Background: Access to quality medicines is a global initiative to ensure universal health coverage. However, the limited capacity of National Medicines Regulatory Authorities (NMRAs) to prevent and detect the supply of poor-quality medicines led to the predominance of sub-standard and falsified (SF) medicines in the supply chains of many countries. Therefore, this study was designed to assess the capacity of a young NMRA to ensure the quality of medicines with Rwanda as a case study.
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