Democratic Republic of the Congo

Pharmacovigilance activities in the Democratic Republic of the Congo are overseen by the Autorité Congolaise de Réglementation Pharmaceutique (ACOREP) and the national pharmacovigilance system. The national pharmacovigilance guidelines require pharmaceutical MAHs to establish a pharmacovigilance service under a qualified QPPV and maintain a Pharmacovigilance System Master File (PSMF) available for audit or inspection. MAHs must collect adverse-effect information and provide PSUR/PBRER and DSUR information, post-marketing safety data and a risk-management plan when needed. Fatal or life-threatening serious unexpected adverse reactions must be reported as soon as possible and no later than 7 calendar days, with follow-up within an additional 15 days; other serious unexpected reactions must be reported within 15 calendar days, while non-serious and non-unexpected reactions may be reported within 90 calendar days. The framework also covers signal management, post-marketing safety activities, audits and inspections. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): How to Prepare and Comply with a Pharmacovigilance Inspection.