Pharmacovigilance Seminar

On 5th and 6th June 2025, our partners from Ethiopian Food and Drug Authority (EFDA) and Tanzania Medicines and Medical Devices Authority (TMDA) sent representatives to participate in the seminar among other regulators from Africa and Europe. They presented a comprehensive overview of safety monitoring activities at EFDA, highlighting both pre-market (clinical trials) and post-market (pharmacovigilance) systems. The presentation emphasized EFDA’s regulatory processes, challenges in adverse event reporting, the role of the National Pharmacovigilance Center, and future plans to improve reporting culture, leverage technology, and strengthen risk communication and collaboration for enhanced public health protection. The representative from TMDA gave an overview of pharmacovigilance activities in Tanzania mainland, highlighting the role of TMDA. The presentation covered the regulatory framework, systems for monitoring medicine safety (both passive and active), processes for investigating adverse events following immunization (AEFI), and the achievements and challenges faced in strengthening pharmacovigilance systems in Tanzania. The event was hosted by the University of Oslo coordinated-EDCTP3 project, AccessAfrica2, in coordination with Gispen4Regulatory Science, with additional funding from The Norwegian Research Council.