Archive

This document provides an overview of the medicines' safety regulatory decisions made by the South African Health Products Regulatory Authority (SAHPRA) during Jan - Mar 2025. This includes decisions where safety concerns were reviewed and concluded, as well as those safety concerns that remain unresolved...

The aim of this newsletter is to disseminate regulatory information on post-marketing surveillance and pharmacovigilance activities rendered by SAHPRA, which includes responsibilities of the SAHPRA Pharmacovigilance unit, reporting tools and pharmacovigilance systems in the country....

This document provides an overview of the medicines safety regulatory decisions made by the South African Health Products Regulatory Authority (SAHPRA) during January – March 2024. This includes decisions where safety concerns were reviewed and concluded, as well as those safety concerns that remain unresolved...

This document provides an overview of the medicines safety regulatory decisions made by the South African Health Products Regulatory Authority (SAHPRA) during October – December 2023. This includes decisions where safety concerns were reviewed and concluded, as well as those safety concerns that remain unresolved...

This document provides an overview of the medicines safety regulatory decisions made by the South African Health Products Regulatory Authority (SAHPRA) during October – December 2023. This includes decisions where safety concerns were reviewed and concluded, as well as those safety concerns that remain unresolved...

The purpose of the form is to guide SAHPRA’s holders of certificates of registration about the details required and elements to be considered in the process of signal notification and follow-up. This form should be used to notify signals and Follow-Up information on signals according...