Electronic Submission of Postmarket Safety Reports
The FDA provided updated instructions and guidance for the electronic submission of post-market Individual Case Safety Reports (ICSRs) for human drugs and biological products.
This applies to manufacturers, distributors, packers, and other parties involved in human drugs and biologics who are subject to mandatory safety reporting requirements.
The focus on electronic submission protocols suggests a continued agency emphasis on data standardization and the streamlining of safety signal intake. Regulatory and IT departments may need to ensure their electronic submission gateways are correctly configured to meet these specific instructional requirements. Failure to adhere to these reporting instructions could lead to procedural non-compliance during post-market surveillance audits.
Verify that internal pharmacovigilance systems and workflows align with current electronic ICSR submission protocols to maintain compliance with mandatory reporting requirements. Ensure that distribution and packing partners are aware of their specific reporting responsibilities. Review technical specifications for electronic data interchange (EDI) to prevent submission failures.
This page provides human drug and biological product manufacturers, distributors, packers, and other parties subject to mandatory reporting requirements with the instructions on how to electronically submit postmarket Individual Case Safety Reports (ICSRs) to the FDA.
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