In this episode, we explain one of the most important guideline updates of the decade: the revision and implementation of ICH E2D(R1) on post-approval safety data management.

The original guideline from 2003 could no longer keep up with the rise of digital platforms, patient support programs, market research programs, and the massive increase in safety data.

E2D(R1) changes that. It introduces modern definitions, clearer responsibilities for MAHs, and a new foundation for structured safety data activities through the Organised Data Collection System (ODCS).

We also look at how the guideline aligns with E2B(R3), including the three new study-type values for coding cases from PSPs, MRPs, and digital platform activities.

You’ll learn:
• why this revision was needed
• how new data sources are classified
• what ODCS really means in practice
• how to distinguish spontaneous vs. solicited reports
• what changes MAHs should expect in E2B(R3) reporting

If you work in drug safety, regulatory intelligence, or PV operations, this episode gives you the clarity you need to prepare for the 2026 implementation.

Link to ICH E2D(R1) guideline: https://database.ich.org/sites/default/files/ICH_E2D%28R1%29_Step4_FinalGuideline_2025_0819.pdf