DSUR and PSUR / PBRER

Aggregate Safety Reporting from Development to Post-Marketing

• Importance of pharmacovigilance in patient safety
• Role of DSUR during clinical development
• Role of PSUR/ PBRER in post-marketing surveillance
• Global regulatory frameworks: ICH, EMA, FDA, PMDA
• Signal detection and benefit-risk evaluation
• Submission timelines and regulatory expectations
• Challenges, harmonization, and future considerations

Prior to the introduction of DSUR and PSUR / PBRER frameworks, pharma- ceutical companies encountered challenges due to fragmented regional safety reporting requirements, inconsistent reporting formats, and limited coordination across functions and regulatory regions. The introduction of harmonized ICH and global regulatory requirements established standardized approaches for cumulative safety evaluation, signal detection, benefit–risk assessment, and periodic reporting timelines. Conse- quently, departments such as Pharma- covigilance, Regulatory Affairs, Clinical Operations, Quality, and IT had to adapt their processes through enhanced collaboration, integrated safety systems, stronger compliance oversight, and improved global data management.