FDA Publishes ICH Postapproval Safety Data Guide

FDA has published the International Council for Harmonization (ICH) E2D(R1) guidance, Postapproval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports. The document says it is important to establish an internationally standardized procedure to ensure the quality of postapproval safety information and to harmonize, when feasible, the way of gathering and reporting information.

It says this ICH guidance provides guidance on definitions and standards for postapproval individual case safety reporting, as well as good case management practices. The guidance provides recommendations that are harmonized to the extent possible, given differences in postmarket safety reporting requirements among ICH regions, it says.

The document includes an Introduction, Definitions and Terminology, Types of Individual Case Safety Reports (ICSRs), Sources of ICSRs, Standards for Reporting, and Good Case Management Practices.