Session 2 | SAHPRA Engagement Portal Emergency Webinar to Address Processing Issues
2025-04-09 14:00 - 16:00 (Africa/Johannesburg) | Virtual
The South African Health Products Regulatory Authority (SAHPRA) has become aware of processing issues after the launch of the SAHPRA Engagement Portal on 01 April 2025.
This webinar aims to address processing issues around system failures.
Applicants are encouraged to attend to address issues regarding:

Assistance and guidance to be provided to Industry on managing User Account Profiles to ensure data imports can be linked to correct CIPC entities
Setting up of Divisions under Legal Entity Accounts
Completing missing/incorrect account information
Accessing Legacy Data Applications and completing missing data fields
Sharing learnings/insights on support log themes

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Recording:

Session 3 | SAHPRA Engagement Portal Emergency Webinar to Address Processing Issues
2025-04-11 12:00 - 14:00 | Virtual
The South African Health Products Regulatory Authority (SAHPRA) has become aware of processing issues after the launch of the SAHPRA Engagement Portal on 01 April 2025.
This webinar aims to address processing issues around system failures.
Applicants are encouraged to attend to address issues regarding:

Assistance and guidance to be provided to Industry on managing User Account Profiles to ensure data imports can be linked to correct CIPC entities
Setting up of Divisions under Legal Entity Accounts
Completing missing/incorrect account information
Accessing Legacy Data Applications and completing missing data fields
Sharing learnings/insights on support log themes

Recording:

Engagement Portal | Emergency Webinar to address Section 21 portal issues
2025-04-15 11:00 - 13:00 | Virtual
The South African Health Products Regulatory Authority (SAHPRA) is hosting an Emergency Webinar to address numerous Section 21 technical queries regarding the registration of organisations/ applicants and the submission of applications.
This webinar session aims to focus on the submission of Section 21 applications for Category A Medicines (aka Orthodox or Allopathic medicines).
Applicants are encouraged to attend to address issues regarding:

Timelines involved in phasing in the new portal for Section 21 applications
Process of submitting a Section 21 application for Category A Medicines
How to access the portal’s user manual
Contact details for ICT technical queries and Section 21 -specific queries

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Recording

Radiation Control Webinar | Dental Licencing & Compliance
2025-04-22 10:00 - 12:00 | Virtual
The South African Health Products Regulatory Authority (SAHPRA) hosted an educational and informative webinar to provide support, guidance, and encourage compliance within the dental community throughout South Africa.

Topics Covered

Dental sector compliance with the Hazardous Substance act 15 of 1973
SAHPRA’s services and processes
Being more alert to fake SAHPRA licences
SAHPRA’s licence conditions

Presentations:

M Mpahophe Presentation
M April Presentation
L Nobecu Presentation

Recording:

Webinar on Engagement Portal Updates
2025-05-09 12:00 - 13:00 | Virtual
The South African Health Products Regulatory Authority (SAHPRA) hosted a webinar to provide Industry with updates on the recently launched Engagement Portal.
Why should you attend?
SAHPRA will provide updates on:

SAHPRA Portal roll-out
Discuss the activities for the remainder of May and staggered activation of:

Variations
Response submissions
Renewals for June 2025

Recording:

SAHPRA’s Regulatory Technical Forum (RTF) Virtual Meeting - May 2025
2025-05-15 09:00 - 12:00 | Virtual
The South African Health Products Regulatory Authority (SAHPRA) recently hosted its Regulatory Technical Forum (RTF) Meeting, which brought together key industry stakeholders to discuss regulatory updates.
Areas of discussion on the agenda included:

Medicines (Allopathic)
Clinical Updates
Veterinary Medicines
Complementary Medicines
Inspectorate and Regulatory Compliance
Medical Devices & IVDs
Legislation/Guidelines for Comment/Implementation
IT Upgrade
Section 21 Updates

Presetations:
Clinical Post-Registrations
New Registrations, Renewals & Variations
RTF – Medical Device and Radiation Control
National Action Plan for SF Medicines

Recording:

Webinar | Launch of the NDS Applications Portal
2025-05-15 11:30 - 12:30 | Virtual
The South African Health Products Regulatory Authority (SAHPRA) hosted a webinar to launch the NDS (National Drug Control System) Applications Portal – for import and export applications, specifically for Narcotics and Controlled Substances only.
What was covered?

How does the portal work
How to submit your applications
How to view your application statuses
How to load responses
How the payment process will work

Watch Recording:

Webinar on Engagement Portal - Variations and Renewal Submissions
2025-06-19 09:00 - 10:00 | Virtual
The South African Health Products Regulatory Authority (SAHPRA) hosted a webinar to provide Industry with updates on the Engagement Portal—Variations and Renewal Submissions.
Why should you attend?
SAHPRA provided updates on:

SAHPRA Portal roll-out
Discuss the activities for variations and renewal submissions

Presentations:
Engagement Portal -UPDATE 19 JUNE 2025

Recording:

Webinar on Engagement Portal - General Updates for Improving User Support
2025-07-24 14:30 - 16:00 | Virtual
The South African Health Products Regulatory Authority (SAHPRA) hosted a webinar to provide industry with updates on SAHPRA’s Engagement Portal. The session focused on various areas aimed at improving overall user support.
Attendees learned about:

Clarifications on industry fees
Context and support volumes
Visibility of API Dashboard Tools
HPA – Practical “Support” Use Cases
HPA – General Support Requests
HPA – Continuous Improvements
S21 – Practical “Support” Use Cases
S21 – General Support Requests

Participants had the opportunity to register beforehand to join the event.

Watch Recording:

SAHPRA’s Regulatory Technical Forum (RTF) Virtual Meeting - August 2025
2025-08-28 09:00 - 12:00 | Virtual
Dear Stakeholder,
You are invited to the South African Health Products Regulatory Authority’s (SAHPRA’s) Regulatory Technical Forum (RTF) Meeting.
Areas of discussion on the agenda include:

Medicines (Allopathic)
Inspectorate Updates
Veterinary Medicines
Complementary Medicines
Inspectorate and Regulatory Compliance
Medical Devices & IVDs
Legislation/Guidelines for Comment/Implementation
IT Upgrade
Fees Update

Recording:

Presentations:
RTF – New Registrations and Variations
RTF – BAU New Registrations, Renewals and Variations (all units)
FEASIBILITY STUDY: ROAD MAP

DHA Side Event | Digital Transformation of Medicines Regulation in Africa Engagement
2025-09-02 13:00 - 17:00 | Hybrid [Venue: Innovation Hub]
Inspired by the Digital Health Africa (DHA) Conference 2025, a side event on the Digital Transformation of Medicines Regulation in Africa was hosted collaboratively by the South African Health Products Regulatory Authority (SAHPRA) and Pharmacometrics Africa. The event featured insightful presentations and dynamic discussions aimed at advancing regulatory innovation across the continent.

Areas of discussion on the agenda included:

Strengthening continental collaboration and reliance through digitalisation and AI

Introduction and overview of AMRH/AMA Digital Ecosystem
Introduction to the AMRH/AMA AfriVigilance platform

NRA perspectives of their digitalisation and AI journey

Digitalisation journey of MCAZ
Digitalisation journey of SAHPRA
Global North Regulator experiences

Regulating AI as a medical device
Industry perspectives

Industry perspectives on digitalisation and AI
Tech provider perspectives on AI

Recording:

Medical Devices Webinar | Industry Meeting on Regulatory Updates and Process Improvements
2025-09-05 10:00 - 12:00 | Hybrid [Venue: Innovation Hub]
The South African Health Products Regulatory Authority (SAHPRA) hosted a consultative meeting with industry to communicate updates, compliance to legislative requirements, improve the application process, and enhance overall client service and relations.
Purpose of the webinar:

Update on applicable fees SAHPRA’s services and processes

Annual retention fees and licence cancellation for non-compliant licence holders
Licence fees

Renewal applications – ISO 13485 certification requirements
Guidelines for the management of medical device vigilance
Port health

Date: 05 September 2025
Time: 10:00 to 12:00
Presentation
Medical Devices Unit | Industry Stakeholder Engagement

Recording:

SAHPRA’s Regulatory Technical Forum (RTF) Virtual Meeting - November 2025
2025-11-06 09:00 - 12:00 | Virtual
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

Industry Webinar on Product Registration Feasibility Study and Related Activities
2025-12-09 10:00 - 12:00 | Virtual
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 the Medical Devices Registration Subunit.

Discussion Points

Update on the product registration feasibility study
Communication on veterinary medical devices
Communication on AI and Machine Learning
Communication/position papers and guidelines
Collaborative Registration Process (CRP)

Date: Tuesday, 09 December 2025
Time: 10:00 – 12:00

Presentations
Publications
Product Registration Feasibility Study update
Communication on Regulatory requirements for vet medical devices includig IVD’s

Recording

Webinar on Industry Engagement on Reliance Applications
2025-12-11 09:00 - 12:00 | 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.

Download Presentation
Download Q&A’s

Recording:

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

Download Presenatations

Recording

Webinar on Import Authorisation Requirements for Health Products Importers
2026-06-29 13:00 - 15:00 | Virtual
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 | Virtual
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

Download Presentations

Recording

Updates on the Regulation of Advertising of Health Products Webinar
2026-07-28 15:00 - 16:00 | Virtual
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 | Virtual
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.

Download Webinar Presentation

Recording
