Somalia

Pharmacovigilance in Somalia is being developed under the National Medicines Regulatory Authority (NMRA), operating within the federal health framework. The Authority’s official regulatory-functions page identifies pharmacovigilance and vigilance systems as a core function and confirms that NMRA operates an adverse-drug-reaction reporting system to collect, assess and act on post-market safety data. The legal establishment of the interim authority is documented in the NMRA establishment instrument. Companies supplying medicines should therefore establish practical arrangements for collecting and assessing safety information, keep traceable records, promptly communicate serious or important safety concerns and cooperate with NMRA post-market surveillance, recalls and regulatory requests. However, currently accessible official material does not clearly publish universal numerical ICSR deadlines, a mandatory locally resident QPPV, a national PSMF format or location, fixed PSUR/PBRER frequencies, a standard RMP format or a routine PV-inspection cycle for every MAH. These items should be confirmed with NMRA during registration and post-authorisation maintenance and should not be replaced by requirements from another jurisdiction. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.