ICH E2D(R1) Guideline on Post-Approval Safety Data Enters Implementation Phase

The revised ICH E2D(R1) Guideline, Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports, has reached Step 4 and entered the implementation phase at Step 5 of the ICH process. This update provides enhanced guidance on definitions, standards, and good case management practices for post-approval safety reporting. It recognises variations in regional and local regulatory requirements, urging marketing authorisation holders to comply accordingly. Since its initial release, new sources of safety information have emerged, including digital platforms, social media, mobile health technologies, market research, patient support programmes, non-interventional studies, and literature. The revised guideline addresses these evolving data sources and introduces new recommendations for managing safety data from non-interventional studies involving both primary and secondary data. The European Medicines Agency (EMA) will implement the guideline within the EU legal framework from 18 March 2026.

07-11-2025