Eritrean Pharmacovigilance System: Key Strategies, Success Stories, Challenges and Lessons Learned.

Establishing a mature pharmacovigilance system in a low-income country is a challenge. Nevertheless, Eritrea, one such low-income country, was able to achieve a fully fledged pharmacovigilance system within a period of almost 9 years. In the last five years (2014-2019), the Eritrean Pharmacovigilance Centre has submitted, on average, 646 individual case safety reports (ICSRs) per million inhabitants per year to the World Health Organization (WHO) global database of ICSRs. As a result, Eritrea has been rated among the top reporting countries in Africa. The center has detected about 30 safety signals, achieved maturity level three on the WHO rapid benchmarking assessment, and gained huge political commitment. In the last few years, monitoring of product quality through the pharmacovigilance system found approximately 55 medical products that were either substandard or falsified and were subsequently recalled from the Eritrean market by the National Medicines and Food Administration. The aim of this article is to describe Eritrea's success stories, key strategies for success, challenges encountered, and lessons learned to share them with the international pharmacovigilance community and beyond.