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# Post-Approval Safety Data Reporting Guide
- URL: https://www.fdaweb.com/post-approval-safety-data-reporting-guide/
- Published: 2024-03-13T12:00:00.000Z
- Updated: 2026-09-14T14:25:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156538

FDA has published an International Council for Harmonization (ICH) draft guidance, *E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports*, with guidance on definitions and standards for post-approval individual case safety reporting and good case management practices. The [document](https://www.fda.gov/media/176977/download?ref=fdaweb.com) says it provides recommendations that are harmonized to the extent possible given differences in post-marketing safety reporting requirements among the ICH regions.

The guidance contains an Introduction, Definitions and Terminology, Types of Individual Case Safety Reports, Sources of Individual Case Safety Reports, Standards for Reporting, and Good Case Management Practices.