Ghana

The Food and Drugs Authority (FDA) Ghana is the primary national regulatory authority responsible for the registration, licensing, and post-market surveillance of health products, including pharmaceuticals, medical devices, diagnostics, and digital health solutions. The FDA operates under the Food and Drugs Authority Act, 2012 (Act 851), which provides the legal framework for the regulation of all health commodities in Ghana. The approval process generally involves submission of a registration dossier, technical review by the FDA's relevant product division, and where required, product sampling and laboratory testing. Products are classified by risk level, with higher-risk products subject to more rigorous review pathways. The FDA is also a member of the African Medicines Regulatory Harmonization (AMRH) initiative and participates in regional harmonization efforts under the West African Health Organisation (WAHO) and the African Union's African Medicines Agency (AMA) framework.

Key submission requirements include the appointment of a local regulatory representative or agent who is registered with the FDA and who assumes legal responsibility for the product within Ghana. Dossiers are generally accepted in the Common Technical Document (CTD) format, and the FDA increasingly aligns its review standards with international guidelines from the International Council for Harmonisation (ICH) and the World Health Organization (WHO) prequalification program. WHO prequalified products may benefit from an expedited or abridged review pathway, reducing timelines significantly. The FDA has undertaken notable reforms in recent years, including the introduction of an electronic submission portal to improve transparency and efficiency, the establishment of a Medical Devices and Diagnostics unit with dedicated review pathways, and the adoption of risk-based classification frameworks for medical devices broadly aligned with GHTF and IMDRF principles. Post-market surveillance obligations, including adverse event reporting and periodic safety updates, apply to all registered products.

Public sector procurement of health products in Ghana is centrally coordinated through the Ministry of Health (MOH) and its implementing agencies, primarily the Ghana Health Service (GHS) and the Public Procurement Authority (PPA). The PPA oversees adherence to the Public Procurement Act, 2003 (Act 663, as amended by Act 914 in 2016), which governs tendering, supplier prequalification, and contract award processes for government entities. The central medical store function is managed through the Ghana Medical Supplies (GMS), a limited liability company under the MOH, which serves as the primary warehousing and distribution entity for public health facilities. National tender processes are typically conducted at the central level, with framework contracts awarded to prequalified suppliers. Teaching hospitals and regional health directorates may also conduct independent procurement within defined thresholds, creating a layered procurement environment across central, regional, and facility levels. The National Health Insurance Authority (NHIA) plays a significant role in reimbursement and demand generation, as products must generally appear on the National Health Insurance Scheme (NHIS) medicines list to be procured and reimbursed through public channels.

The private sector constitutes a substantial and growing share of health product distribution in Ghana, served by a network of licensed importers, distributors, and retail pharmacies regulated by the FDA and the Pharmacy Council of Ghana. Donor-funded procurement channels are critically important, particularly for essential medicines, vaccines, diagnostics, and health commodities in priority disease areas. Key donors and procurement agents active in Ghana include UNICEF Supply Division, the Global Fund to Fight AIDS, Tuberculosis and Malaria, USAID through its global health supply chain programs such as the Global Health Supply Chain Program-Procurement and Supply Management (GHSC-PSM), and Gavi, the Vaccine Alliance, which supports immunization procurement through coordinated government channels. Products procured through these channels are frequently required to hold WHO prequalification or approval from a Stringent Regulatory Authority (SRA). Ghana has adopted policies encouraging local manufacturing development, including preferences within public procurement frameworks for locally manufactured products where quality and supply capacity can be demonstrated, aligned with the broader Africa CDC and African Union agenda to strengthen domestic pharmaceutical production across the continent.