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

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.