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...
The South African Health Products Regulatory Authority (SAHPRA) recently hosted its Regulatory Technical Forum (RTF) Meeting, bringing together key industry stakeholders to discuss regulatory updates. Areas of discussion on the agenda included: BAU Applications and Variations Medicines (Allopathic) Veterinary Medicines Complementary Medicines Inspectorate and Regulatory...
The South African Health Products Regulatory Authority (SAHPRA) is launching an online applications platform. This platform hosted several application processes, which are enabled across different phases in the overall implementation of their engagement platform. What was covered?: How does the portal work How to submit...
The South African Health Products Regulatory Authority (SAHPRA) hosted an educational and informative webinar to provide broader awareness of the SAHPRA Engagement Portal. This webinar session focused on the submission of Section 21 applications for Category A Medicines (also known as Orthodox or allopathic medicines)....
The South African Health Products Regulatory Authority (SAHPRA) became aware of processing issues after the launch of the SAHPRA Engagement Portal on 01 April 2025. This webinar aimed to address processing issues around system failures. Applicants are encouraged to attend to address issues regarding: Assistance...
The South African Health Products Regulatory Authority (SAHPRA) has become aware of processing issues after the launch of the SAHPRA Engagement Portal on 01 April 2025. This webinar aims to address processing issues around system failures. Applicants are encouraged to attend to address issues regarding:...
