Regulatory Reform and Digital Transformation of Pharmacovigilance in Uzbekistan: A National Mixed-Methods Analysis of Reporting Patterns, 2023–Mid-2026

Abstract

Background: Pharmacovigilance systems in emerging regulatory settings are increasingly shaped by concurrent legal, institutional, and digital reforms. Evidence on how these reforms affect national reporting patterns remains limited in Central Asia.
Objective: To assess the development of Uzbekistan’s national pharmacovigilance system and changes in safety-reporting patterns between January 2023 and June 2026.
Methods: A retrospective mixed-methods study combined structured analysis of national legislation, regulatory standards, implementation records, and training reports with analysis of aggregated pharmacovigilance data. All 1,500 safety reports recorded during the study period were included. Reporting volume, source, and seriousness were summarised using counts and percentages. Between-period differences were assessed using Pearson’s chi-square test and Cramér’s V. Relative risk was calculated for serious-report proportions in 2025 and the first half of 2026.
Results: The national system received 380 reports in 2023, 295 in 2024, 285 in 2025, and 540 during January–June 2026. Healthcare professionals’ contribution increased from 21.1% in 2023 to 53.7% in the first half of 2026, while that of marketing authorisation holders decreased from 53.7% to 32.6%. Reporter-source composition differed significantly across periods (χ²=120.02; df=6; p<0.001; Cramér’s V=0.20). Serious-report proportions also differed (χ²=87.58; df=3; p<0.001; Cramér’s V=0.24), decreasing from 47.0% in 2025 to 16.7% in the first half of 2026 (RR=0.35; 95% CI: 0.28–0.44). By June 2026, approximately 700 public healthcare institutions had joined the electronic platform, and 1,880 healthcare professionals had received pharmacovigilance training.
Conclusions: Electronic reporting was introduced alongside regulatory reform, institutional registration, and professional training and coincided with expanded direct reporting by healthcare professionals. Because the interventions were concurrent and the 2026 observation covered only six months, the findings indicate temporal association rather than causality. Further evaluation should use equivalent observation periods and case-level indicators of report quality, signal management, and regulatory outcomes.