Pharmacovigilance programmes have the dual aims of detecting potential safety issues related to poor quality pharmaceutical products as well as rapidly identifying unanticipated adverse events associated with medication use in the population. The aim of this chapter is to provide insight into the particular challenges and opportunities for pharmacovigilance development in the Arab world. An overview of the current state of public health and pharmacovigilance policies in the region is also discussed. While there has been little empirical work that has systematically studied this topic, what is known is that there exist wide disparities in the extent of pharmacovigilance development and pharmaceutical spending in countries of the region. Further, weak regulatory environments have allowed for the inappropriate and unsafe use of medications, including over-the-counter products and herbals, to flourish. In the absence of a robust surveillance system monitoring the use of medications at the national level and given the paucity of locally based, comprehensive, and reliable research evidence, the population health implications of unchecked pharmaceutical practice patterns are unclear. The growing global emphasis on pharmacovigilance has encouraged countries in the Arab world to take on drug safety policy as a central pillar of health policy reform, but significant challenges have hindered progress. The primary challenges to pharmacovigilance development in the Arab world are lack of public health funding, lack of political commitment and policy prioritization of pharmacovigilance, low interest of donors and development agencies, inadequately trained staff and scarce training opportunities, weak enforcement of pharmaceutical policies, inadequate regulation of the pharmaceutical market, and underreporting of adverse drug reactions. The greatest opportunities for improved pharmacovigilance development will come from consensus building with the public, policy-makers, and healthcare practitioners; incorporating pharmacovigilance training into the educational curricula of health professionals; consolidating healthcare utilization and outcomes data and other critical resources regionally; improving the use of modern information technology; building better governance through accountable and transparent regulations and enforcement mechanisms; and perhaps most importantly, centering the patient narrative in the reframing of pharmacovigilance by incorporating public perspectives in the construction and development of programmes and policies. The renewed global and regional emphasis on patient safety and healthcare quality is cause for optimism that the goals for pharmacovigilance development can and will be realized in the near future.