On June 10, 2014, FDA published a final rule in the Federal Register, titled "Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements." Among many things, this rule states that "certain postmarketing safety reports… be submitted to FDA in an electronic format that the Agency can process, review, and archive." The rule and the many requirements within, will go into effect in just a few short weeks on September 8, 2015, giving vaccine makers more than a year to comply after the announcement was made.
With the new rule in place, the Agency announced a draft guidance, titled "Providing Submissions in Electronic Format—Postmarketing Safety Reports for Vaccines," on July 18, 2014.
Last week, FDA announced the availability of the final guidance ("Providing Submissions in Electronic Format—Postmarketing Safety Reports for Vaccines") regarding making postmarket regulatory submissions to CBER in electronic format. The guidance is one in a series of documents, and is intended to establish a set of procedures and best practices for submitting vaccine safety reports.
So, what is the difference between this guidance and the rule that will go into effect in just two weeks? The major difference is that the guidance is focused solely on vaccine products, and the rule applies to postmarket safety reports for both drugs & biological products.
Intended to assist applicants, the guidance includes information and recommendations regarding the e-submission of Individual Case Safety Reports (ICSRs) and attachments to ICSRs into the Vaccine Adverse Event Reporting System (VAERS). In addition, it applies only to vaccines marketed with approved BLAs that are regulated by CBER.
The guidance, which defines ICSR as "a description of an adverse experience related to an individual patient or subject that is associated with the use of a vaccine product," goes on to state that there are three types of ICSR submissions, including:
- Full ICSRs,
- ISCR attachments, and
- Follow-up ICSRs.
The guidance provides the following "general information related to electronic submission":
- There are two parts to an ICSR submission (initial or follow-up): (1) the ICSR itself and (2) the ISCR attachments.
- ICSRs and ICSR attachments can be submitted into VAERS one of two ways: (1) via a database-to-database submission method or (2) through FDA’s eSubmitter tool. Both options involve XML files and are ultimately submitted to FDA through the Electronic Submissions Gateway (ESG).
- ICSRs and ICSR attachments must be submitted electronically, so CBER will provide technical specification documents that will provide more information on how to create and submit the documents in a compliant way.
- Unique case identification numbers must be the same in the initial report and any follow-up report(s).
- Submissions must be sent to FDA through their ESG, which is available 24/7. In addition, ICSR attachments should be submitted at the same time as the associated ICSR file is submitted. Otherwise, it should be made as an attachment to a follow-up report.
- Once the submission is received by the ESG, a message will be sent to the applicant. The date of the message will serve as FDA’s official receipt date. It is expected that the submission will be received and the sender will be notified of such receipt within 24 hours.
- If you do not receive acknowledgement of receipt within 24 hours, you should first check the FDA ESG web page to ensure there are no problems with the ESG.
- If functional, contact ESGHelpDesk@fda.hhs.gov for assistance (only if you have not received confirmation of receipt after 24 hours).
- If it is not functional for more than 24 hours, FDA will post a notice online regarding alternative methods for submission.
In addition, the guidance also includes information regarding requests to temporarily waive the requirement that the safety report be submitted electronically. These waiver requests will only be needed in rare circumstances, which FDA states as "acts of nature, widespread internet outages, temporary issues with the applicant’s adverse event database(s)", etc. and will not be grated to companies experiencing technical difficulties submitting their application of their electronically. (For more information, view the full guidance here.)
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