Lessons from Ethiopian Pharmaceutical Regulatory Landscape: A Risk-Based Approach to Address Challenges and Unlock Opportunities

Hassen Kebede Hassen¹Yesuneh Tefera Mekasha^2*Addisu Afrassa Tegegne³Yildiz Ozalp⁴

• ¹Veterinary Drug and Feed Control and Administration Authority, Addis Ababa, Ethiopia, Addis Ababa, Ethiopia
• ²Pharmaceutical Sciences, Pharmaceutical Quality Assurance and Regulatory Affairs, University of Gondar, Gondar, Amhara Regional State, Ethiopia, Gondar, Ethiopia
• ³2Pharmaceutical Sciences, Pharmaceutical Quality Assurance and Regulatory Affairs, University of Gondar, P.O.BOX:196, Gondar, Ethiopia, Gondar, Ethiopia
• ⁴Department of Pharmaceutical Technology, Faculty of Pharmacy, Near East University, Nicosia, CYPRUS., Istanbul, Türkiye

Background: Pharmaceutical products are essential for disease prevention, treatment and for public health promotion. With the rapid growth of the global pharmaceutical industry in bulk and variety, ensuring the safety and efficacy become critical. However, in resource-limited settings like Ethiopia, problems in regulatory system and lack of updated quality information hamper access to quality medicines.Objectives: This study was conducted from September 2021 to December 2023, to explore the challenges and opportunities within Ethiopia's pharmaceutical regulation using retrospective data and through analysis of current regulatory perspectives in human medicinal products.The retrospective data revealed 21.4 % of product samples taken from the market were found to be of poor quality. Cross-sectional regulatory analysis indicated constraints within the current supply chain, such as suboptimal supply volumes (36.17%), insufficient variety of medicines (55.32%), issues related to foreign currency (65.96%), the presence of varying degree of corruption at any one of the segments in regulatory system (85%) and dependency on previous brands (27.7%) have been indicated. From focal group discussions with regulatory experts, problems in application backlogs within regulatory authority (EFDA) are indicated. From expert opinion-based analysis on regulatory risk, suboptimal performance (RPN=75), lack of transparency and consistency (RPN=64), problems in traceability and documentation are identified as main risk factors contributing to regulatory failure. Preparation of guidelines for all activities, adherence to established guidelines, standard protocols, service timing SOPs, and the use of online process monitoring schemes were indicated as the most effective mechanisms to manage the likelihood of regulatory failures.The challenges within the regulatory processes are reflected by the presence of poor-quality products in post-marketing study findings, deficiencies in regulatory enforcement and services indicated during interactive assessment. The pharmaceutical supply encounters issues with potential impact on the safety and efficacy of medicines. The findings thus indicate the need for designing the system based on perceived risk analysis and improving regulatory infrastructure that can better mitigate quality and safety concerns.