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...
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 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) hosted the third industry workshop in a series of informative sessions around eCTD. This webinar focused on Specification 3.1 processes. The processes covered included: Baselines-Iterative TOA Splitting the eCTD Multiple applications (replicas, clones, and duplicates) Line Extensions...
The South African Health Products Regulatory Authority (SAHPRA) hosted the launch of the SAHPRA Engagement Portal. The expected outcomes: Overview Account administration Training Who attended? Industry stakeholders Presentation Download Presentation Watch Recording
The South African Health Products Regulatory Authority (SAHPRA) hosted industry stakeholders at the Regulatory Technical Forum (RTF) Meeting. Areas discussed on the agenda included: EOI on model dossiers for training BAU applications and variations Medicines (Allopathic) Veterinary Medicines Complementary Medicines Inspectorate and Regulatory Compliance Medical...
The South African Health Products Regulatory Authority (SAHPRA), in collaboration with the World Health Organization (WHO), recently hosted a webinar to introduce the WHO Pilot on the Implementation of the National Action Plan for combating substandard and falsified (SF) medical products in South Africa. The...
