((A-248)) (A-248) Critical Vs Major finding; According to the classification of MAH in Saudi Arabia

Background: Pharmacovigilance system inspections are designed to review the procedures, systems, personnel, and facilities in place and determine their compliance with regulatory pharmacovigilance obligations. The objective is monitor activities and protect public health by ensuring the continued safety of medicines that authorized in Saudi Arabia.

Objectives: To count and review the inspection findings that documented through inspections visits for local, regional and global MAHs, then to find what are the main characteristics and differences of those findings.

Methods: Data source -Pharmacovigilance inspection database
Data size -80 pharmacovigilance inspections
Study period:between December 2018 to December 2022
Aim :to count and review the inspection findings that documented through inspections visits for local, regional and global MAHs
Eligibility criteria :Registered inspected MAHs (Global, regional and Local)
Statistical analysis: Descriptive analyses

Results: This study analyzed 80 pharmacovigilance inspections of Marketing Authorization Holders (MAHs) in Saudi Arabia, revealing 135 critical and 704 major findings. The most findings were identified in global MAHs (55 critical, 305 major), followed by regional (61 critical, 277 major), and local MAHs (19 critical, 122 major). For global and regional MAHs, the top critical findings were in data collection methods and system oversight, while major findings were most common in assessments of seriousness, causality, and expectedness, and dataset used for signal detection. Local MAHs showed the most critical findings in data collection methods and system oversight, whereas major findings were concentrated in areas such as backup and disaster recovery processes, periodicity of data review, and the audit and corrective and preventive actions process.

Conclusions: This study illustrates that pharmacovigilance inspections revealed a higher number of critical findings in global MAHs and major findings in various areas across different types of MAHs in Saudi Arabia. The prevalent issues across all MAHs included data collection methods and system oversight, indicating areas that require significant improvement to ensure drug safety and compliance with pharmacovigilance regulations