Regulatory Focus™ > News Articles > With New Rule in Place, FDA Establishes Procedures for Submitting Vaccine Safety Problems

With New Rule in Place, FDA Establishes Procedures for Submitting Vaccine Safety Problems

Posted 18 July 2014 | By Alexander Gaffney, RAC

With New Rule in Place, FDA Establishes Procedures for Submitting Vaccine Safety Problems

A new draft guidance document issued this week by the US Food and Drug Administration (FDA) establishes best practices for the submission of safety reports related to the use of vaccines.


FDA has since 2009 been advocating for a rule which would require all mandatory postmarketing safety reports to be submitted to the agency in electronic form (instead of paper), saying that the change could allow it to better process, review and archive the documents.

The review component, in particular, could be markedly improved by electronic submissions. A uniform data format would allow FDA to better probe postmarket data for emerging risks, including across similar product classes. Currently, the agency must manually convert submitted paper reports into electronic format—a costly and time-consuming process.

Under a rule proposed in 2009 by FDA, all adverse event reports (such as individual case safety reports, or ICSRs) concerning human drug and biological products—including vaccines—would need to be submitted using FDA's electronic submissions gateway (ESG).

The format would still be based on the International Conference on Harmonisation's (ICH) reporting format, FDA confirmed. And, in rare cases where a reporter can show "good cause," FDA might also grant a waiver to submit a report outside the ESG, it said in the proposed rule.

The rule, Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements, was finalized in June 2014 with only minor changes. The rule becomes effective as of 10 June 2015.

New Guidance

FDA's newest draft guidance document, Providing Submissions in Electronic Format — Postmarketing Safety Reports for Vaccines, is, unlike the rule that precedes it, specifically focused on vaccine products.

The difference is important. Adverse event reports related to biological products are submitted to FDA's Adverse Event Report System, better known by its acronym FAERS. Vaccine products, meanwhile, are submitted to FDA's Vaccine Adverse Event Reporting System, or VAERS.

Both databases utilize the International Conference on Harmonization's (ICH) Individual Case Safety Reporting (ICSR) format to receive reports.

FDA's draft guidance focuses on how companies can submit ICSRs to it under the new rule, and what those ICSRs must contain.

Submissions and Waivers

There are essentially three types of ICSR submissions, FDA says in its guidance: Full ICSRs, ICSR attachments (which include supporting information and documentation), and followup ICSRS (which are meant to "provide a complete picture of the current understanding of an adverse experience").

Those ICSRs (and attachments/followups) can be submitted to FDA electronically in one of two ways: through a database-to-database submission method, or through FDA's eSubmitter web portal. Both are ultimately submitted to FDA through the ESG.

From there, FDA's guidance contains an extensive list of advice. For example, the agency notes that all ICSRs and subsequent reports must bear the same unique case identification numbers to help FDA link initial reports and follow-up information.

Once ICSRs are submitted, FDA's ESG will send out a receipt containing the time and date of the submission, and FDA will send a more complete receipt within 24 hours.

The guidance also addresses waiver requests, which might be used by a company in "rare circumstances," such as in the midst of technical difficulties on the part of FDA or a natural disaster affecting a company. Widespread internet outages might also permit the use of a waiver, FDA postulated, as might a temporary issue with a company's adverse event database. Requests for a waiver should be submitted by mail and include a proposed end date for the waiver. All waivers will be temporary.

Comments on FDA's draft guidance will be accepted until 16 September 2014.


Providing Submissions in Electronic Format — Postmarketing Safety Reports for Vaccines (FR)

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