SAHPRA Tag

The South African Health Products Regulatory Authority (SAHPRA) invites industry stakeholders to attend an information session on Traceability Implementation: Digital Systems, Data Exchanges and API Interfaces.   This session will provide stakeholders with an overview of the digital systems and interoperability requirements that support product traceability across...

The South African Health Products Regulatory Authority (SAHPRA) hosted a webinar on the launch of new modules within the SAHPRA Portal. The webinar provided an overview of newly introduced portal functionalities designed to enhance regulatory processes, improve data quality, and support digital transformation initiatives. Stakeholders received...

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...