What is Aggregate Reporting?
Aggregate reporting is a systematic approach to monitoring and evaluating a drug's safety profile and benefit-risk ratio after reaching the market. It involves collecting and submitting safety information on adverse drug reactions (ADRs) to regulatory authorities.
Types of Aggregate Reports
There are various types of aggregate reports, depending on the market stage of the product. Some of the common ones are Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Periodic Safety Update Reports (PSUR), and Periodic Adverse Drug Experience Report (PADER). In addition, different regulatory agencies have additional requirements for aggregate reports.
PADER
PADERs are quarterly reports submitted to the US FDA for the first three years after product approval and annually. They contain information on severe cases and events of particular interest, following the 21 CFR regulation 314.80.
PBRER
PBRERs are detailed reports submitted to regulatory agencies every 6 months for the first two years and then annually. They include information on drug exposure, regulatory updates, clinical trials, and benefit-risk assessment analysis.
PSUR
PSURs are similar to PBRERs but are less detailed. They are submitted to specific regulatory agencies and include information on case descriptions and regulatory updates.
Challenges in Aggregate Reporting
There are several challenges in aggregate reporting, such as:
Maintaining regulatory compliance
Iidentifying and using the right resources
Tracking the report from authoring to submission
Handling large volumes of data
Adapting to ever-changing regulations
Aggregate Reporting Solutions by DDReg
DDReg's medical and safety team has extensive experience preparing aggregate reports for regulatory agencies in over 130 countries. They use in-house tools to track and manage reports, ensuring compliance with the latest regulations and submission timelines. DDReg's aggregate report capabilities include line listings, medical review, submission to authorities, and handling agency queries.