((A-247)) (A-247) Evaluation of Companies Pharmacovigilance Systems:Measuring Performance Before and After Exposure to Saudi regulatory PV Inspection Visits

Background: Pharmacovigilance (PV) is a critical component of pharmaceutical safety involving the continuous monitoring, detection, assessment, and prevention of adverse drug reactions (ADRs) and other drug-related problems post-approval. It ensures that pharmaceutical products remain safe and effective throughout their lifecycle. The Saudi FDA (SFDA) plays a pivotal role in regulating and ensuring compliance with pharmacovigilance practices among all Marketing Authorization Holders in Saudi Arabia. Through stringent inspections, robust regulatory frameworks, Saudi FDA enhances drug safety and protects public health.

Objectives: To conduct a comparative analysis of findings from initial and re-inspection PV visits among Global, Regional, and Local MAHs in Saudi Arabia. This study aims to assess compliance, identify key areas of improvement, and evaluate the impact of inspections on enhancing PV performance over time

Methods: This study analyzes findings from initial and re-inspection PV visits across 13 pharmaceutical companies in Saudi Arabia. It evaluates changes in compliance and performance over time while assessing the impact of SFDA recommendations on the role of the local QPPV. Additionally, the study examines critical, major, and minor findings before and after PV inspections

Results: Our analysis included 292 findings from Initial and Re-Inspection PV visits across Global, Regional, and Local MAHs. Results showed that Global MAHs consistently had more inspection findings compared to Regional and Local MAHs. In the 2023 initial PV inspections, 32 critical, 136 major, and 50 minor findings were identified. However, in re-inspections, these numbers dropped to 15 critical, 31 major, and 28 minor findings, reflecting a 66% overall reduction and significant improvement in compliance and performance. Findings covered areas such as adverse reaction management, signal management, pharmacovigilance system master files, the Qualified Person for Pharmacovigilance, written instructions, and quality management systems, highlighting the impact of SFDA’s regulatory efforts and the need for continuous improvement

Conclusions: This study highlights the significance of PV inspection visits in improving compliance among Marketing Authorization Holders in Saudi Arabia, with a 66% reduction in inspection findings from initial to re-inspection visits. The findings show that Global MAHs initially had the highest number of observations; however, all MAH categories demonstrated measurable progress in addressing PV deficiencies. The reduction in critical, major, and minor findings emphasizes the role of the local health authority in enhancing PV practices, ultimately contributing to public health and safety