The Rwanda FDA regulates medicines through robust pharmacovigilance and clinical trial systems, including post-marketing surveillance to ensure the safety of medical products. Both electronic and paper-based tools are used to report adverse events, and international databases are accessed as part of the International Drug Monitoring System. Advisory committees assist with risk assessments, while public health programs, healthcare institutions, and the academic sector play a key role in safety monitoring. Marketing authorisation holders are responsible for managing risks and reporting safety issues in accordance with clear and timely communication guidelines.

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