Eritrea

Pharmacovigilance activities in Eritrea are coordinated by the National Pharmacovigilance Centre within the National Medicines and Food Administration under the Ministry of Health. The national pharmacovigilance system supports adverse drug reaction reporting and assessment, signal detection, post-marketing monitoring and regulatory action, and Eritrea has been a full member of the WHO Programme for International Drug Monitoring since 2012. Publicly available Eritrean government information does not establish detailed MAH-specific requirements for a locally resident QPPV, PSMF/PSSF, fixed MAH ICSR reporting timelines, routine PSUR/PBRER periodicity or universal mandatory RMP submission. Product-specific obligations should therefore be confirmed with the National Medicines and Food Administration. Where the cited public sources do not expressly define 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.