The Ethiopian Food and Drug Authority (EFDA) registers all medical products; licenses and regulates the production, import, storage, and distribution of trans-regional medical products; and conducts quality control testing and post-marketing surveillance of medical products circulating in the local market. Regulatory activities that are not part of EFDA’s mandate fall under the jurisdiction of regional government and city administration regulatory bodies. However, the unclear mandates of EFDA and regional regulatory bodies (RRBs), lack of a formal reporting relationship among them, and poor RRB capacity compromise the proper regulatory oversight of medical products.
PQM+ is building the capacity of EFDA and the regional regulatory bodies to monitor the quality of items in the medical product supply chain and strengthen the various bodies’ working relationships to carry out their mandates more efficiently. PQM+ also helps build local manufacturers’ capacity to meet international standards, ensuring that locally produced medical products are of good quality and can help meet country demand. In addition, PQM+ is supporting the government’s response to the COVID-19 pandemic.
