Publication:

Overview of post marketing aggregate reports and global regulatory requirements

Pharmacovigilance is the science that deals with the activities related to the detection, assessment, understanding, and prevention of ADRs. The scope of pharmacovigilance has evolved over time. We now recognize the importance of a systematic approach for monitoring and improving the safe use of medicines. At the level of individual case safety reports, it is not possible for marketing authorization holders (MAH) to evaluate benefit/risk ratio profile and understand the detailed safety feature of a medicinal product. In addition to submission of individual case safety reports MAH also review periodically, cumulative safety information attained from various sources and submit the findings as aggregate reports to drug regulators. Aggregate reporting is a vital tool to study benefit/risk balance of a medicinal product throughout the product’s life cycle. The timelines, frequency and exact type of aggregate report required to be submitted for the approved product varies globally amongst various drug regulatory agencies. In this review the significance, background, objectives, scope, structural components, timelines for regulatory submissions of post marketing aggregate reports viz. PSUR, PBRER, and PADER have been discussed.