedited and non-expedited Individual Case Safety Reports (ICSRs) for human drugs and non-vaccine biologics. To date, FDA has only accepted electronic submissions from ISCR in XML format, prepared in accordance with the International Conference on Harmonization-E2B (ICH E2B) (PDF – 266 KB) to transmit information directly from one database to another using standards (ICH E2B(M)) data elements.

As of June 10, 2015*, the FDA requires applicants to electronically submit all ICSRs, ICSR Attachments, and Periodic Safety Reports. There are two options for submitting ICSRs electronically:

  • Database-to-database (“E2B”) transmission
  • The Safety Reporting Portal (SRP) by manually entering data through our SRP portal.
  • Attachments: For both methods, we will only accept attachments in PDF format.

* The FDA issued a final rule on June 10, 2014, which requires industry to submit post-market safety reports in an electronic format. See the rule on: FDA releases final rule on post-market safety report in electronic format (FDA records).

Submit Individual Case Safety Reports (ICSR), ICSR Attachments and Periodic Safety Reports (PSR)

  1. Electronic submission of ICSRs
    You have 2 options to submit ICSRs electronically.

    ICSR Option A: Database-to-database (“E2B”) transmission

    ICSR Option B: Safety Reporting Portal (SRP)

    Applicants and non-applicants who do not have database-to-database capability can submit electronic ICSRs using the SRP. To submit via SRP, you must have an account to access the portal site. Those who are Gateway partners cannot use SRP. Gateway Partners are companies that submit electronically through the e-Submission Gateway.

    Steps to Apply for an SRP Account

    SRP account activation

    • Your account will be activated in approximately 7-10 business days.
    • You will be notified by email with the subject line “SRP Account Activation” which will include the web link to the SRP Portal along with account information.
    • After you receive this email, your account will be considered active and you can start submitting reports.
  2. Submitting ICSR Attachments
    Attachments to ICSRs include supporting information for ICSRs such as hospital discharge summaries and relevant autopsy reports, death certificate, and published articles for ICSRs based on scientific literature.
    1. Database-to-Database (“E2B”) Transmission.
    2. Security Reporting Portal (SRP).
      • To submit ICSR attachments through the SRP, use the portal features that allow you to browse, select, and attach documents to an ICSR.
  3. Submission of Periodic Safety Reports (PSR)
    Periodic Safety Reports include a descriptive portion and non-expedited ICSRs (21 CFR 314.80 and 600.80), regardless of format.
    1. Descriptive part:
      • Use the Electronic Common Technical Document (eCTD) specifications to submit the descriptive part electronically.
      • Indicate in the descriptive section that the ICSRs were submitted electronically as XML files to the FDA’s Electronic Submissions Gateway (ESG) or through the Safety Reporting Portal (SRP).
    2. Non-accelerated ICSR: must be submitted as described above and no later than the periodic safety report due date. Do NOT submit previously submitted accelerated ICSRs.

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