Ethiopia

Pharmacovigilance activities in Ethiopia are regulated by the Ethiopian Food and Drug Authority (EFDA) under the Pharmacovigilance Directive No. 932/2022 and the National Pharmacovigilance Guideline, Version 004 (2024). MAHs must maintain a pharmacovigilance system and PSMF, appoint a QPPV, submit applicable PSUR/PBRERs and RMPs, monitor published scientific literature and safety signals, and comply with post-marketing safety and pharmacovigilance inspection requirements. EFDA has further required MAHs to appoint a QPPV residing in Ethiopia. The framework also provides for pharmacovigilance inspections and self-audits, including routine, system/product, for-cause and follow-up activities. Where the cited public sources do not expressly define ICSR reporting route and timelines, 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): How to Prepare and Comply with a Pharmacovigilance Inspection.