Stakeholders are hereby invited to provide further comments to the draft SAHPRA’s Broad-Based Black Economic Empowerment Policy for issuance of new and the renewal of licences as per section 22C of the Medicines Act. To expedite the process, the stakeholders are requested not repeat the...
This document is intended to provide communication to applicants on system updates regarding the Regulatory Information Management System (RIMS) Portal and the Digital Variations Portal (DVP). SAHPRA’s digital transformation has progressed as planned with submissions via the sFTP for new product applications, all variations, and renewals...
GlaxoSmithKline (GSK) South Africa, in collaboration with SAHPRA, would like to inform healthcare professionals about the risk of drug reaction with eosinophilia and systemic symptoms (DRESS) associated with the use of aciclovir and valaciclovir-containing medicines....
In collaboration with the South African Health Products Regulatory Authority (SAHPRA), Dr. Reddy’s Laboratories (Pty) Ltd would like to draw your attention to the recommended calculations of contraception duration after completion of therapy with genotoxic anticancer medicines (including potential genotoxic metabolites)....
Eisai Pharmaceuticals Africa (Pty) Ltd, in collaboration with the South African Health Products Regulatory Authority (SAHPRA) would like to inform you about the recommended calculations of contraception duration after completion of therapy with Halaven® (eribulin mesylate), including its potential genotoxic metabolites....
PharmaDynamics and other collaborators, would like to warn healthcare professionals about the risk of intrathecal administration of intravenous (IV) tranexamic acid, which may result in serious lifethreatening injuries, including seizures, cardiac arrhythmias, paraplegia, permanent neurological injury, and death. There have been reports of IV tranexamic...
Acino Pharma (Pty) Ltd, Adcock Ingram Limited, Aspen Pharmacare, Cipla Medpro, Ranbaxy Pharmaceuticals (Pty) Ltd and Pharmaceutical Contractors (Pty) Ltd, in collaboration with the South African Health Products Regulatory Authority (SAHPRA), would like to draw your attention to the risk of posterior reversible encephalopathy syndrome...
The DHCP letter initiated by Roche is intended to inform healthcare professionals about deregistration of approved indications for Gavreto® (pralsetinib) and removal from the South African pharmaceutical market....
The document, ZA-SAHPRA CTD eSubmission Specification June 2024, v3.0 is out for applicant comment with a response deadline of Wednesday, 03 July 2024. Download the Document for Comments here. Comments deadline: 03 July 2024...
This document is intended to provide contact details for communicating reportable adverse events, as per Guideline SAHPGL-MD-03, as well as contact details for any Recalls and Market actions for medical devices (including IVDs). Reportable adverse events reports must be emailed to mdvigilance@sahpra.org.za and copy (cc) Puseletso.Mogano@sahpra.org.za...