Abstract

European Union (EU) and Middle East North Africa (MENA) are similar in their approach to pharmacovigilance guidelines. Both regions intend to harmonize Pharmacovigilance (PV) practices across the countries in the respective regions; however, based on the healthcare and regulatory system of each country, there are differences in implemented practices. PASS studies fall under additional PV activities in the Risk Management Plan (RMP) that a company plans to execute. They help identify and characterise risks, collect missing information and evaluate the effectiveness of risk minimisation measures. Risk management is a global activity; however, due to differences in healthcare systems between countries and regions, indication, target population and risk minimisation measures might vary. In addition, differences in disease prevalence and severity might also lead to various degrees of benefits. Therefore, a product might need different measures in the RMP to manage risks, while the core would still be common for all.