SAHPRA (South Africa)

The South African Health Products Regulatory Authority (SAHPRA) is South Africa's national regulator for human and veterinary medicines, biologicals, vaccines, medical devices, IVDs, complementary and alternative medicines, cannabis for medicinal use, blood products and radiation-emitting devices. SAHPRA became operational on 1 February 2018 as an independent Schedule 3A public entity, replacing the Medicines Control Council (MCC) which had operated inside the National Department of Health. The governing legislation is the Medicines and Related Substances Act 101 of 1965 (as amended, most recently by Act 14 of 2015) together with the Hazardous Substances Act 15 of 1973 for radiation-emitting devices.

South Africa reached WHO Maturity Level 3 for medicines regulation in 2022. SAHPRA operates reliance pathways — recognised regulatory authority (RRA) route — for approvals from FDA, EMA, MHRA, Health Canada, TGA, Swissmedic and PMDA, and runs a CTD-aligned dossier review for generics and biosimilars. Medical devices follow a risk-classified pathway aligned to IMDRF principles, licensed under the Medical Devices and IVD regulations. Complementary medicines are being registered category-by-category under a phased call-up.

GMP inspections of overseas manufacturers are risk-based; PIC/S / EU / FDA GMP certificates support desk review, while biologicals, sterile products and high-risk devices attract on-site inspection. SAHPRA is a PIC/S member since 2007 (inherited from MCC), aligning its inspection regime with international norms. V5 Ultimate maps directly onto SAHPRA expectations — bound e-signatures, ALCOA+ batch records, deviation/CAPA workflow, and a per-country dossier pack — with the paired guide at /glossary/south-africa-sahpra.