The South African Health Products Regulatory Authority (SAHPRA) hosted a Regulatory Technical Forum (RTF) Meeting. Areas of discussion on the agenda included: Veterinary Medicines Medical Devices & IVDs Complementary Medicines Medicines (Allopathic) Inspectorate Updates Inspectorate and Regulatory Compliance Legislation/Guidelines for Comment/Implementation IT Upgrade Recording
SAHPRA invited stakeholders to participate in the Medical Devices Product Registration Feasibility Study and related activities. The engagement focused on collaborating with industry stakeholders on regulatory matters concerning the preliminary report on product registration feasibility, as well as other communication and position documents published by...
SAHPRA hosted a Webinar focused on Industry Engagement regarding Reliance Applications. This session aimed to discuss the application of reliance in submissions and address any questions or concerns attendees may have related to this topic. Download Presentation Download Q&A's Recording:
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...
The South African Health Products Regulatory Authority (SAHPRA) hosted the Regulatory Technical Forum (RTF) Meeting. Areas of discussion on the agenda included: Veterinary Medicines Medical devices & IVDs Complementary medicines Medicines (Allopathic) Inspectorate Updates Inspectorate and Regulatory Compliance Legislation/Guidelines for Comment/Implementation IT Upgrade Presentations...
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...
The South African Health Products Regulatory Authority (SAHPRA) hereby invites industry stakeholders to a consultative meeting aimed at receiving updates and feedback from applicants on the functionality of the Digital CTF1 Application Module. The purpose of this engagement is to provide a platform for industry...
The South African Health Products Authority (SAHPRA) hosted a Webinar on reporting of Adverse Effects Following Immunisation (AEFI) and Launch of the VigiMobile App for Healthcare Professionals (HCPs). AEFI surveillance is a key component of the National Expanded Programme on Immunisation (EPI) and depends on...
The South African Health Products Authority (SAHPRA) will host a Webinar on reporting of Adverse Effects Following Immunisation (AEFI) and Launch of VigiMobile App for Healthcare Professionals (HCPs). AEFI surveillance is a key component of the National Expanded Programme on Immunisation (EPI) and depends on...
The South African Health Products Regulatory Authority (SAHPRA) invites industry stakeholders to a targeted stakeholder engagement session focused on training and guidance regarding SAHPRA’s requirements for Adverse Event reporting. The purpose of this engagement is to enhance industry understanding and effective implementation of Regulation 17...
