Increasing the Sustainability of Ethiopia’s Medicines Quality Assurance System by Building Local Service Capacity

The agreement, finalized in July 2018, marks a significant milestone in strengthening EFMHACA's organizational sustainability by reducing service costs through local contracting. NMIE's involvement has expanded its technical capacities, enabling the Institute to provide calibration services for NQCL, thereby reducing the Authority's reliance on foreign providers. Prior to the partnership, EFMHACA had been outsourcing calibration services to an international contractor, which resulted in a significant financial strain on the Authority's limited resources. The annual cost of international contracting was USD15,000, which impeded EFMHACA's drive toward self-sustainability. The partnership with NMIE has reduced the yearly calibration cost at NQCL by 87 percent to USD2,000, which EFMHACA can now fund from its own budget. This reduction in costs has contributed to the Authority's organizational sustainability. The partnership between EFMHACA and NMIE was facilitated by the Promoting the Quality of Medicines (PQM) program, which is funded by the U.S. Agency for International Development (USAID) and implemented by the U.S. Pharmacopeial Convention (USP). PQM's technical assistance and training enabled NMIE to receive ISO accreditation for calibration of temperature and pressure instrumentation in 2017 and subsequently expand its scope to include length and dimension calibrations in 2018. The partnership has also enabled NMIE to offer its services to other calibration clients in Ethiopia, including pharmaceutical manufacturing sites, pharmaceutical manufacturing sites, and diagnostic laboratories. This expansion of services has the potential to improve the quality of medicines and diagnostic products in the country, thereby contributing to the acceleration of universal health coverage and the promotion of well-being for all people of all ages. The partnership between EFMHACA and NMIE demonstrates the importance of building local capacity for quality control and calibration services in low- and middle-income countries. By strengthening the quality assurance system, the partnership has contributed to the sustainability of EFMHACA and has the potential to improve the quality of medicines and diagnostic products in Ethiopia.