What Is a DSUR in Pharmacovigilance?

The DSUR in Pharmacovigilance is Development Safety Update Report (DSUR) is an annual safety report required for investigational products under clinical development. It provides regulators with a global, integrated safety evaluation of a drug, allowing FDA, EMA, and other authorities to assess ongoing benefit–risk.

Unlike periodic post-marketing reports, DSURs focus on development-phase risk management, making them a critical inspection touchpoint.

– DSUR in Pharmacovigilance Regulatory Framework: FDA, EMA and ICH E2F

DSUR requirements are harmonized under ICH E2F, but expectations vary:

• FDA: DSUR submitted as IND Annual Report (with US-specific expectations)

• EMA: DSUR submitted via EU clinical trial systems

• ICH E2F: Defines structure, content, and analysis standards

Regulators expect consistency across regions, not copy-paste submissions.

– Core DSUR Sections (ICH E2F Aligned)

• Exposure data (subjects, dosing, duration)

• Cumulative safety findings

• Serious adverse reactions

• Signal evaluation

• Risk mitigation actions

• Overall benefit–risk assessment

Inspection findings often arise from weak cumulative analysis, not missing sections.

– Common DSUR Inspection Findings

• Inconsistent safety data vs ICSR database

• Missing signal evaluation rationale

• Poor alignment with IB or protocol amendments

• Lack of documented medical review

– Why DSURs Fail Inspections

DSURs fail when treated as administrative submissions instead of strategic safety documents.

At GPLACO SOLUTIONS, DSURs are built as inspection-ready narratives, aligned with signal management, ICSRs, and risk management activities.

 – How GPLACO SOLUTIONS Supports DSUR Compliance for the US & EU?

• ICH E2F compliant DSUR authoring

• Cross-functional data reconciliation

• Inspection-focused gap analysis

• FDA & EMA submission support

Proven across 150+ products with zero critical DSUR findings. 

Connect with us for a consultation – Contactus@globalplacosolutions.com