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Submission of Post Marketing Safety
Reports in Electronic Format to FDA
Food and Drug Administration issued a final ruling on June 10, 2014, that requires
Pharmaceutical and Biotech industry to submit post marketing safety reports in an electronic
format. The final ruling and accompanying draft guidance, applies to virtually all post marketing
safety reports for human drug and biologic products, which includes individual case safety
reports (ICSRs) and periodic safety reports PSRs).
The draft guidance provides information related to electronic submission of post marketing
safety reports including individual case safety reports (ICSRs), ICSR attachments and periodic
safety reports for the products - Drug products marketed for human use with approved new
drug applications (NDAs) and abbreviated new drug applications (ANDAs), Prescription drug
products marketed for human use without an approved NDA or ANDA, Biological products,
other than vaccines, marketed for human use with approved biologic license applications (BLAs)
and Nonprescription (over-the-counter or OTC) human drug products marketed without an
approved application. The rule becomes effective September 8, 2015.
(https://www.federalregister.gov)
These new requirements are expected to provide operational efficiency and positive financial
implications. These are expected to improve FDA’s ability to process and archive post marketing
safety reports in a timely manner, make post marketing reports more readily available for
analysis (For example, data from ICSRs submitted electronically are generally available to
reviewers within 2 days of receipt rather than 10-60 days, depending on the type of report) and
will save FDA about $0.8 million $800,000 annually, primarily in the cost of processing paper.
This is also an important step in harmonizing FDA’s post marketing safety reporting regulations
with international standards for electronic submissions. FDA anticipates that this rule will
enhance the industry’s global pharmacovigilance practices by allowing manufacturers to use
common data elements and transmission standards when submitting ICSRs to multiple
regulators.
Information obtained from: https://www.fda.gov