US FDA Adverse Event Reporting System (FAERS) Electronic Submissions

At the end of April 2022, the FDA finalized and published their E2B(R3) guidelines for submitting safety reports. On 04 May 2022, the relevant FDA webpage was updated to include technical files and the finalized guidelines themselves.

The aim of the new E2B(R3) format will be to improve the quality of data collected and support the ability to search and analyze that data to find common trends and issues. This will help regulatory authorities and companies detect and address safety issues with medicines that are for public use.

In preparation for the electronic transmission of premarketing safety reports in the International Council for Harmonisation (ICH) E2B(R3) format, FDA has posted the following documents regarding the electronic submission of Individual Case Safety Reports (ICSRs) for certain investigational new drug application (IND) safety reports for drug and biological products, to FAERS. These documents are posted to help sponsors prepare their systems for the electronic submission of IND safety reports in the E2B(R3) format.

1. Providing Regulatory Submissions in Electronic Format:  IND Safety Reports - Draft Guidance for Industry (October 2019)
2. Electronic Submission of IND Safety Reports - Technical Conformance Guide (April 2022)
3. Technical Specifications Document - FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products (April 2022)
4. FDA E2B(R3) Core and Regional Data Elements and Business Rules (Excel file April 2022)
5. FDA ICSR XML Instances (zip file April 2022)

Pleathate that FDA is currently not accepting the submission of premarket ICSRs in the E2B(R3) format. Please continue to submit investigational new drug application (IND) Safety Reports using eCTD format, and postmarketing reports are still submitted as E2B(R2).

The FDA offers to contact the FAERS electronic submission coordinator at faersesub@fda.hhs.gov in case of any questions related to the update. If you want to learn more about EXTEDO’s E2B(R2) and E2B(R3) compliant Safety Management solution, download the product flyer now.