On Friday, April 29th, FDA’s Center for Biologics Evaluation and Research (CBER) announced the availability of a new program supporting the submission of vaccine adverse event information. The system, Vaccine Adverse Events Reporting System (VAERS) eSubmitter program, is a free software program that allows for “the electronic submission of postmarketing individual case safety reports (ICSRs) and ICSR attachments of adverse events for human vaccine products.”
In its Federal Register announcement, CBER stated that the software is for voluntary use and is intended to assist users with the submission of adverse events to FDA by ensuring the submission contains the minimum regulatory requirements for the Agency to conduct a comprehensive review. CBER also noted that “the VAERS eSubmitter program will help to improve the consistency, quality, and completeness of ICSR submissions and make the submission and review process more user-friendly for those required to report postmarketing adverse events for human vaccine products.”
On June 10, 2014, CBER published a final rule entitled “Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements.” The final rule took effect on June 10, 2015, and stated that applicants must submit all postmarketing ICSRs and ICSR attachments to CBER in electronic format. As stated in the final rule, as well as in CBER’s August 2015 final guidance entitled “Providing Submissions in Electronic Format—Postmarketing Safety Reports for Vaccines,” the Agency is providing two options for the submission of ICSRs and ICSR attachments in electronic format. The options include:
It is recent announcement, FDA stated that applicants can choose either of the options listed above when electronically submitting ICSRs and ICSR attachments to VAERS.
“The ICSR eSubmitter software is a government-issued software provided in support of the Government Paperwork Elimination Act of 1998 (44 U.S.C. 3504). As users of the eSubmitter software, applicants and others required to report postmarketing adverse events are not required to perform their own file validation process.”
Additional information regarding the regulatory requirements for the preparation and submission of ICSRs and ICSR attachments can be found on CBER’s eSubmitter web page.
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