Electronic Submission of Postmarketing Safety Reports Involving Vaccine Products; Notice of Pilot Project

摘要

The Center for Biologics Evaluation and Research (CBER) in the Food and Drug Administration (FDA) is announcing a pilot project to evaluate its current systems for receiving postmarketing safety reports involving vaccine products electronically for processing into the Vaccine Adverse Event Reporting System (VAERS). As part of this pilot project, CBER also plans to assess the updated International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E2B(R3) specification for electronic transmission of vaccine Individual Case Safety Reports (ICSRs). Participation in the pilot project is open to firms that submit postmarketing reports into VAERS. CBER plans to accept participation from up to six applicants. The pilot project is intended to provide industry and CBER regulatory review staff with an opportunity to evaluate current system capabilities for sending and receiving postmarketing safety reports for vaccine products using FDA's Electronic Submissions Gateway (ESG), including the use of the updated ICH E2B(R3) specification.