The South African Health Products Regulatory Authority (SAHPRA) has a mandate to oversee the safety, efficacy and quality of all medicines registered in South Africa, including vaccines....
Pfizer South Africa, in collaboration with the South African Health Products Regulatory Authority (SAHPRA) wish to inform you of the warning regarding rare cases of myocarditis and pericarditis reports that were noted following the use of COVID-19 mRNA vaccines, including Comirnaty® (Covid- 19 mRNA vaccine)....
Novartis, as directed by the South African Health Products Regulatory Authority (SAHPRA), would like to inform you about the requirement to discontinue treatment with Vsiqq® in patients who develop retinal vasculitis and/or retinal vascular occlusion. Retinal vasculitis and retinal vascular occlusion are immune-mediated events, which...
The following holders of certificates of registration (HCRs), Aspen Pharmacare, GlaxoSmithKline (Pty) Ltd and Glenmark Pharmaceuticals South Africa (Pty) Ltd, in collaboration with the South African Health Products Regulatory Authority (SAHPRA), wish to draw your attention to the following important safety information associated with topical...
For over a decade, ADR reports have been submitted to the National Adverse Drug Events Monitoring Centre (NADEMC) via fax. These reports were previously captured on the ADRI database. The ADRI database restricted electronic reporting by both applicants and healthcare professionals, and direct uploading of...
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 safety regulatory decisions taken by SAHPRA on the safety concerns discussed during January – March 2022. This includes a summary of regulatory decisions, where safety concerns were reviewed and concluded, and those safety concerns that are not concluded...
This document serves as a guideline to those reporting adverse drug reactions. It represents the South African Health Products Regulatory Authority’s current thinking on the safety, quality and efficacy of medicines. The Authority reserves the right to request any additional information to establish the safety,...
This document provides guidance to the applicants/holders of Certificate of Registration on the pharmacovigilance system requirements. It is meant to facilitate compliance by applicants/HCRs with the regulatory authority on pharmacovigilance requirements....
This document has been prepared to serve as a guideline to those involved in the conduct of Pharmacovigilance inspections. It is meant to facilitate compliance with Good Pharmacovigilance Practice relating to the conduct and monitoring of Pharmacovigilance inspections. It is not intended as an exclusive...