Aggregate reporting is the periodic review of the cumulative safety information from a number of sources of a drug, submitted to national Competent Authorities.
Such reports are provided to regulators on marketing of the medicinal product and give an understanding and assurance as to the benefit risk profile of the product over a specific period of time.
These periodic reports follow ICH convention and present an overview of the safety profile, benefit-risk-evaluation of Adverse Drug Reactions (ADRs) and the Serious Adverse Events (SAEs) and pregnancy reports.
Since ICSRs need to be reported expeditiously without the ability to evaluate each in the context of overall benefit risk ratio of a drug, the periodic review of all safety reports received cumulatively worldwide is the means to make this assessment of the product.
Aggregate reports are also necessary pre-marketing, for products in development in clinical trials, as well as for products with current marketing authorisation.
