FDA has posted the following documents regarding the submission of postmarketing safety reports to FDA Adverse Event Reporting System (FAERs) for combination products under the final rule Postmarketing Safety Reporting for Combination Products, hereafter referred to as the “final rule” (81 FR 92603).
- The revised technical specifications document Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments (PDF - 204KB). FDA has revised this document to include new data elements, descriptors, and descriptor values for reporting individual case safety reports (ICSRs) for combination products that have a drug or biological product (including therapeutic vaccines) constituent part and a device constituent part and that are marketed under an approved application or marketing authorization.
- The Postmarketing Safety Reporting for Combination Products Guidance for Industry and FDA Staff and the Compliance Policy for Combination Product Postmarketing Safety Reporting Immediately in Effect Guidance for Industry and FDA Staff which addresses how and when to comply with the final rule (see Postmarketing Safety Reporting for Combination Products).
- Electronic submission of ICSRs using Option A: Database-to-Database Transmission (“E2B”) and Option B: Safety Reporting Portal (SRP) are now available for use to also report combination product ICSRs.
This page provides drug and nonvaccine biological product manufacturers, distributors, packers, outsourcing facilities, 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 electronic submissions of both expedited and non-expedited Individual Case Safety Reports (ICSRs) for human drug and nonvaccine biologic products. To date, FDA has only accepted electronic submissions of ISCRs in the XML format, prepared in accordance with International Conference on Harmonisation-E2B (ICH E2B) (PDF - 266KB) to transmit information directly from database-to-database using standardized (ICH E2B(M)) data elements.
Starting June 10, 2015,* FDA is requiring that applicants electronically submit all ICSRs, ICSR attachments, and periodic safety reports. There are two options for submitting ICSRs electronically:
- Database-to-database transmission ( “E2B”)
- The Safety Reporting Portal (SRP) by manually entering the data via our SRP portal.
- Attachments: for both methods, we will only accept attachments in the PDF format.
*FDA issued a final rule on June 10, 2014, that requires industry to submit post-marketing safety reports in an electronic format. See the rule at: FDA issues final rule on postmarketing safety report in electronic format (FDA Archive).
Submitting Individual Case Safety Reports (ICSRs), ICSR Attachments, & Periodic Safety Reports (PSRs)
Electronic submission of ICSRs
You have the 2 options for submitting ICSRs electronically.
ICSR Option A: Database-to-Database Transmission (“E2B”)
- ICSRs must be submitted in the XML format.
- Attachments must be in the pdf format.
- See document “Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments" (PDF - 204KB). XML files are submitted to the FDA via the Electronic Submissions Gateway (ESG).
- For additional instruction on how to begin submitting ICSRs in the XML format, go to our document titled, "Steps to Submitting ICSRs Electronically in the XML Format."
ICSR Option B: Safety Reporting Portal (SRP)
Applicants and non-applicants who do not have database-to-database capability may 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 the SRP. Gateway partners are those companies that submit electronically via the Electronic Submission Gateway.
Steps for requesting an SRP account
- Contact FAERSESUB@fda.hhs.gov to advise FDA of your intent to begin submitting via the SRP.
SRP account activation
- Your account will be activated in about 7 to 10 business days.
- 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 account information.
- After receiving this email, your account will be considered active and you may begin submitting reports.
- Submitting ICSR Attachments
Attachments to ICSRs include supporting information for ICSRs such as relevant hospital discharge summaries and autopsy reports, death certificate, and published articles for ICSRs based on scientific literature.
- Database-to-Database Transmission (“E2B”).
- Submit attachments to ICSRs through the electronic submission gateway (ESG). See page 9 of the document “Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments" (PDF - 204KB).
- Safety Reporting Portal (SRP).
- To submit ICSR attachments via the SRP, use the features within the portal that allows you to browse, select, and attach documents to an ICSR.
- Submitting Periodic Safety Reports (PSR)
Periodic safety reports are comprised of a descriptive portion and non-expedited ICSRs (21 CFR 314.80 and 600.80), regardless of the format.
- Descriptive Portion:
- Use Electronic Common Technical Document (eCTD) specifications to submit the descriptive portion electronically.
- Indicate in the descriptive portion that the ICSRs have been submitted electronically as XML files to the FDA Electronic Submissions Gateway (ESG) or via the Safety Reporting Portal (SRP).
- Non-expedited ICSRs: must be submitted as described above and on or before the periodic safety report due date. Do NOT submit expedited ICSRs previously submitted.
- Descriptive Portion:
Resources For You
- FAERS Submissions Frequently Asked Questions
- Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards
- FAQs: Safety Reporting Portal
- FDA Regional Implementation Specifications for ICH E2B(R3) Reporting to the FDA Adverse Event Reporting System (FAERS)