An Overview of the Allopathic Drug Registration Process and Requirements in Ghana

Ghana is one of the most developed countries in the West African region, second only to Ivory Coast. The Food and Drug Authority (FDA) of Ghana regulates the quality, safety, and efficacy of medicinal products. Recently, the government has increased its focus on the healthcare sector, allocating a free zone to promote in-house manufacturing of pharmaceutical products. Drug product registration in Ghana is less complex compared to other developing African countries. Recently, Ghana's National Regulatory Authority (NRA) achieved maturity level 3 according to the WHO GBT scheme. The FDA accepts dossiers in the Common Technical Document (CTD) format as per the ICH guidelines (M4). Additionally, there are special provisions to fast-track the registration process. However, the FDA is still behind in terms of dossier submission via eCTD software, and there is no way to track applications after submission; applicants must visit physically to check the status. Nevertheless, Ghana is continuously improving its processes with the help of the WHO to streamline the registration process. This paper summarizes the process and requirements for the registration of allopathic drugs in Ghana.