Communication to Industry – Summary of Medicine Safety Regulatory Decisions (PV04-2023/24)

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 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). Safety decisions concerning the amendment of professional information and patient information leaflets (PI/PIL) are submitted to the Clinical Evaluations unit to review and ensure appropriate implementation and amendments thereof.