South Africa

Executive summary

South Africa is the largest pharmaceutical market in Sub-Saharan Africa and is regulated by the South African Health Products Regulatory Authority (SAHPRA), an autonomous statutory body established in 2018 as the successor to the Medicines Control Council (MCC). SAHPRA operates under the Medicines and Related Substances Act 101 of 1965 (as amended) and regulates medicines, complementary medicines, medical devices, IVDs, blood products, and clinical trials. SAHPRA's transformation from the legacy MCC has dramatically reduced backlog: the Backlog Clearance Programme (started 2019) cleared >16,000 legacy applications by 2023, and SAHPRA now operates risk-based queues with target timelines of 365 days (full review) and 180 days (reliance). SAHPRA is a WHO-Listed Authority (WHO-LA) for vaccines and is a PIC/S member applicant. South Africa accepts ICH-CTD/eCTD and operates a formal reliance pathway recognising assessments from FDA, EMA, MHRA, Health Canada, TGA, and WHO PQ. Pricing is regulated via the Single Exit Price (SEP) system — the only price at which a medicine may be sold in the private sector, set annually by the Minister of Health. The National Health Insurance (NHI) Act 2023 will progressively expand public reimbursement; CONITEC-equivalent HTA via the National Essential Medicines List Committee (NEMLC) drives public-sector listings.