ICH Draft Guide on Post-Approval Safety Data

FDA has published a draft of the International Council for Harmonization E2D(R1) guideline Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Report, that has been released for comments. The document provides guidance on definitions and standards for post-approval individual case safety reporting.

“The guideline provides recommendations that are harmonized to the extent possible given differences in post-market safety reporting requirements among ICH regions,” it says. “Where applicable, the guideline notes where local and regional requirements may vary and, as such, marketing authorization holders should refer to the relevant local or regional regulatory authority’s requirements.”

The guideline includes an Introduction, Definitions and Terminology, Types of Individual Case Study Reports, Sources of Individual Case Study Reports, Standards for Reporting, and Good Case Management Practices.