From fragmented reporting to real-time foresight: What the FDA’s AEMS means for pharmacovigilance

The launch of the U.S. Food and Drug Administration’s (FDA) Adverse Event Monitoring System (AEMS)1 marks what is likely to be one of the most significant structural shifts in pharmacovigilance in recent years. For decades, adverse event reporting across FDA-regulated products operated within a fragmented architecture, with multiple databases each aligned to specific product categories, evolving independently and often lacking interoperability. That model is now giving way to a unified, real-time system that fundamentally changes how safety data is generated, accessed and acted upon.