Mali

Pharmacovigilance in Mali is organised under the national medicines regulatory system, with the Direction de la Pharmacie et du Médicament (DPM) and national pharmacovigilance structures responsible for coordinating medicine-safety surveillance. The French-language Arrêté n° 2011-4201/MS-SG du 14 octobre 2011, available from the DPM as the arrêté fixant les modalités de mise en œuvre de la pharmacovigilance, establishes the organisation of the national system and covers reporting, collection and assessment of suspected adverse effects. The framework supports continued post-market monitoring and cooperation by medicine suppliers with the competent national structures. However, the current publicly accessible national material reviewed does not clearly establish an EU-style mandatory local QPPV, a PSMF requirement, a universal numerical MAH ICSR deadline, fixed PSUR/PBRER frequencies, a standardized RMP format, or a routine pharmacovigilance-inspection frequency applicable to every MAH. These elements should be confirmed with the DPM/competent authority or through product-specific authorisation conditions rather than inferred from foreign GVP systems. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.