ICH E2D(R1) Guideline on Safety Data Management reaches Step 4

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 and has now entered the implementation phase at Step 5 of the ICH Process.

Background & Updates

The E2D guideline provides guidance on definitions and standards for post-approval individual case safety reporting, as well as good case management practices. Where applicable, the 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.

Since its original publication new sources of post-approval safety information have emerged or are more frequently used (e.g. digital platforms, social media, mobile health technologies, market research programs, patient support programs, non-interventional studies, literature), which vary in characteristics and contributions to the quality of the safety data received. The revised Guideline ICH E2D(R1) thus provides updates on the definitions, standards, and regulatory guidance for the management and reporting of post-approval drug safety information. It aims to support appropriate safety surveillance of medicinal products based on the current practices and needs. New guidance is also included focusing on the management of safety data from non-interventional studies with primary data collection, as well as from non-interventional studies with secondary use of data.

The European Medicines Agency (EMA) has now published the guideline, which will be applied within the European legal framework starting 18 March 2026. Further information can be found on the ICH E2D(R1) page, including the Guideline and a Step 4 Introductory Training Presentation available for download, and on the EMA website.