The absence of regulatory systems to monitor the quality, safety, and efficacy of medicines can compromise the overall effectiveness of health care services and endanger the public health. A strong regulatory system is considered an essential component of a health system. In Ethiopia, the Food, Medicine and Health Care Administration and Authority (FMHACA), formerly known as the Drug Administration and Control Authority, regulates the country’s pharmaceutical sector in an environment vulnerable to drug smuggling and the circulation of substandard medicines. USAID/SIAPS and its predecessor program Strengthening Pharmaceutical Systems (SPS) have provided critical support to Ethiopia’s FMHACA to strengthen its regulatory and enforcement capacity to deter deadly counterfeit drugs from crossing the border.
