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GUIDANCE DOCUMENT

FDA Regional Implementation Specifications for ICH E2B(R3) Reporting to the FDA Adverse Event Reporting System (FAERS) June 2016

Final
Docket Number:
FDA-2016-D-1280
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The technical specifications document is to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachements) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) in the Food and Drug Administration (FDA or Agengy). This document describes FDA's technicalapproach for submitting ICSRs, for incorporating its regionally controlled terminology,1 and for adding FDA Adverse Event Reporting Systems (FAERS) regional data elements that are not addressed in the International Conference on Harmonisation's (ICH) E2B (R3) Implementation Guidleine (IG) for the following FDA-regulated 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 application
  • Nonprescription (over-the-counter human drug products with marketed without an approved application)
  • Biological products marketed for human use with approved biologic license applications (BLAs).

This document does not apply to prophylactic vaccines; whole blood, or components of whole blood; and human cellar and tissue-based products regulated under section 361 of the Public Health Service Act or Investigational New Drug Safety Reports.2

ICSRs (and any ICSR attachments) should be prepared in accordance with the ICH E2B (R3) data elements, in extensible markup language (XML)3 file format and submitted through FDA's "Electronic Submissions Gateway" (ESG). ICSRs should not be submitted to the electronic Common Technical Document (eCTD). Agency information about electronic submissions will be updated as necessary to reflect the evolving nature of the technology and the experiences of those using this technology.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2016-D-1280.

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