Ghana

The Food and Drugs Authority (FDA) Ghana is the primary national regulatory authority responsible for ensuring the safety, quality, and efficacy of health products including pharmaceuticals, medical devices, diagnostics, and digital health solutions. The FDA operates under the Food and Drugs Act, 2012 (Act 851), which provides the comprehensive legal framework for product registration, post-market surveillance, and enforcement. All health products intended for sale or distribution in Ghana must be registered with the FDA prior to market entry, and the authority employs a risk-based classification system to determine the level of scrutiny applied during review. Applications are submitted through the FDA's online portal and are assessed by technical review teams covering pharmacology, clinical data, manufacturing standards, and labeling compliance.

Applicants are required to submit a local regulatory representative or agent who is registered with the FDA and assumes legal responsibility for the product on the Ghanaian market. Dossiers are generally accepted in the Common Technical Document (CTD) format, and the FDA increasingly recognizes review outcomes from stringent regulatory authorities (SRAs) such as the EMA, US FDA, and WHO Prequalification as part of its reliance and worksharing frameworks. Ghana is an active member of the African Medicines Regulatory Harmonization (AMRH) initiative and participates in the African Union Development Agency (AUDA-NEPAD) harmonization program, as well as the African Medicines Agency (AMA) framework. Recent reforms have focused on digitizing the submission and tracking process, streamlining review timelines for priority health products, and expanding the reliance pathway to accelerate access to essential medicines and medical technologies.

Public procurement of health products in Ghana is coordinated primarily through the Ministry of Health (MOH) and its implementing agencies, most notably the Ghana Health Service (GHS). The Public Procurement Authority (PPA), established under the Public Procurement Act, 2003 (Act 663, as amended by Act 914), governs all public sector procurement processes, including health commodities. National tender processes are managed through centralized mechanisms at the MOH level, with the Ghana Health Service overseeing distribution through the network of regional health directorates and facility-level procurement. The Pharmacy Council of Ghana also plays a role in regulating the supply chain for medicines, while the Central Medical Stores (CMS) serves as the primary warehousing and distribution hub for public sector health commodities. Procurement decisions are guided by national essential medicines lists and health technology assessment considerations, and products must hold valid FDA registration to be eligible for public tender.

Ghana receives significant support from multilateral and bilateral donors, with procurement channels including the Global Fund to Fight AIDS, Tuberculosis and Malaria, USAID through the GHSC-PSM and PMI programs, UNICEF Supply Division, and Gavi the Vaccine Alliance, which collectively fund a substantial portion of commodities for HIV, malaria, tuberculosis, immunization, and reproductive health programs. Products procured through these channels must meet international quality standards, including WHO Prequalification or SRA approval, in addition to local FDA registration requirements. Ghana has a stated policy interest in promoting local manufacturing as part of its broader Africa Continental Free Trade Area (AfCFTA) and domestic industrialization agenda, with the MOH and FDA providing conditional incentives and expedited review pathways for locally manufactured products. The Ghana National Pharmaceutical Policy and the Local Content and Local Participation frameworks further encourage procurement preferences for domestically produced health commodities where quality and supply capacity can be assured.