CCI Webinar Series: Module 2 | Legislative Review

Hybrid

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....

Industry Workshop: eCTD’s Introduction of Specification 3.1

Hybrid

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...

SAHPRA’s Regulatory Technical Forum (RTF) Virtual Meeting

Virtual

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)...

Industry Workshop: Specification 3.1 Processes

Virtual

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...

SAHPRA’s Regulatory Technical Forum (RTF) Virtual Meeting

Virtual

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...

Complementary Medicines’ Stakeholder Engagement Hybrid Workshop

Virtual

The South African Health Product Regulatory Authority (SAHPRA) Complementary Medicines’ (CMs’) Hybrid Workshop successfully took place, offering attendees the option to participate either in person or via a virtual platform. Key areas discussed during the workshop included: SAHPRA responded to the 21 questions regarding Complementary...

Industry Stakeholder Engagement | Medical Devices Unit

Virtual

The Medical Devices Unit of the South African Health Products Regulatory Authority (SAHPRA) hosted a consultative meeting with Industry. The meeting aimed to communicate updates, ensure compliance with legislative requirements, discuss improvements to the application process, and enhance overall client service and relations. Areas of...