Development Safety Update Report(DSUR)
An annual comprehensive safety report submitted by sponsors of investigational drugs to regulatory authorities summarizing the safety profile during the reporting period.
Usage Examples
- The DSUR consolidated safety data from 12 active trials across 8 countries for the reporting year.
- A new safety signal identified in the DSUR triggered an Investigator's Brochure update.
- DSUR submission timing aligns with the Development International Birth Date anniversary.
What is DSUR?
A Development Safety Update Report (DSUR) is the annual safety report required for investigational drugs in clinical development, harmonized across regulatory authorities under ICH E2F. The DSUR consolidates safety information accumulated over the reporting period across all clinical trials and studies involving the investigational product, regardless of jurisdiction or indication.
The DSUR is prepared on a Development International Birth Date (DIBD) anniversary and submitted to regulators with which the sponsor has an active IND or CTA. It replaces prior disparate annual reports (US IND Annual Report, EU Annual Safety Report) with a single harmonized document. Content includes cumulative and interval exposure, serious unexpected suspected adverse reactions (SUSARs), safety signals evaluated, risk-benefit considerations, and updates to the Investigator's Brochure.
DSURs complement but do not replace expedited safety reporting (SUSAR reports, 7-day and 15-day reports) — those remain on their own timelines. The DSUR is the periodic look-back and forward-looking safety communication; expedited reports handle individual significant events as they occur.
Regulatory Context
This term appears most often in pharmacovigilance workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside ICH E2F, 21 CFR 312, EU CTR 536 2014.
When This Matters
- The DSUR consolidated safety data from 12 active trials across 8 countries for the reporting year.
- A new safety signal identified in the DSUR triggered an Investigator's Brochure update.
- DSUR submission timing aligns with the Development International Birth Date anniversary.
Common Mistakes
- Treating safety signal reviews as periodic instead of continuous.
- Not linking new enforcement letters to internal CAPA and labeling workflows.
- Using static templates for dynamic benefit-risk communication updates.
Related Regulations
Frequently Asked Questions
A DSUR covers investigational (pre-market) safety during clinical development. A PSUR or PBRER covers post-marketing safety for approved products. The DSUR focuses on trial data and evolving risk-benefit for ongoing development; the PSUR/PBRER focuses on cumulative real-world safety experience for marketed products.
A DSUR is required annually for any investigational medicinal product with active clinical studies under regulatory oversight in ICH regions. The first DSUR is submitted approximately one year after the Development International Birth Date (first regulatory authorization to conduct clinical trials in any country).
Yes, in practice. FDA accepts a DSUR in lieu of a separate IND Annual Report under 21 CFR 312.33. Sponsors using the DSUR must still meet the IND-specific content requirements, which FDA guidance maps to DSUR sections.
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Sources & References
