24 September 2025
The ICH E2D(R1) Guideline on “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports” has reached Step 4 of the ICH Process on 15 September 2025 and has now entered the implementation phase at Step 5 of the ICH Process.
The E2D(R1) guideline provides recommendations that are harmonised to the extent possible given differences in post-market safety reporting requirements among ICH regions. Where applicable, this guideline notes where regional and local requirements may vary and, as such, marketing authorisation holders (MAHs) should refer to the relevant regional or local regulatory authority’s requirements.
Further information can be found on the E2D(R1) page, including the Guideline and a Step 4 Introductory Training Presentation available for download.