Communication to Industry – Summary of Medicine Safety Regulatory Decisions

Communication to Industry – Summary of Medicine Safety Regulatory Decisions

This document provides an overview of the safety regulatory decisions taken by the South African Health Products Regulatory Authority (SAHPRA) during April to June 2023. This includes a summary of regulatory decisions, where safety concerns were reviewed and concluded, and those safety concerns that are not concluded but are severe and serious in nature. SAHPRA’s decisions are actionable by the concerned stakeholders including Applicants or holders of certificate of registration (HCRs).

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Document Number: PV05-2023/24
Version: 1
Date Updated: 27/05/2024
File Type: pdf
Category: Communication To the Public
Unit: Pharmacovigilance