SAHPRA

Webinar on Industry Engagement on Reliance Applications
2025-12-11 09:00 - 12:00 (Africa/Johannesburg) | Virtual
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.

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Recording:

Clinical Trials (Orthodox Medicines): Digital CTF1 Module & Pilot Briefing
2026-03-10 14:00 - 15:30
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

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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) held the official online launch of the Prescription-Only Medicines (Rx) Section of the SAHPRA Online Medicines Directory.
SAHPRA had previously successfully launched the Over-the-Counter (OTC) Online Medicines Directory in June 2022 as the first phase of this initiative.
The Online Medicines Directory was developed 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 marked a significant milestone in expanding access to comprehensive and reliable medicine information in South Africa.

Visit the Online Directory – medsinfo.sahpra.org.za

Recording

Webinar on Medical Device Licencing & Compliance
2026-05-22 10:00 - 12:00
The South African Health Products Regulatory Authority (SAHPRA) hosted a stakeholder engagement webinar focused on medical device licensing and compliance requirements.
The purpose of the engagement was to provide targeted training to industry stakeholders on SAHPRA’s regulatory requirements, supporting improved compliance and effective implementation across the sector.

Recording

SAHPRA’s Regulatory Technical Forum (RTF) Virtual Meeting – June 2026
2026-06-22 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

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Recording

Webinar on Import Authorisation Requirements for Health Products Importers
2026-06-29 13:00 - 15:00
The South African Health Products Regulatory Authority (SAHPRA) hosted a webinar on the Introduction of Import Authorisation Requirements for Health Products Importers.

As part of aligning with WHO Global Benchmarking Tool (GBT) Maturity Level 3 (ML3), the SAHPRA is introducing a mandatory Import Authorisation System for all health product importers, with a pilot phase commencing 1 September 2026. This system aims to strengthen regulatory oversight, improve product traceability, and safeguard public health.

Key Discussion Areas

WHO GBT ML3 overview
Scope of affected products and importers
Application and approval process
Fees and payment modalities
Implementation timeline and FAQs

Pre-Import Authorisation presentation

Recording

Industry Webinar on Updates to the Variations Guideline and Codes
2026-07-23 09:00 - 23:30
The South African Health Products Regulatory Authority (SAHPRA) invited industry stakeholders to attend a Webinar on the Updates to the Variations Guideline and Codes.

The webinar aimed to inform stakeholders of the updates to the Variations Guideline and associated codes, and to provide guidance on the technical changes contained within the revised guideline.

What was covered:

A brief introduction to the updated Variations Guideline.
Presentations by the respective units, guiding industry stakeholders through the technical changes within their sections of the guideline

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Recording

Updates on the Regulation of Advertising of Health Products Webinar
2026-07-28 15:00 - 16:00
The South African Health Products Regulatory Authority (SAHPRA) hosted a webinar on updates regarding the regulation of advertising of health products. As part of its ongoing efforts to strengthen regulatory oversight and align with international best practices, SAHPRA outlined its enhanced approach to regulating the advertising and promotion of medicines and medical devices. The webinar provided stakeholders with an overview of current and planned initiatives, including increased monitoring of advertising and promotional material, potential regulatory developments, and opportunities for industry engagement and participation.

Presentation by Daphney Fafudi

Recording

Webinar on Strengthening Regulatory Oversight Through Improved Manufacturer Visibility
2026-07-29 15:00 - 17:00
The South African Health Products Regulatory Authority (SAHPRA) hosted a webinar on Strengthening Regulatory Oversight Through Improved Manufacturer Visibility. The webinar provided an overview of SAHPRA’s initiatives aimed at enhancing regulatory oversight through improved visibility of manufacturers and associated suppliers across the supply chain. Stakeholders were informed of new data collection requirements, regulatory processes, and expectations that support risk-based oversight, inspection planning, and compliance monitoring.

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Recording

SAHPRA's Industry Consultation on e-Reporting VigiFlow Platform
2026-08-04 14:00 - 16:00
The South African Health Products Regulatory Authority (SAHPRA) hosted a webinar on Strengthening Regulatory Oversight Through Improved Manufacturer Visibility.

The webinar provided an overview of SAHPRA’s initiatives aimed at enhancing regulatory oversight through improved visibility of manufacturers and associated suppliers across the supply chain. Stakeholders were informed of new data collection requirements, regulatory processes, and expectations that support risk-based oversight, inspection planning, and compliance monitoring.

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Recording:
