Pharmacovigilance infrastructure and post-marketing surveillance system capacity building for regional medicine regulatory harmonization in East Africa. This project aims to strengthen regulatory capacity on pharmacovigilance (PV), which strengthens the regulatory platform of CDT-Africa. It plans to assess current PV policies, regulations, and infrastructures; introduce comprehensive intervention programs and good PV practices; generate cohort of PV trained staff working in national regulatory authorities; and provide Interregional training of trainers’ course on PV. It consists of six work packages to execute in collaboration with the Ethiopian Food, Medicine and Health Care Administration and Control Authority (EFMHACA). The project’s expected outcome includes national PV infrastructure, post-marketing surveillance and regulatory capacity for clinical trial safety data management; a cohort of PV trained manpower generated; twelve advanced trained personnel (4 PhD and 8 MSc) on top of those getting short courses both in-country and abroad in PV; provision and adoption of PV tools and technical support in adverse drug reaction reporting system; and PV networking among regulatory authorities, universities and international collaborators. The project is a consortium of six countries, namely Sweden, the Netherlands, Ethiopia, Kenya, Rwanda and Tanzania. EDCTP funds the project with €3 million for a total duration of 60 months.