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GUIDANCE DOCUMENT

FDA Regional Implementation Specifications for ICH E2B(R3) Implementation February 2014

Download the Final Guidance Document
Final
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Drug Evaluation and Research

This technical specifications document is to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachments) 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 Agency). This document describes FDA’s technical approach for submitting ICSRs, for incorporating its regionally controlled terminology,1 and for adding FDA Adverse Event Reporting System (FAERS) regional data elements that are not addressed in the International Conference on Harmonisation’s (ICH) E2B (R3) Implementation Guideline (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 marketed without an approved application)
  • Biological products marketed for human use with approved biologic license applications (BLAs).

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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 comments should be identified with the title of the guidance.