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

Background: Pharmaceutical products are essential for disease prevention, treatment, and public health promotion. With the rapid growth of the global pharmaceutical industry in terms of bulk and variety, ensuring the safety and efficacy becomes critical. However, in resource-limited settings like Ethiopia, problems with the regulatory system and a lack of updated quality information hamper access to quality medicines. Objectives: This study, conducted from September 2021 to December 2023, aimed to examine the challenges and opportunities within Ethiopia's pharmaceutical regulation, using retrospective data and analyzing current regulatory perspectives on human medicinal products. Methods: Retrospective data from published online databases, such as Google Scholar, PubMed, and Web of Science, are searched using specific keywords. Cross-sectional regulatory analysis undertaken through a focus group discussion and questionnaire survey on regulatory experts and stakeholders from the supply chain. The data were organized, filtered for relevance, and analyzed descriptively, with findings presented through tables, flowcharts, and contextual narratives. Results: The retrospective data revealed that 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 focus group discussions with regulatory experts, it is evident that the regulatory authority (Ethiopian Food and Drug Authority (EFDA)) faces problems with application backlogs. From expert opinion-based analysis on regulatory risk, suboptimal performance (risk priority number (RPN) = 75), lack of transparency and consistency (RPN = 64), and problems in traceability and documentation are identified as primary risk factors contributing to regulatory failure. Preparation of guidelines for all activities, adherence to established policies, standard protocols, service timing standard operating procedures (SOPs), and the use of online process monitoring schemes were indicated as the most effective mechanisms to manage the likelihood of regulatory failures. Conclusion: 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 chain faces challenges that could impact the safety and efficacy of medicines. The findings thus suggest the need to design the system based on perceived risk analysis and improve the regulatory infrastructure that can better mitigate quality and safety concerns.