Benchmarking of Saudi pharmacovigilance inspection standards across international regulatory authorities.

Pharmacovigilance (PV) inspections are a key regulatory tool to ensure marketing authorization holders (MAHs) comply with safety requirements. The Saudi Food and Drug Authority (SFDA) regulates PV in accordance with its Saudi Good Pharmacovigilance Practices (Saudi GVP) guideline. Despite the worldwide standards established by the World Health Organization (WHO) and the International Council for Harmonisation (ICH), inspection practices differ, necessitating benchmarking to enhance conformity with international best practices. The objective of this study is to benchmark the Saudi Food and Drug Authority (SFDA) pharmacovigilance inspection system against international practices to enhance regulatory oversight and provide insights into inspection trends over years. This is a comparative benchmarking study that reviewed the pharmacovigilance inspection frameworks of the Saudi Food and Drug Authority (SFDA), the European Medicines Agency (EMA), and the U.S. Food and Drug Administration (FDA). A mixed-methods approach was used, drawing on secondary data sources, including both quantitative and qualitative content derived from official regulatory inspection documents. The three regulatory authorities shared core pharmacovigilance inspection elements, including risk-based inspection planning, inspector qualification, and management of corrective and preventive actions (CAPA), while differing in several operational aspects. Structured global regulatory reliance mechanisms were established within the EMA and FDA frameworks but remained limited within the SFDA framework. The SFDA and EMA classified findings as critical, major, or minor, while the FDA used outcome-based categories (OAI: Official Action Indicated; VAI: Voluntary Action Indicated; NAI: No Action Indicated) and Form 483 to point out objectionable conditions. CAPA timelines varied: the SFDA established a 30-day period, the EMA modified timelines based on severity, and the FDA mandated a 15-day timeframe. The SFDA has established a solid, risk-based pharmacovigilance inspection system, reflecting strong regulatory capacity, while the development of structured global regulatory reliance mechanisms represents an opportunity to further strengthen the SFDA pharmacovigilance inspection framework. This would further align SFDA practices with international standards and strengthen Saudi Arabia's leadership in pharmacovigilance.