South Africa

The South African Health Products Regulatory Authority (SAHPRA) is the primary national regulatory body responsible for the evaluation, registration, and post-market surveillance of health products in South Africa, including medicines, medical devices, in vitro diagnostics, and complementary medicines. SAHPRA was established as an independent juristic entity under the South African Health Products Regulatory Authority Act (Act 11 of 2017), which amended the Medicines and Related Substances Act (Act 101 of 1965). All health products must be registered with SAHPRA before they may be marketed, sold, or distributed in South Africa, and applicants must submit a formal application dossier demonstrating safety, quality, and efficacy or performance. Unregistered products may only be made available under specific exemptions, such as Section 21 authorisation for unregistered medicines in exceptional circumstances.

SAHPRA accepts dossiers compiled in accordance with the Common Technical Document (CTD) format for pharmaceuticals and aligned international standards for medical devices and diagnostics, including technical files consistent with Global Harmonization Task Force (GHTF) and International Medical Device Regulators Forum (IMDRF) guidance. Applicants are required to appoint a local responsible person or South African-registered entity to act as the licence holder and regulatory contact. SAHPRA has undertaken significant reform efforts in recent years to address registration backlogs, introducing a risk-based review pathway and a reliance framework that allows expedited evaluation based on approvals from recognised stringent regulatory authorities (SRAs) such as the EMA, US FDA, Health Canada, and TGA. Medical devices and IVDs are regulated under the Medical Devices and IVDs Regulations (2022), which introduced a formal classification and registration system for these product categories, replacing the previous voluntary notification scheme.

Public sector procurement of health products in South Africa is primarily coordinated through the National Department of Health (NDoH) and the provincial departments of health, which together account for the majority of public health expenditure. The central procurement mechanism is the National Health Laboratory Service (NHLS) for diagnostic and laboratory products, while pharmaceutical and medical device procurement is managed through the NDoH's Chief Directorate: Affordable Medicines, which negotiates national contracts and tenders. The State Tender Board framework and Treasury Regulations govern public procurement processes, with contracts awarded through the Central Supplier Database (CSD). Provincial departments retain significant autonomy and may procure independently via their own tender processes for products not covered by national contracts, creating a multi-tiered procurement landscape that suppliers must navigate across all nine provinces. Preference is given to suppliers that comply with Broad-Based Black Economic Empowerment (B-BBEE) requirements under the Preferential Procurement Policy Framework Act (PPPFA), incentivising local partnerships and transformation-aligned supply chains.

The private sector in South Africa is well developed and represents a substantial share of total health expenditure, with procurement largely driven by private hospital groups such as Mediclinic, Netcare, and Life Healthcare, as well as pharmacy chains including Clicks and Dis-Chem. Medical aid schemes, regulated by the Council for Medical Schemes (CMS), influence formulary and reimbursement decisions in the private sector. South Africa also benefits from significant donor-funded procurement channels, particularly for HIV, tuberculosis, and malaria programmes. The Global Fund to Fight AIDS, Tuberculosis and Malaria, PEPFAR (administered via USAID), and UNITAID provide substantial funding for medicines, diagnostics, and health commodities, often procured through international procurement agents such as the Global Drug Facility (GDF) and UNICEF Supply Division. Local manufacturing is actively encouraged through the NDoH's Pharmaceutical Manufacturing Industry Strategy and the African Union's Partnerships for African Vaccine Manufacturing (PAVM) framework, with South Africa positioning itself as a regional hub for pharmaceutical and vaccine production on the continent.