• 2nd Session | Updates on Regulatory Information Management System (RIMS) Roll-Out

    Virtual

    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...

  • Industry Webinar on SAHPRA’s eCTD Specification 3.0

    Virtual

    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

  • Clinical Trials (Orthodox Medicines): Digital CTF1 Module & Pilot Briefing

    Virtual

    SAHPRA hosted a consultative meeting with industry stakeholders to share key updates on the development of the Digital CTF1 Application Module and to provide information regarding the planned pilot phase. The session included project progress updates, a system demonstration, and an opportunity for attendees to...

  • Orientation Webinar on the SAHPRA Portal for New Clinical Trials Application Users

    Virtual

    The South African Health Products Regulatory Authority (SAHPRA) hosted a follow-up webinar to guide applicants through key functions on the SAHPRA Portal related to Clinical Trials applications. This practical orientation session assisted users in navigating the system effectively and completing the required actions.   Topics...