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10 Nov

Posted at 11:37h in

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...

10 Nov

Posted at 11:34h in

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...

03 Oct

Posted at 10:08h in

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...

25 Sep

Posted at 13:18h in

This is the second edition of the South African Health Products Regulatory Authority’s (SAHPRA’s) ReguLetter that will provide a quarterly overview of regulatory decisions relating to safety alerts, recalls and rapid alerts. This edition will provide information for the period July to September 2025....

09 Sep

Posted at 14:08h in

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...

14 Aug

Posted at 12:03h in

Welcome to the first edition of the South African Health Products Regulatory Authority’s (SAHPRA’s) ReguLetter that will provide a quarterly overview of regulatory decisions relating to safety alerts, recalls, and rapid alerts. This edition will provide information for the period April to June 2025....