(010) Comprehensive Analysis of Pharmacovigilance Inspections Practices: Focus on QPPV Responsibilities in the Pharmaceutical Industry in Saudi Arabia

Background: Pharmacovigilance is a critical component of pharmaceutical safety, it involves monitoring and assessing the safety of pharmaceutical products post-approval. The Saudi Food and Drug Authority (SFDA) regulates and ensures compliance with pharmacovigilance practices among Marketing Authorization Holders (MAHs) in Saudi Arabia.

Objectives: This study aimed to comprehensively analyze inspection findings among North American and European MAHs, Gulf and North African MAHs, and Saudi Arabian MAHs and highlight areas of concern within the inspection topics of MAHs in Saudi Arabia.

Methods: A descriptive secondary data analysis was performed to examine inspection reports from the SFDA between January 2019 and December 2022. All MAHs submitted to regulatory inspections by the SFDA were included. The MAHs were categorized into three groups according to their countries of origin: North American and European MAHs, Gulf and North African MAHs, and Saudi Arabian MAHs.

Results: The study analyzed 1122 inspection findings from 2019 to 2022, categorized based on severity and MAH type. North American MAHs had the highest number of findings [498, (46.7%)], with Major findings being the highest proportion in all [704, (62.7%)] MAH types. Additionally, management and signal management consistently emerged as a top inspection topic.

Conclusions: The analysis of MAHs and their inspection findings between 2019 and 2022 has revealed that North American and European MAHs consistently reported higher inspection findings than Gulf and North African and Saudi Arabian MAHs. More inspection findings in Gulf and North African MAHs than in Saudi Arabian MAHs highlight the impact of regional guidelines, regulatory interpretations, resource constraints, and communication challenges on inspection outcomes. The lack of harmonization in pharmacovigilance systems between Saudi Arabia and neighboring countries further might contributed to major findings, emphasizing the need for alignment with global pharmacovigilance standards. Moreover, areas for improvement were identified, such as management and reporting adverse reactions