REGULATORY REQUIREMENTS FOR ELECTRONIC SUBMISSION OF BA/BE ADVERSE EVENT REPORTS TO FAERS (FDA ADVERSE EVENTS REPORTING SYSTEM)

Safety reports are crucial for various reasons, including death, life-threatening adverse events, inpatient hospitalization, and birth defects.In the US, the FDA regulates safety reports through regulations like 21 CFR 312.32,21 CFR 314.80, and 21 CFR 803.21The E2B(R3) standard, which is supported by the International Council for Harmonization (ICH), is currently the accepted format for electronic submission of post-marketing individual case safety reports (ICSRs) to the FDA.These submissions can be either expedited or non-expedited and include biological products regulated by CDER.On June 10, 2014, the FDA published a final regulation mandating that the industry file post-marketing safety reports electronically.There are two types of electronically submitted safety reports: mandatory safety reports and voluntary safety reports.The FDA has launched a new website for submitting safety reports for premarket and postmarked submissions.The FDA requires applicants for human drugs and biological products, as well as accountable personnel at businesses that have reporting duties, to adhere to certain guidelines to submit post-marketing ICSRs and attachments electronically via the Safety Reporting Portal (SRP).PSR submissions include During the reporting period, nonexpedited ICSRs as well as a descriptive section were received.