Safety Information and Updates

A health product is registered and made available in South Africa, based on the safety information obtained from clinical trials. Clinical trials provide information about many of the adverse events associated with a health product, but do not detect all possible adverse events. It is therefore important for the safety profile of a product to continuously be monitored throughout its life-cycle. SAHPRA, like other Regulatory Authorities around the globe, monitors the safety profiles of health products to ensure that their risk-benefit profiles remain favourable.

Through the product safety-monitoring program, SAHPRA issues safety updates to the public, consumers, healthcare professionals and industry about emerging safety information. Safety updates provide important safety information, recommendations or advice about health products. Reporting of adverse drug events by consumers, patients and health professionals provide important information for SAHPRA’s product safety monitoring program. To report and Adverse Drug Reaction, access our ADR reporting systems here.