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FDA Issues Final Rule on Submitting Adverse Event Reports Using Mandatory Electronic Format

Posted 09 June 2014 | By Alexander Gaffney, RAC

FDA Issues Final Rule on Submitting Adverse Event Reports Using Mandatory Electronic Format

The US Food and Drug Administration (FDA) has adopted a final rule that will soon change the way the agency accepts postmarket safety reports for drugs and biological products, requiring their submission in electronic format.

Background

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 prove 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 the 2009 proposed rule, all adverse event reports (such as individual case safety reports, or ICSRs) concerning human drug and biological products, including vaccines and generic drugs, 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.

Rule: Details and Changes

FDA said that despite making several minor changes to further clarify the rule, it has left its final rule "largely unchanged" from the one it first proposed in 2009.

The rule, Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements, would for example add nonprescription drugs marketed without an approved application to report all side effects to FDA using electronic reporting forms. The requirements do not apply to OTC products approved by FDA under Section 505 of the Federal Food, Drug and Cosmetic Act, however.

The final rule also includes several new provisions intended to clarify how to protect patient privacy, such as by substituting names for codes. "We recommend that no identifying information, such as initials or birthday, be used as part of the patient identification code," FDA writes.

That requirement will not be in effect for vaccine products, however.

The rule also does not affect investigational new drugs, safety update reports, annual reports, biological product deviation reports, blood transfusion complication reports, human cell or tissue reports or NDA field alert reports, FDA confirmed.

Reports will be able to be submitted through the safety reporting portal (SRP) at www.SafetyReporting.hhs.gov .

The requirements go into effect on 10 June 2015.

 

Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements


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