ICH Topic E2F Development Safety Update Report

This ICH harmonised tripartite guideline defines the Development Safety Update Report (DSUR) as a single annual report providing a comprehensive review of safety information for investigational drugs and biologicals, whether or not they have marketing approval. It harmonises the content, format and timing of periodic clinical safety reporting so regulators receive a consistent overview of evolving safety profiles and development status, instead of multiple region‑specific reports. The guideline also explains how the DSUR relates to the Periodic Safety Update Report, highlighting areas of overlap but emphasising their different focus and recipients.

It sets clear expectations for the minimum DSUR content, including report numbering, submission within 60 calendar days of the data lock point, use of blinded and unblinded data, and integration of safety information across indications, dosage forms, strengths and populations. The document outlines general principles such as preparing a single DSUR per active substance, using the Development International Birth Date to define periodicity and data lock point, and selecting appropriate reference safety information, usually the Investigator’s Brochure. A recommended structure with 20 core sections covers marketing approval status, actions taken for safety reasons, trial inventories, cumulative exposure, serious adverse reaction line listings, serious adverse event tabulations, key safety findings from trials and other studies, lack of efficacy impacting safety, region‑specific information, an overall safety assessment, benefit‑risk considerations, important risks and conclusions. Appendices provide a glossary of terms, example tables for clinical trial listings, exposure summaries, line listings and serious adverse event tabulations, plus narrative and tabular examples of the Summary of Important Risks to support safety reporting and risk management planning.