September 10, 2025Frontiers in MedicineOpen Access

Lessons from Ethiopian pharmaceutical regulation: a risk-based approach to overcome challenges and unlock opportunities

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Poor quality products were found in 21.4% of market samples, indicating significant regulatory failures.
Major constraints identified include insufficient variety of medicines (55.32%) and a high degree of corruption (85%).
Focus group discussions highlighted issues within the Ethiopian Food and Drug Authority, including application backlogs and lack of transparency.
Recommendations include developing guidelines and standard operating procedures to enhance regulatory oversight and mitigate risks.

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Analysis reveals significant issues in pharmaceutical regulation in Ethiopia, suggesting risk-based solutions to improve quality and access.

Hassen et al. (2025) studied this question.

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Analysis reveals significant issues in pharmaceutical regulation in Ethiopia, suggesting risk-based solutions to improve quality and access.