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
The South African Health Products Regulatory Authority (SAHPRA) hosted the 2nd webinar in our Codeine Care Initiative (CCI) series. Our first module had focused on the holistic management of pain, cough, and colds. This 2nd webinar focused on a review of legislation around codeine-containing medicines....
The South African Health Products Regulatory Authority (SAHPRA) hosted the second industry workshop in a series of informative workshops on eCTD. This webinar introduced you to Specification 3.1. The discussion points were: Changes from Specification 3.0 Envelopes Headings Lifecycle maintenance Validations Baselines Closing sequences Presentation...
The South African Health Products Regulatory Authority (SAHPRA) hosted industry stakeholders at the Regulatory Technical Forum (RTF) Meeting. Areas discussed on the agenda included: Comments on the newly established SAHPRA Regulatory Technical Forum EOI on model dossiers for training BAU applications and variations Medicines (Allopathic)...
The South African Health Products Regulatory Authority (SAHPRA) recently hosted the 3rd webinar in our Codeine Care Initiative (CCI) series, focusing on Patient Safety – Codeine’s Place in Pharmaceutical Care. Following our first module, which centred on holistic management for pain, cough, and colds, and...
