Updates for Electronic Submission of Individual Case Safety Reports (ICSRs) to FAERS
Premarketing Safety Reporting
****On February 3, 2021 this web page indicated that as of June 28, 2021, FDA will begin accepting IND Safety Reports in E2B format. Please note that the date has been changed and FDA will post a new date for the voluntary submission of IND Safety Reports in the future. In the meantime, please continue to submit IND Safety Reports using eCTD format. E2B format will not be accepted until indicated on this web page, or until final guidance is published.****
In preparation for the receipt of IND Safety Reports, FDA has posted the following documents regarding the electronic submission of certain investigational new drug applications (INDs) safety reports for drugs and biological products to FAERS. These documents are posted to help prepare systems for electronic submissions of IND safety reports.
- Providing Regulatory Submissions in Electronic Format: IND Safety Reports - Draft Guidance for Industry (October 2019)
- Electronic Submission of IND Safety Reports - Technical Conformance Guide (October 2019)
- The revised technical specifications document Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments (December 2020). FDA has revised this document to include data elements, descriptors, and descriptor values for reporting certain IND safety reports as individual case safety reports (ICSRs).
For investigational drugs and biological products without an established name (i.e. INN or USAN name), or if the established name exceeds established E2B character lengths, prior to submission of IND safety reports to FAERS, the sponsor should submit to the IND a general correspondence in eCTD format to inform FDA of how the product name will be submitted within the established E2B character lengths. Please refer to the Electronic Submission of IND Safety Reports - Technical Conformance Guide (October 2019) for further information.
Postmarketing Safety Reporting
Starting June 28, 2021, FDA is implementing a new mandatory regional data element for the electronic submission of ICSRs. The new regional data element, A.1.FDA.16 (FDA Safety Report Type), will distinguish the safety report type as IND Safety Reports, IND Exempt BA/BE Safety Reports, or Postmarketing Safety Reports. For more information about the regional data element, A.1.FDA.16 (FDA Safety Report Type), and submission rules, please see the revised technical specifications document Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments (December 2020) and revised DTD 2.1 OR ( text file format) and DTD 2.2. OR (text file format)
For assistance contact the FAERS electronic submission coordinator at email@example.com
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 32 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.
- Database-to-Database Transmission (“E2B”).
- 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
- Providing Regulatory Submissions in Electronic Format: IND Safety Reports: Guidance for Industry
- Electronic Submission of IND Safety Reports Technical Conformance Guide
- FAQ: Combination Products (PDF - 92 KB)
- 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)