DSUR and PSUR / PBRER am 04.12.2026

Aggregate Safety Reporting from Development to Post-Marketing

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.