EU Creates Time-Indexed Drug Adverse-Event Dataset
Researchers submit a time-indexed reference dataset for EU drug adverse events on 27 Mar 2026, extracting Section 4.8 from SmPCs of 1,513 centrally authorized products (data lock 15 Dec 2025) to assemble 17,763 SmPC versions and 125,026 drug–AE associations covering 1995–2025. A restricted dataset includes 1,479 active products and 110,823 associations (74.5% pre-marketing), enabling rigorous evaluation of signal-detection methods.
Scoring Rationale
Provides a novel, industry-scale time-indexed EU SmPC dataset with broad scope and direct usability for signal-detection benchmarking. Score is high for novelty, scope, and actionability but slightly reduced because this is a preprint/single-source submission rather than a peer-reviewed or official regulatory release.
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Sources
- Read Original[2603.26544] Development of a European Union Time-Indexed Reference Dataset for Assessing the Performance of Signal Detection Methods in Pharmacovigilance using a Large Language Modelarxiv.org
