Pretoria, 29 May 2024 –The South African Health Products Regulatory Authority (SAHPRA) has attained its ISO 9001:2015 certification following a rigorous audit by the South African Bureau of Standards (SABS), a milestone that serves as a testament to the implementation of an effective and robust...
The South African Health Products Regulatory Authority (SAHPRA) hosted a Hybrid Stakeholder Engagement Meeting. The meeting was held in person and via our virtual platform. Areas of discussion on the agenda included: SAHPRA’s strategy to support local manufacturing of vaccines as per African Union Agenda 2063 ...
Pretoria, South Africa, 28 April 2024 – The South African Health Products Regulatory Authority (SAHPRA) and the Botswana Medicines Regulatory Authority (BoMRA) have signed a memorandum of understanding (MoU) that will see the two regulators partner on various areas to improve access to new medicines...
South African Health Products Regulatory Authority (SAHPRA) hosted the Inaugural Meeting of the Regulatory Technical Forum (RTF). Areas of discussion on the agenda included: Veterinary Medicines Complementary Medicines Pharmacovigilance Medical Devices and IVDs Allopathic Medicines Radiation Control Legislation/Guidelines for Comment or Implementation Date: 16 May 2024 Time: 09:00...
The South African Health Products Regulatory Authority (SAHPRA) hosted the 3rdsession of our industry webinar focused on the Regulatory Information Management System (RIMS) roll-out updates. Watch Recording: ...
Pretoria, 13 April 2024 – On 10 April 2024, the South African Health Products Regulatory Authority (SAHPRA) received a report from the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) regarding the detection of high levels of diethylene glycol in a batch...
Kigali - Rwanda, 12 April 2024 – The South African Health Products Regulatory Authority (SAHPRA) has signed a Memorandum of Understanding (MoU) with the Rwanda Food and Drug Authority (Rwanda FDA). The MOU between SAHPRA and Rwanda FDA will allow the regulators to develop a cooperative...
The Medical Devices Unit of the South African Health Products Regulatory Authority (SAHPRA) hosted an awareness session on this unit’s medical device registration update on the upcoming voluntary feasibility study. Date: 19 April 2024 Time: 10:00 to 13:00 Download Presentation Download Feasibility Study Watch Recording: ...
The South African Health Products Regulatory Authority (SAHPRA) hosted the 2nd session of our industry webinar focused on the Regulatory Information Management System (RIMS) roll-out updates. The session was recorded and published on the SAHPRA website. A similar Update session will be held once the eSubmission specifications and guidelines...
The South African Health Products Regulatory Authority (SAHPRA) hosted an industry workshop to empower and educate you on the Authority’s requirements when submitting Risk Management Plans (RMPs). This workshop highlighted the importance of maintaining RMPs to ensure the safety of medicines, while also sharing requirements for compliance. Date: 11 April...
