FDA issued a final rule on June 10, 2014, that requires industry to submit postmarketing safety reports in an electronic format. The final rule and accompanying draft guidance, Providing Submissions in Electronic Format—Postmarketing Safety Reports, applies to virtually all postmarketing safety reports for human drug and biologic products, which includes individual case safety reports (ICSRs) and periodic safety reports.

These new requirements are expected to improve FDA’s ability to process and archive postmarketing safety reports in a timely manner, and make postmarketing reports more readily available for analysis.

These requirements will save FDA about $0.8 million annually, primarily in the cost of processing paper.

Unlike paper submissions, electronically submitted reports are available for analysis as soon as they have been processed by FDA. For example, data from ICSRs submitted electronically are generally available to reviewers within two days of receipt rather than 10-60 days, depending on the type of report.

The final rule is also an important step in harmonizing FDA’s postmarketing safety reporting regulations with international standards for submitting safety information electronically. FDA anticipates the final rule will enhance industry’s global pharmacovigilance practices by allowing manufacturers to use common data elements and transmission standards when submitting ICSRs to multiple regulators.

FDA published the proposed rule in August 2009. The Agency received comments from a total of seven commenters, who generally supported the proposal and agreed that requiring electronic submission of postmarketing safety reports would enhance public health and safety.

The final rule issued with a draft guidance for industry. The rule becomes effective June 10, 2015.


Posted on the FDA website on 10 June 2014