Ghana

The Food and Drugs Authority (FDA) Ghana is the primary national regulatory authority responsible for regulating health products in Ghana, operating under the Food and Drugs Authority Act, 2012 (Act 851). The FDA oversees the registration, licensing, and post-market surveillance of pharmaceuticals, medical devices, diagnostics, and health-related digital solutions. All health products intended for sale or distribution in Ghana must undergo a product registration process with the FDA, which evaluates safety, quality, and efficacy before granting market authorization. The review process involves administrative screening, technical dossier evaluation, and, where applicable, product testing by FDA-accredited laboratories.

Applicants are required to submit dossiers in accordance with the Common Technical Document (CTD) format, with the FDA also accepting submissions aligned with the African Union Development Agency (AUDA-NEPAD) harmonized technical guidelines. A local regulatory representative or Ghana-registered entity is typically required to anchor the registration application. The FDA has been actively engaged in regional harmonization efforts through the African Medicines Regulatory Harmonization (AMRH) initiative and the African Medicines Agency (AMA), and has introduced reforms to streamline review timelines, including abridged and expedited review pathways for products already approved by stringent regulatory authorities (SRAs) such as the EMA, US FDA, or WHO-prequalified products. Digital health products and in vitro diagnostics (IVDs) are subject to specific regulatory guidelines issued by the FDA, reflecting growing emphasis on these product categories.

Public procurement of health products in Ghana is coordinated primarily through the Ministry of Health (MOH) and its implementing agencies, including the Ghana Health Service (GHS) and the National Health Insurance Authority (NHIA). The Public Procurement Authority (PPA), established under the Public Procurement Act, 2003 (Act 663, as amended by Act 914 in 2016), governs procurement processes across all public entities, including health sector institutions. Central medical procurement is managed through the Ghana Health Service Supply Chain directorate and the Central Medical Stores (CMS), which coordinates tenders and framework contracts for essential medicines and health commodities. Procurement decisions are influenced by the Ghana Essential Medicines List and national treatment guidelines, and health facilities under the NHIA reimbursement scheme must procure listed products to qualify for claims.

Ghana benefits significantly from donor-funded procurement channels, with major partners including the Global Fund to Fight AIDS, Tuberculosis and Malaria, USAID through its supply chain programs (such as GHSC-PSM), UNICEF, and Gavi, the Vaccine Alliance, which collectively support procurement of a broad range of health commodities including HIV/AIDS and malaria diagnostics, vaccines, and essential medicines. These donor channels often operate through international competitive tendering and require WHO prequalification or SRA approval as eligibility criteria, creating a parallel procurement pathway alongside the national public system. Ghana has expressed policy interest in promoting local manufacturing and domestic production of health products, aligned with the Africa Medicines Manufacturing for Africa (AM4A) initiative and the African Union's Pharmaceutical Manufacturing Plan for Africa, with emerging preferences for locally manufactured products in public tenders where quality and supply capacity can be demonstrated.