E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports

5th March 2026

Summary:
This draft guidance updates the original ICH E2D guideline from 2003 and provides revised definitions and standards for the management and reporting of Individual Case Safety Reports (ICSRs) after a medicine has been authorised. The aim is to improve the quality and consistency of post-marketing safety information and to harmonise how adverse event data are collected and reported across regulatory regions.

The revision clarifies terminology related to adverse events and adverse drug reactions and expands guidance on the types and sources of safety reports. It also reflects the increasing use of new data sources, such as digital platforms, patient support programmes and market research programmes, which may generate safety information relevant to pharmacovigilance activities.

In addition, the guidance sets out expectations for identifying and managing ICSRs, including reporting criteria, case evaluation, follow-up procedures and good case management practices. These updates are intended to support more effective monitoring of medicine safety throughout the post-approval phase of the product life cycle.

Link:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e2dr1-post-approval-safety-data-definitions-and-standards-management-and-reporting-individual-case

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