Regulatory expectations for drug safety have evolved faster in the past five years than in the previous two decades combined. The US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other global authorities now expect comprehensive, reliable and transparent data in safety reports. Recent FDA rejections demonstrate the high level of these standards. Even powerful therapies can be delayed or rejected because of gaps in trial design, inconsistencies in safety documents, or unresolved risks. These shortcomings prevent regulators from seeing the full picture of safety. The new safety mandate supports AI-ready pharmacovigilance.[1][2]