Ghana

The Food and Drugs Authority (FDA) Ghana is the primary national regulatory authority responsible for the registration, control, and regulation 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 consolidated and replaced earlier legislation to provide a modernised framework for product regulation. All health products intended for sale or use in Ghana must be registered with the FDA prior to market entry. The registration process involves submission of a product dossier, technical review, and where applicable, facility inspection. The FDA also enforces post-market surveillance obligations and has the authority to suspend or revoke product licences for non-compliance.

Applicants are required to appoint a local authorised representative or registered importer to facilitate submissions and serve as the in-country point of contact for regulatory purposes. Ghana accepts dossiers formatted according to the Common Technical Document (CTD) standard and aligns with guidelines from the World Health Organization (WHO) Prequalification Programme, the International Council for Harmonisation (ICH), and the African Medicines Regulatory Harmonisation (AMRH) initiative. Ghana is a member of the African Union's African Medicines Agency (AMA) framework and has committed to progressive harmonisation of its regulatory standards with regional counterparts through the Economic Community of West African States (ECOWAS) regulatory convergence programme. Recent reforms have included digitisation of submission portals, introduction of expedited review pathways for WHO-prequalified or stringent regulatory authority (SRA)-approved products, and strengthened post-market surveillance mechanisms.

Public procurement of health products in Ghana is governed primarily by the Public Procurement Authority (PPA) under the Public Procurement Act, 2003 (Act 663) as amended by Act 914 (2016). The Ministry of Health (MOH) sets national health commodity policies and coordinates procurement strategy, while the Ghana Health Service (GHS) manages the delivery of health services at the national and sub-national levels. The central procurement agent for public sector health commodities is the Public Procurement Authority working in conjunction with the Ghana Health Service and relevant technical divisions of the MOH. The National Insurance Authority (NHIA), which administers the National Health Insurance Scheme (NHIS), also plays a significant role in determining which health products are reimbursable, thereby influencing demand and procurement volumes across public facilities. Tender processes for large-volume procurements are conducted through open competitive bidding, with contracts awarded to suppliers meeting technical, regulatory, and financial criteria.

Ghana's health sector benefits substantially from donor-funded procurement channels. Major international partners including the Global Fund to Fight AIDS, Tuberculosis and Malaria, USAID through the GHSC-PSM mechanism, UNICEF, and Gavi, the Vaccine Alliance, finance and co-ordinate the procurement of significant volumes of health commodities, particularly for HIV, malaria, tuberculosis, reproductive health, and immunisation programmes. These donor-funded procurements typically require products to hold WHO prequalification or approval from an SRA recognised by WHO, and are often channelled through international procurement agents operating in-country. The Government of Ghana has articulated a local manufacturing preference policy aligned with the Africa CDC's Partnerships for African Vaccine Manufacturing (PAVM) initiative and broader strategies to develop domestic pharmaceutical and medical device manufacturing capacity. Local manufacturers may receive preferential treatment in public tenders where applicable, and Ghana's Industrial Development Fund supports investment in local production, though implementation of these preferences remains an evolving area of policy.