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...
SAHPRA requests electronic submission of the latest PSMF by 12 November 2025, including PV staffing details and a list of registered and marketed products. Submit via email to GVP@sahpra.org.za with the specified subject line....
Adcock Ingram Limited, in collaboration with the South African Health Products Regulatory Authority (SAHPRA), would like to inform you of the amended product labelling for Corenza-C® Effervescent Tablets to align with the recommended contraindicated use of aspirin in children under the age of 12 years...
The document is a Dear Healthcare Professional (DHCP) letter informing healthcare professionals about the risk of neurodevelopment disorders in children born to fathers exposed valproate valproate-containing medicines three months before conception....
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...
This document provides an overview of the safety regulatory decisions taken by the South African Health Products Regulatory Authority (SAHPRA) during January – March 2023. This includes a summary of regulatory decisions, where safety concerns were reviewed and concluded, and those safety concerns that are...
The South African Health Products Regulatory Authority (SAHPRA) would like to invite you to a Medical Dictionary for Regulatory Activities (MedDRA) training. MedDRA is an international standardised medical terminology developed to facilitate the sharing of regulatory information for medical products used by humans. This communication...