Updates for electronic submission of Individual Case Safety Reports (ICSR) to FAERS
Pre-market safety reports
**** On February 3, 2021, this webpage indicated that as of June 28, 2021, the FDA will begin accepting IND safety reports in E2B format. Please note that the date has been changed and the FDA will post a new date for voluntary submission of IND safety reports in the future. In the meantime, please continue to submit IND safety reports using the eCTD format. The E2B format will not be accepted until indicated on this web page, or until final guidelines are posted. ****
In preparation for receiving IND Safety Reports, the FDA has issued the following documents regarding the electronic submission of certain Investigational New Drug Application (IND) Safety Reports for Drugs and Biologics to FAERS. These documents are posted to help prepare the IND electronic safety report submission systems.
- Provide Electronic Regulatory Submissions: IND Safety Reports – Draft Guidance for Industry (October 2019)
- Electronic Submission of IND Safety Reports – Technical Compliance Guide (October 2019)
- The revised technical specification document Specifications for the preparation and submission of electronic ICSRs and ICSR attachments (April 2021). The FDA has revised this document to include data elements, descriptors, and descriptor values ââfor reporting certain IND safety reports as Individual Case Safety Reports (ICSRs).
For investigational drugs and biologics without an established name (i.e. INN or USAN name), or if the established name exceeds the established E2B character lengths, prior to submission of the IND safety reports to the FAERS, the sponsor must submit to the IND a general correspondence in eCTD Format to inform the FDA of how the product name will be submitted in the established E2B character lengths. Please refer to Electronic submission of IND safety reports – Technical compliance guide (October 2019) for more information.
Post-market safety reports
On April 7, 2021, this webpage indicated that as of June 28, 2021, the FDA will be implementing a new regional data element for the electronic submission of ICSRs. Please note that the date has been changed and the FDA will be posting a new date to implement the new regional data element. In the meantime, please continue to submit post-market safety reports using the Current DTD 2.1 or DTD 2.2 without the new regional element.
For assistance, contact the FAERS Electronic Submission Coordinator at [email protected]
This page provides drug and non-vaccine biologics manufacturers, distributors, packagers, outsourcing facilities and other interested parties with information on the Adverse Event Reporting System (FAERS) electronic submissions from the FDA and instructions on how to electronically submit Post-Market Individual Case Safety Reports (ICSRs) with and without attachments.
Since 2000, the FDA has accepted both expedited and non-expedited electronic individual safety report (ICSR) submissions for human drugs and non-vaccine biologics. To date, the FDA has only accepted electronic submissions of ISCR in XML format, prepared in accordance with the International Conference on Harmonization-E2B (ICH E2B) (PDF – 266KB) to transmit basic information directly from data to database using standard (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 issues final rule on post-market safety report in electronic format (FDA Archives).
Submit Individual Case Safety Reports (ICSR), ICSR Attachments, and Periodic Safety Reports (PSR)
Electronic submission of ICSRs
You have 2 options for submitting ICSRs electronically.
ICSR Option A: Database to Database Transmission (“E2B”)
ICSR Option B: Safety Reporting Portal (SRP)
Applicants and non-applicants who do not have the 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. Gateway partners cannot use SRP. Gateway partners are companies that submit electronically through the electronic submission gateway.
Steps to request an SRP account
Activation of the SRP account
- Your account will be activated in approximately 7-10 business days.
- You will be notified by email with the subject line âSRP Account Activationâ which will include the web link to the SRP Portal along with the account information.
- After receiving this email, your account will be considered active and you can start submitting reports.
- Submission of ICSR attachments
Attachments to ICSRs include information supporting ICSRs, such as hospital discharge summaries and relevant autopsy reports, death certificates, and published articles for ICSRs based on the scientific literature.
- Database to Database (“E2B”) transmission.
- Safety 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.
- Submission of periodic safety reports (PSR)
The periodic safety reports include a descriptive part and non-accelerated ICSRs (21 CFR 314.80 and 600.80), regardless of the format.
- Descriptive part:
- Use the specifications of the Electronic Common Technical Document (eCTD) to submit the descriptive part electronically.
- Indicate in the description that the ICSRs were submitted electronically as XML files to the FDA Electronic Submissions Gateway (ESG) or through the Safety Reporting Portal (SRP).
- Unaccelerated ICSR: must be submitted as described above and no later than the due date of the periodic safety report. Do NOT submit previously submitted expedited ICSRs.
- Descriptive part:
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