VIGILANCE AND CLINICAL TRIAL OVERSIGHT SYSTEM IN RWANDA.

The presentation provides an overview of Rwanda FDA’s regulatory functions in pharmacovigilance (PV) and clinical trial (CT) oversight. Established in 2018, Rwanda FDA operates under the Ministry of Health and has achieved WHO GBT Maturity Level 3, indicating a robust regulatory system. The agency regulates a wide range of products including medicines, vaccines, medical devices, and food supplements. Its PV system is governed by national laws and guidelines, enabling activities such as adverse event reporting, signal detection, causality assessment, safety communication, and inspections. Rwanda FDA uses digital tools like PViMS, Vigimobile, and VigiFlow for data collection and reporting to WHO. Several safety alerts have been issued for medicines like fluoroquinolones, tramadol, and lamotrigine. In clinical trials, Rwanda FDA oversees authorization, inspection, and monitoring, with clear guidelines and timelines for routine, expedited, and emergency reviews. An online portal facilitates CTA submissions, and inspections focus on facilities, documentation, and GCP compliance. Between 2019 and 2025, 46 clinical trials were authorized across various phases and disease areas including malaria, TB, COVID-19, and mental health. Despite challenges like underreporting and limited training, opportunities exist through government support, hospital-level PV committees, and functional systems and tools.