2023-03372: Electronic Submission of Adverse Event Reports to the Food and Drug Administration Adverse Event Reporting System Using International Council of Harmonisation E2B(R3) Standards; Public Meeting; Request for Comments

Summary

The Food and Drug Administration (FDA, the Agency, or we) is announcing a series of two public meetings entitled "Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) Using International Council for Harmonisation (ICH) E2B(R3) Standards." The purpose of these public meetings is to provide the pharmaceutical industry and other interested parties with updated information on the plans, progress, and technical specifications to upgrade electronic submission standards for drug, biological product, and drug- or biologic-led combination products in the premarket and postmarket safety surveillance programs managed by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). These meetings are part of a public meeting series initiated by FDA in 2019 to communicate FDA's implementation plan and regional requirements for ICH E2B(R3). The 2023 meetings will focus on enhancements to electronic submission of Individual Case Safety Reports (ICSRs) in FAERS using ICH E2B(R3) standards. FDA is seeking input from stakeholders as it fulfills its commitment to implement ICH E2B(R3) and will use the information provided by the public to inform the enhancements to FAERS required for the implementation of ICH E2B(R3) standards and relevant regional variations.

The agency’s own summary, as published.