Posted 22 June 2016
By Zachary Brennan
The US Food and Drug Administration (FDA) on Wednesday released the technical specifications to assist interested parties in electronically submitting individual case safety reports (ICSRs) and ICSR attachments to its Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
The 19-page specifications document describes FDA’s technical approach for submitting ICSRs, for incorporating regional terminology, and for adding the FDA Adverse Event Reporting System (FAERS) regional data elements that are not addressed in the International Council on Harmonisation’s (ICH) E2B (R3) Implementation Guideline (IG) for brand name and generic drugs, over-the-counter drugs and biologics. The document does not apply to vaccines; whole blood, or components of whole blood; and human cellular and tissue-based products.
“Regional data elements are considered non-harmonized; however, the ICH [extensible markup language] XML file structure allows regions to use regionally controlled terminology and to add region-specific elements as specified in this document,” FDA says. “In addition to the regional specifications described in this document, FDA supports use of all the ICH E2B(R3) data elements and recommends that stakeholders refer to other relevant technical documents to help create compliant ICSR files.”
ICSRs and any attachments should be prepared in accordance with the ICH E2B(R3) data elements, FDA said, in XML file format and submitted through the “Electronic Submissions Gateway,” rather than as an electronic Common Technical Document (eCTD).
FDA Regional Implementation Specifications for ICH E2B(R3) Implementation Postmarket Submission of Individual Case Safety Reports for Drugs and Biologics, Excluding Vaccines