Clinical Trials (Orthodox Medicines): Digital CTF1 Module & Pilot Briefing
2026-03-10 14:00 - 15:30 (Africa/Johannesburg) | 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 engage with the team.

Agenda included:

Project Lifecycle Update
Demonstration of the Digital CTF1 Application Process
Overview of the Upcoming Pilot

Watch Recording

SAHPRA’s Regulatory Technical Forum (RTF) Virtual Meeting – March 2026
2026-03-12 09:00 - 12:00
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
Veterinary Medicines presentations
Inspectorate Updates
New Registrations, Variations & Reliance

Recording

Orientation Webinar on the SAHPRA Portal for New Clinical Trials Application Users
2026-03-26 14:30 - 16:00
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 Covered:

Orientation on registering an account on the SAHPRA Portal
How to create an application
How to create the Sales Order Form
How to upload proof of payment
How to view your Accounts Notification Centre
How to respond to queries from the SAHPRA unit
How to access your application outcome

Recording:

Industry Meeting to receive input from applicants on the functionality of the Digital CTF1 Application Module
2026-04-13 12:00 - 14:00
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 to share practical experiences, challenges, and recommendations related to the use of the SAHPRA Portal, thereby supporting continuous system improvement and enhanced user experience.

Proposed Discussion / Agenda Items:

Feedback on registering an account on the SAHPRA Portal
Feedback on how to create an application
Feedback on how to create the Sales Order Form
Feedback on how to upload proof of payment
Feedback on accessing and using the Accounts Notification Centre
Feedback on how to respond to queries from the relevant SAHPRA unit
Feedback on how to access application outcomes

Register here: https://bit.ly/4ceXW1i

Webinar on AEFI Reporting & Launch of VigiMobile App for HCPs
2026-04-16 14:00 - 15:00, 2026-04-20 14:00 - 15:00
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 timely and accurate reporting by healthcare professionals.
To strengthen AEFI reporting, SAHPRA, in collaboration with the National Department of Health, has introduced electronic submission of AEFI reports. This Webinar will assist healthcare professionals to understand basic concepts of AEFI and reinforce the importance of reporting both non-serious and serious AEFIs.
The Webinar addressed the following topics:

Understanding Basic Concepts and Reporting of Adverse Events Following Immunisation
Demonstration of AEFI reporting using the VigiMobile App

Recording:

Industry Meeting on Adverse Event Reporting for Medical Devices (including IVDs)
2026-04-22 10:00 - 12:00
The South African Health Products Regulatory Authority (SAHPRA) hosted an engagement session focused on training and guidance regarding SAHPRA’s requirements for Adverse Event reporting.

The purpose of the engagement was to enhance industry understanding and facilitate the effective implementation of Regulation 17 of the Regulations Relating to Medical Devices, including In Vitro Diagnostic Medical Devices (IVDs). This initiative supported regulatory compliance, strengthened post‑market surveillance activities, and promoted the safety, performance, and quality of medical devices placed on the South African market.

Recording

Industry Webinar on Upcoming Medical Devices Voluntary Feasibility Study - Phase Two
2026-05-08 11:00 - 13:00
The South African Health Products Regulatory Authority (SAHPRA) hosted a workshop on the Medical Devices Voluntary Product Registration Feasibility Study – Phase Two.

The purpose of the workshop was to engage stakeholders and discuss the Expression of Interest (EOI) process for participation in the voluntary Phase Two product registration feasibility study for medical devices.

This engagement formed part of SAHPRA’s ongoing efforts to strengthen regulatory systems, optimise registration processes, and enhance transparency in the regulation of medical devices in South Africa.

Recording

Presentations
MD Registration Feasibility Study Phase 2

Launch of the Prescription-Only Medicines Section – SAHPRA Online Medicines Directory
2026-05-20 10:00 - 11:00
The South African Health Products Regulatory Authority (SAHPRA) cordially invites you to attend the official online launch of the Prescription-Only Medicines (Rx) Section of the SAHPRA Online Medicines Directory.

SAHPRA successfully launched the Over-the-Counter (OTC) Online Medicines Directory in June 2022 as the first phase of this initiative.

The Online Medicines Directory is designed to provide patients, consumers, and healthcare providers with a single, trusted and authoritative source of information on all medicines approved by SAHPRA.

The launch of the Rx section marks a significant milestone in expanding access to comprehensive, reliable medicine information in South Africa.
Register here: https://bit.ly/4fgcyAq

Webinar on Medical Device Licencing & Compliance
2026-05-22 10:00 - 12:00
The South African Health Products Regulatory Authority (SAHPRA) cordially invites you to attend a stakeholder engagement webinar focused on medical device licensing and compliance requirements.

The purpose of this engagement is to provide targeted training to industry stakeholders on SAHPRA’s regulatory requirements, supporting improved compliance and effective implementation across the sector.

Discussion topics will include:

Application processes, including updates to relevant forms
Progress on ISO 13485 certification post-implementation
Annual retention fees
Port of entry requirements

Stakeholders are encouraged to attend and actively participate in this important session.

Should you require further information, please do not hesitate to contact us.

We look forward to your participation.

Register here
