Key Findings from Pharmacovigilance Inspections in Saudi Arabia's Pharmaceutical Sector.

backgroundPharmacovigilance 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.

objectiveThis study aimed to comprehensively analyze inspection findings among International, Regional, and Local MAHs and highlight areas of concern regarding the inspection topics of MAHs in Saudi Arabia.

methodsA descriptive secondary data analysis of SFDA inspection reports was conducted from January 1st, 2019, to December 2022 31st. All MAHs subject to regulatory inspections by the SFDA were included, focusing on initial routine inspections conducted as part of the MAH's first regulatory review. A total of 80 inspection visits were analyzed. MAHs were categorized based on their countries of origin: International, Regional, and Local MAH.

resultsThe study identified 1,122 inspection findings from 2019 to 2022, categorized by significance and MAH type. The results indicated a strong dominance of international MAHs in the market, accounting for 60% of the total distribution. International MAHs were primarily classified as major [704, (62.7%)] findings. A decreasing trend in the findings was observed from 2020 to 2022. International MAHs consistently reported most major findings, peaking in 2021, whereas regional MAHs showed variability with a notable decrease in major findings over the years. Local MAHs have fewer major findings, with [104, (9.3%)] peaking in 2022. Regarding inspection topics, managing and reporting adverse reactions emerged as a critical area alongside significant findings related to the Pharmacovigilance System Master File and the Qualified Person Responsible for Pharmacovigilance (QPRP). Areas such as Clinical Trials and Archiving showed minimal findings during the inspection.

conclusionThis study highlights significant disparities in inspection findings among MAHs from 2019 to 2022, noting an initial rise in major findings, particularly among international MAHs, followed by a decline by 2022. Key inspection topics, like pharmacovigilance practices, emphasize the need for robust systems to manage adverse reactions, focusing on the Pharmacovigilance System Master File and the QPRP. While some areas, had minimal findings, the study stresses the importance of continuous improvement in pharmacovigilance systems for patient safety. It promotes the enhancement of training and compliance measures across MAHs to address deficiencies and ensure regulatory adherence. Provided insights for stakeholders may improve pharmacovigilance and overall regulatory standards in the pharmaceutical industry.