SAHPRA Tag

20 August 2026 The South African Health Products Regulatory Authority (SAHPRA) wishes to remind healthcare professionals of the risk of angioedema during treatment with angiotensin-converting enzyme (ACE) inhibitors (e.g. captopril, enalapril, lisinopril, perindopril, quinapril, ramipril, trandolapril). Healthcare professionals are reminded that ACE inhibitor treatment should be...

The South African Health Products Regulatory Authority (SAHPRA) remained committed to strengthening the regulation of health products and aligning South Africa's regulatory framework with international best practices. Following the initial stakeholder engagement on the mandatory Import Authorisation System for health products, SAHPRA acknowledged the valuable feedback...

Pretoria, 16 August 2026 – The South African Health Products Regulatory Authority (SAHPRA) has initiated the recall of four batches of Enalapril 10mg Arya, a medicine commonly used to treat high blood pressure (hypertension), following the identification of out-of-specification results during post-marketing surveillance inspections. The recall...

The South African Health Products Regulatory Authority (SAHPRA) hosted a webinar on Strengthening Regulatory Oversight Through Improved Manufacturer Visibility. The webinar provided an overview of SAHPRA's initiatives aimed at enhancing regulatory oversight through improved visibility of manufacturers and associated suppliers across the supply chain. Stakeholders...

The South African Health Products Regulatory Authority (SAHPRA) invited industry stakeholders to attend a Webinar on the Updates to the Variations Guideline and Codes.   The webinar aimed to inform stakeholders of the updates to the Variations Guideline and associated codes, and to provide guidance on...

Pretoria, 08 July 2026 – The South African Pharmacy Council (SAPC), Health Professions Council of South Africa (HPCSA) and the South African Health Products Regulatory Authority (SAHPRA) hereby warn the public, pharmacies and dispensing medical practitioners against any continued use, prescription and/or dispensing of iDEXIS...

The South African Health Products Regulatory Authority (SAHPRA) hosted a webinar on the Introduction of Import Authorisation Requirements for Health Products Importers.   As part of aligning with WHO Global Benchmarking Tool (GBT) Maturity Level 3 (ML3), the SAHPRA is introducing a mandatory Import Authorisation System for all health...