Cameroon

Pharmacovigilance in Cameroon is coordinated by the Direction de la Pharmacie, du Médicament et des Laboratoires (DPML). The official Cameroon Pharmacovigilance Guidelines organize the national pharmacovigilance system and were circulated for implementation to health facilities, public-health programmes, pharmaceutical laboratories, manufacturers and distributors. A separate ministerial circular on designation of a qualified pharmacovigilance responsible person instructs the covered establishments to designate a qualified person responsible for pharmacovigilance who works closely with DPML/CNPV. The current public DPML sources do not establish an EU-style QPPV-residency or PSMF requirement or universal PSUR/RMP timelines; only the specific national requirements and product conditions should be stated. Where the cited public sources do not expressly define ICSR reporting route and timelines, signal management and audit and inspection arrangements, the MAH should confirm the current product-specific requirements with the competent authority and against the marketing-authorisation conditions. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.