This document serves as a guideline for those reporting adverse drug reactions. It represents the South African Health Products Regulatory Authority’s (SAHPRA)’s current thinking on the safety, quality and efficacy of medicines. The Authority reserves the right to request any additional information to establish the...
This document is intended to provide communication to all Holders of Certificates of Registration (HCRs)/ Applicants about the mandatory submission of Post-marketing Adverse Event (AE) reports for human medicines through Industry eReporting VigiFlow module. The submission of post-marketing AE reports for human medicines is applicable...
Janssen Pharmaceutica (Pty) Ltd, in collaboration with the South African Health Products Regulatory Authority (SAHPRA) would like to inform you of the risk of neurodevelopment disorders (NDDs) associated with topiramate use in pregnancy....
The following pharmaceutical companies, GlaxoSmithKline (GSK) South Africa, Ranbaxy Pharmaceuticals (Pty) Ltd South Africa, Pharma Dynamics (Pty) Ltd, Unicorn Pharmaceuticals (Pty) Ltd, Cipla Medpro (Pty) Ltd, Hetero Drugs South Africa (Pty) Ltd, Dr Reddy’s Laboratories (Pty) Ltd, in collaboration with the South African Health Products...
The following pharmaceutical companies, Equity Pharmaceuticals (Pty) Ltd, Pharmacare Ltd t/a Aspen Pharmacare and Adcock Ingram Limited in collaboration with the South African Health Products Regulatory Authority (SAHPRA), would like to inform you about the potential risk of drug reaction with eosinophilia and systemic symptoms...
This document provides an overview of the medicines' safety regulatory decisions made by the South African Health Products Regulatory Authority (SAHPRA) during Jul - Sep 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 Oct - Dec 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 Apr - Jun 2025. 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 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....
