Niger

Pharmacovigilance in Niger is currently overseen by the Agence Nigerienne de Reglementation du Secteur Pharmaceutique (ANRP), an autonomous public regulatory body under the Ministry of Health whose official missions include strengthening regulatory control and the safety of health products. Within the ANRP, pharmacovigilance activities fall under the Direction Vigilances, Usage rationnel et Essais cliniques (DVUE). The national vigilance system was originally structured through Arrete No. 253/MSP/DGSP/DPH/MT of 22 July 2014, which establishes the national and regional vigilance bodies, requires public and private organisations exploiting health products to declare reported adverse effects immediately, and assigns responsibility for receiving, evaluating and acting on notifications. The framework was updated by Arrete No. 380 MSHP/ANRP/DG/DVUE of 22 September 2025, determining the organisation and operating arrangements of the Systeme National des Vigilances. However, the currently accessible official material does not clearly publish a comprehensive MAH-specific GVP standard establishing a Niger-resident QPPV, a PSMF requirement, universal numerical ICSR deadlines beyond the immediate-reporting language, fixed PSUR/PBRER frequencies, a standardized RMP format or a routine pharmacovigilance-inspection cycle applicable to every MAH. These points should therefore be confirmed with ANRP/DVUE or in product-specific authorisation conditions rather than inferred from EU or other foreign GVP systems. Companies requiring operational support may use specialised pharmacovigilance services. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.