23. Aggregate reporting – Introduction

Aggregate reporting is the process that reviews the cumulative safety information from a wide range of sources, on a periodic basis and submits the findings to regulators worldwide.

The aggregate safety reports are presented to regulators as soon as the medicine is marketed anywhere in the world and enables understanding of risk and benefit profile of the product over a period of time.

These reports focus not so much on individual cases, but rather on overview, assessment of the safety profile and benefit-risk-evaluation of Adverse Drug Reaction (ADR) and the Serious Adverse Event (SAE) and pregnancy reports. 

Why aggregate reporting is important?

Though the Individual case safety reports were submitted on expedited basis to regulatory authorities, detailed analysis and evaluation of benefit/risk ratio of a drug is not possible at this level. Therefore periodically reviewing safety reports received cumulatively worldwide, becomes highly significant to analyze the benefit/risk balance of the product. 

These reports need special diligence and attention to detail on the one hand, overview and a sense of what is essential on the other hand.

Types of aggregate reports:

Pre-marketing report:

• IND annual reports 
• Clinical study reports (CSR)
• Development Safety Update Report (DSUR)
• Annual safety reports (ASRs) in Europe

Post-marketing report: 

• Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR)
• Periodic Adverse Drug Experience Report (PADER). 
• NDA and ANDA annual reports
• Addendum to clinical overviews (ACO)