Summary of Medicines Safety Regulatory Decisions

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 but are severe and serious in nature. SAHPRA decisions are actionable by the concerned stakeholders including applicants or holders of certificate of registration (HCRs). Safety decisions concerning amendment of a professional information are submitted to the Clinical Evaluations unit to review and ensure appropriate implementation of Professional Information and Patient Information Leaflet (PI/PIL) amendments.

2022 Jun