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  5. Questions and Answers on FDA's Adverse Event Reporting System (FAERS)
  6. FDA Adverse Event Reporting System (FAERS) Electronic Submissions
  1. Questions and Answers on FDA's Adverse Event Reporting System (FAERS)

FDA Adverse Event Reporting System (FAERS) Electronic Submissions

This page is intended to assist industry when making certain regulatory submissions in electronic format to the FDA’s Adverse Event Reporting System (FAERS) database for the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

On January 16, 2024, FDA began accepting electronic submissions of both expedited and non-expedited postmarketing individual case safety reports (ICSRs) for human drugs, including biological products regulated by CDER, in electronic format using the E2B(R3) standard endorsed by the International Council for Harmonisation (ICH) and adopted by FDA.

In addition, on April 1, 2024, FDA began accepting electronic submissions of premarketing (IND study or IND-exempt BA/BE study) individual case safety reports (ICSRs) in electronic format using ICH E2B(R3) standard. The following timelines apply to companies submitting ICSRs electronically using database-to-database transmission (E2B).

Timelines

  • Postmarketing Safety Reporting for human drug and biological products using the E2B standard:
    • On January 16, 2024, FDA implemented the E2B(R3) standard for electronic transmission of ICSRs and submitters have until April 1, 2026, to implement E2B(R3) standard for electronic transmission.
    • Submitters to FAERS may continue to submit using E2B(R2) data standards for two (2) years during the E2B(R3) implementation period.
    • Continue to submit postmarketing ICSRs in E2B(R2) format as you prepare to submit ICSRs using E2B(R3) data standards.
    • Once your company has begun submitting in the E2B(R3) standard, your company may not revert to legacy methods or standards 
  • If you are submitting ICSRs via the Safety Reporting Portal (SRP) no action is required.
  • FDA issued a final rule on June 10, 2014, requiring industry to submit postmarketing safety reports in an electronic format.
  • Premarketing Reporting (IND safety reports) using the E2B standard:
    • Submitters have until April 1, 2026, (24 months after publication of the final guidance for industry, Providing Regulatory Submissions in Electronic Format: IND Safety Reports) to comply with electronic submission requirements for IND safety reports under 21 CFR 312.32(c)(1)(i) for serious and unexpected suspected adverse reactions.
    • As you prepare to submit ICSRs electronically during the voluntary submission period, sponsors may continue to submit a PDF copy of the Form FDA-3500A MedWatch form using the eCTD standard until April 1, 2026.
  • Premarketing Reporting (IND-exempt BA/BE safety reports) using the E2B standard:
    • The electronic submission of the ICSRs from IND-exempt BA/BE studies is a voluntary option for submission.
    • As you prepare to submit ICSRs electronically, continue to submit IND-exempt BA/BE safety reports on Form FDA-3500A MedWatch to ogd-premarketsafetyreports@fda.hhs.gov

Submitting Individual Case Safety Reports (ICSRs), Periodic Safety Reports (PSRs):

1. Submitting ICSRs

  You have two options for submitting ICSRs electronically:

  Option A: Database-to-Database Transmission (“E2B”)

  ICSRs should be submitted in XML format using the one of the standards below via  Electronic Submission Gateway (ESG):

  • E2B(R3) standard: in accordance with the ICH E2B(R3) and FDA’s regional technical specifications.
  • E2B(R2) standard: only for postmarketing ICSRs until April 1, 2026, during the E2B(R3) implementation period.

  Option B: Safety Reporting Portal (SRP)

Applicants for human drug products, biological products, and responsible persons for companies with reporting requirements who do not have E2B capability may submit postmarketing ICSRs and respective attachments electronically via SRP by manually entering the data into a web form. To submit via SRP, you must first establish an SRP account. A Gateway partner (i.e., a company that submits ICSRs electronically via the ESG) cannot use SRP to submit ICSRs, and respective attachments.

Steps for requesting an SRP account

Contact faersesub@fda.hhs.gov to advise FDA of your intent to begin submitting via the SRP and establish an account.

SRP account activation

  • Your account will be activated in about 7 to 10 business days from the date of request.
  • You will be notified via email with the subject line “SRP Account Activation” that will include the Web link to the SRP portal along with your account information.
  • After receiving this email, your account will be considered active, and you may begin submitting your ICSR via SRP.

2. Submitting PSRs

Please note that a PSR submission is comprised of both a descriptive portion and the non-expedited ICSRs received during the reporting interval of the PSR (21 CFR 314.80(c)(2) and 600.80(c)(2)).

  • Descriptive Portion:
    • Use Electronic Common Technical Document (eCTD) specifications to submit electronically.
    • Indicate in the descriptive portion that the ICSRs have been submitted electronically as XML files to the ESG or via the SRP.
  • Non-expedited ICSRs:
    • Must be submitted as described above for electronic submission of ICSRs and on or before the PSR due date. Please do NOT re-submit any ICSRs that were previously submitted.

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