Rwanda

Pharmacovigilance in Rwanda is regulated by the Rwanda Food and Drugs Authority (Rwanda FDA). The Authority’s official Guidelines on Safety and Vigilance of Medical Products and Health Technologies require marketing authorisation Holders (MAHs) to maintain an effective pharmacovigilance system, appoint a qualified person for pharmacovigilance, collect and evaluate safety information, manage signals, and implement risk-management and regulatory communication activities. The guideline addresses individual case safety reporting, periodic benefit-risk evaluation, risk-management plans, record retention, and pharmacovigilance inspections, with the applicable timelines and submission expectations determined by the type and seriousness of the safety information. Applicants for emergency-use products must also provide an RMP and appoint a QPPV under the Authority’s Emergency Use Authorization Guidelines. Companies should keep system documentation current, maintain oversight of outsourced activities, ensure follow-up and data-quality controls, and remain inspection-ready. Current operational instructions and electronic submission requirements should be confirmed directly with Rwanda FDA for each authorised product. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): How to Prepare and Comply with a Pharmacovigilance Inspection.