ICH E2D Post-approval Safety Data Management Guideline Effective March 2026
The revised ICH E2D(R1) guideline provides updates on the definitions, standards, and regulatory guidance for the management and reporting of post-approval drug safety information with the aim 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. Where applicable, the guideline notes where local and regional requirements may vary and, as such, marketing authorization holders should refer to the relevant regional and local regulatory authority’s requirements.
The ICH E2D guideline will take effect in the European Union on March 18, 2026.
This guideline impacts post-approval safety obligations, including sources of individual case safety reports (ICSRs), types of ICSRs, reporting standards, and good case management practices.
Document Reference
ICH E2D post-approval safety data management - scientific guideline