Saudi Arabia

Pharmacovigilance activities in Saudi Arabia are regulated by the Saudi Food and Drug Authority (SFDA) under the Saudi Good Pharmacovigilance Practice Guideline, Version 4.0. Each pharmacovigilance system must have one full-time local QPPV who resides and performs the role in KSA and is registered with the SFDA, with documented back-up arrangements. The PSMF must be located in KSA; multinational MAHs must also maintain a current national PSSF. The MAH must meet Saudi requirements for ICSR and local-literature reporting, PSUR/PBRER submission, signal management, RMPs and risk-minimisation measures, audits and inspections. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Difference in QPPV Nomination Between EU and KSA; PSMF Maintenance: Concept and Importance in Pharmacovigilance.