FDA: Sentinel System annual report

The FDA published the Sentinel System's annual report for fiscal year 2025, demonstrating continued expansion of the distributed data network. The system now covers approximately 127 million active patients through its data partner network, an increase from 118 million in the prior year. The report details 23 completed active surveillance assessments during the fiscal year, including protocol-based evaluations of COVID-19 therapeutics, GLP-1 receptor agonists, and gene therapy products.

What this means for practice: The Sentinel System's expanding coverage means that regulatory agencies can detect and evaluate safety signals with increasing statistical power and speed. Industry pharmacovigilance teams should consider how their own signal detection programs compare to regulatory capabilities.

EMA: Darwin EU pilot study

The European Medicines Agency launched a federated pilot study through its Data Analysis and Real World Interrogation Network (Darwin EU) examining the incidence of euglycemic diabetic ketoacidosis associated with SGLT2 inhibitors across six European healthcare databases. The study uses a common data model to enable distributed analysis without transferring patient-level data.

The pilot represents a practical implementation of the federated pharmacovigilance model that has been theoretically discussed for years. By bringing analysis to data rather than data to analysis, Darwin EU addresses the privacy, governance, and interoperability challenges that have historically limited multi-database safety studies in Europe.

Japan PMDA: CIOMS form update

The Japanese Pharmaceuticals and Medical Devices Agency announced updated requirements for the CIOMS I individual case safety report form, adding new fields for genomic and biomarker safety data. The update reflects the PMDA's position that as pharmacogenomic data increasingly informs drug development, adverse event reporting should capture relevant genetic and biomarker information when available.