Madagascar

Pharmacovigilance in Madagascar is coordinated through the national medicines authority and the country’s pharmacovigilance structures. Madagascar has recently strengthened national adverse-event reporting: the French-language WHO Africa report on the lancement de VigiMobile à Madagascar confirms the April 2026 launch of VigiMobile with the Agence du Médicament de Madagascar to facilitate reporting of suspected adverse effects by health professionals and patients. This supports an active national post-market safety-surveillance system and reinforces the expectation that companies supplying medicines must cooperate with national safety monitoring and provide relevant safety information when requested. However, the current publicly accessible official material reviewed does not clearly publish a comprehensive MAH-specific GVP framework defining a mandatory Madagascar-resident QPPV, a PSMF requirement, universal numerical ICSR timelines for MAHs, fixed PSUR/PBRER frequencies, a standardized RMP format, or a routine pharmacovigilance-inspection cycle. These points should therefore be verified with the competent authority or against product-specific authorisation conditions rather than inferred from EU GVP. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.