The South African Health Products Regulatory Authority (SAHPRA) is hosting an Industry webinar for updates on the Regulatory Information Management System (RIMS) roll-out. What to expect? SAHPRA will start with cut-over activities during the course of March 2024 and the implementation process on 02 April 2024....
The South African Health Products Regulatory Authority (SAHPRA), in collaboration with the South African National Accreditation System (SANAS), hosted a Conformity Assessment Bodies (CABs) Virtual Meeting. What was discussed? Extension of scope of practice to include technical dossier review SANAS Accreditation process SAHPRA requirements and future...
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....
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...
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 3rdsession of our industry webinar focused on the Regulatory Information Management System (RIMS) roll-out updates. Watch Recording:
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...
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...
The South African Health Products Regulatory Authority (SAHPRA) hosted an industry workshop to empower and educate you on the FAQs & Common Deficiencies for APIMF Submission. The workshop provided information to the Industry Stakeholders and APIMF holders on the SAHPRA’s current APIMF submission procedure. In...
A Consultative meeting with the industry to communicate updates, and improve the application process, as well as the overall services and relations. Date: 28 June 2023 Time: 9h00 to 12h30 Watch Recording
The South African Health Products Regulatory Authority (SAHPRA) recently hosted the launch webinar for our Codeine Care Initiative (CCI) series. This inaugural webinar focused on the holistic management of pain, cough, and colds. What was covered: Insightful information on pain, cold, and cough management. An...
The South African Health Products Regulatory Authority (SAHPRA) hosted an informative workshop on the upcoming eCTD Specification 3.1 and the launch of the new Application Submission Portal. This was the first of three workshops. Presentations Download Presentation Watch Recording
