Definition

ICH guideline (Step 4 Sept 2025) on post-approval safety data management; harmonizes definitions and handling of post-marketing ICSRs globally.

Example

Unified approach to solicited vs spontaneous and minimum criteria across regions.

Regulatory source

ICH E2D(R1) Step 4 (Sept 2025)

Common mistakes

Continuing to use pre-revision E2D definitions after adoption.

Inspector question

How have you implemented E2D(R1) in your case handling?

Related terms