ISoP MENA Chapter: Strategic Development and Future Directions Following a Decade of Strengthening Pharmacovigilance in the Middle East and North Africa

Abstract

Pharmacovigilance (PV) in the Middle East and North Africa (MENA) region has advanced substantially over the past decade, driven by diverse surveillance methodologies, expanded pharmacological knowledge and innovative approaches, including artificial intelligence (AI) and real-world data and real-world evidence, to enhance medicine safety and prevent patient harm .

Many national PV centres across the MENA region joined the World Health Organization (WHO) Programme for International Drug Monitoring during the 1990 s and early 2000 s and subsequently established national PV systems . However, considerable heterogeneity remains across the region, with PV systems that range from well-established programmes to initiatives that are still in the early stages of development .

Ensuring the safe and effective monitoring of medicines in routine clinical practice remains challenging and requires collaboration among a broad range of stakeholders, including medicines regulatory authorities, pharmaceutical companies, academic institutions, healthcare professionals, policymakers and patient organisations . Recognising the need to strengthen regional collaboration, build capacity and promote stakeholder engagement in PV, the International Society of Pharmacovigilance (ISoP), with the support of its Executive Committee (2012–16), launched the Middle East Chapter during its Annual Meeting in Prague, Czech Republic, in October 2015 .