SAHPRA

SAHPRA-WHO Webinar | Implementation of National Action Plan for fighting SF Medical Products
2024-11-13 13:00 - 14:30 (Africa/Johannesburg) | Virtual
The South African Health Products Regulatory Authority (SAHPRA), in collaboration with the World Health Organization (WHO), recently hosted a webinar to introduce the WHO Pilot on the Implementation of the National Action Plan for combating substandard and falsified (SF) medical products in South Africa.
The event brought together key stakeholders to discuss the project’s overview and the critical roles and collaborations required to implement the National Action Plan. Participants explored strategies for preventing, detecting, and responding to the challenges posed by fake, falsified, unregistered, and substandard medical products. The webinar emphasised the significant impact of stakeholder contributions on the country, the region, and the global fight against such threats.
Attendees gained valuable insights into their roles and responsibilities within the National Action Plan, fostering collaboration in efforts to eradicate SF medical products. The discussions laid the groundwork for developing unified strategies that advance the fight against these harmful practices, benefiting public health locally and internationally.
Presentations
NAP Webinar Prevention, Detection and Response Strategies on SFMPs – WHO-South Africa
NAP Webinar – Prevention, Detection and Response Strategies on SFMPs – Team Lead – WHO SFMP
Implementation of NAP on Fighting Unlawful Medicinal Products in South Africa – An Industry Perspective
Recording:
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2024 MedSafety Webinar: Improving medicine safety through correct use & adverse event reporting
2024-11-13 18:00 - 19:00
As part of its pharmacovigilance programme, the South African Health Products Regulatory Authority (SAHPRA) recently partnered with the Independent Community Pharmacy Association (ICPA) to deliver an informative webinar on reporting adverse drug events and promoting the safe use of medicines to reduce the occurrence of such events.
The webinar provided valuable insights into safe prescribing and dispensing practices, screening for other conditions and potential drug interactions, and the importance of pharmacovigilance. Attendees were also reminded of the proper procedures for reporting adverse events, ensuring better health outcomes.
This event was tailored for pharmacists, nurses, and medical practitioners, highlighting their critical roles in ensuring medication safety and fostering a robust pharmacovigilance culture in South Africa.

Presentations
SAHPRA – Adverse Event Monitoring
ICPA – Safe Prescribing, Dispensing, and the onus to Report

Recording

Complementary Medicines’ Stakeholder Engagement Hybrid Workshop
2024-11-21 08:00 - 12:00
The South African Health Product Regulatory Authority (SAHPRA) Complementary Medicines’ (CMs’) Hybrid Workshop successfully took place, offering attendees the option to participate either in person or via a virtual platform.

Key areas discussed during the workshop included:

SAHPRA responded to the 21 questions regarding Complementary Medicines (CMs).
The South African Pharmacy Council’s presentation on GPP Compliance and Inspections.
Insights from the National Department of Health regarding Pharmacy Premises Licences, as outlined in Section 22 of the Pharmacy Act 53 of 1974.
The National Consumer Commission’s role is to safeguard the public through oversight of non-medicinal “Grey Area Products.”
Industry representatives’ responses to SAHPRA’s feedback on the questions raised.

The workshop provided a valuable platform for dialogue between regulators and stakeholders

Presentations
SAHPRA | Feedback on the list of 21 Complementary Medicines’ Questions
National Department of Health | Pharmacy premises licences in terms of Section 22 of the Pharmacy Act 53 of 1974
South African Pharmacy Council | GPP Compliance and Inspections
National Consumer Council | Role of the NCC in Safeguarding the General Public – Proving Oversight on Products

Recording

Industry Stakeholder Engagement | Medical Devices Unit
2024-11-26 10:00 - 13:00
The Medical Devices Unit of the South African Health Products Regulatory Authority (SAHPRA) hosted a consultative meeting with Industry. The meeting aimed to communicate updates, ensure compliance with legislative requirements, discuss improvements to the application process, and enhance overall client service and relations.

Areas of discussion included:

Payment of applicable fees

Annual retention fees (including cancellation licences for non-compliant licence holders)
Licence fees

Renewal applications
Guidelines for the management of medical device vigilance
ISO 13485 Certification – implementation plan for April 2025

Download presentation

Watch Recording

Radiation Control Webinar | Veterinary Licence Compliance
2025-02-28 10:00 - 12:35
The Radiation Control’s Licencing Unit of the South African Health Products Regulatory Authority (SAHPRA) invites you their Veterinary Licence Compliance Webinar to aid support, guidance and encourage compliance within the veterinary community.

Areas of discussion include:

Improve your understanding of veterinary sector compliance with the Hazardous Substance act 15 of 1973.
Enhance your awareness about SAHPRA’s services and processes.
Increase your knowledge about SAHPRA’s licence conditions.

Presentations:
Inspection and Enforcement Process
Compliance Requirements for Medical Devices
Compliance Requirements and Conditions (Regulations)
Compliance Requirements and Conditions

Recording:

SAHPRA’s Regulatory Technical Forum (RTF) Virtual Meeting March 2025
2025-03-13 09:00 - 12:00
The South African Health Products Regulatory Authority (SAHPRA) recently hosted its Regulatory Technical Forum (RTF) Meeting, bringing together key industry stakeholders to discuss regulatory updates.
Areas of discussion on the agenda included:

BAU Applications and Variations
Medicines (Allopathic)
Veterinary Medicines
Complementary Medicines
Inspectorate and Regulatory Compliance
Medical Devices & IVDs
Radiation Control
Legislation/Guidelines for Comment/Implementation
IT Upgrade

Presentations
Medical Devices and Radiation Control Presentation
New Registrations, Renewals & Variations

Recording

Launch of Engagement Portal Webinar
2025-03-19 13:00 - 15:00
The South African Health Products Regulatory Authority (SAHPRA) is launching an online applications platform. This platform hosted several application processes, which are enabled across different phases in the overall implementation of their engagement platform.
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

Presentations
SAHPRA Engagement Portal presentation

Recording

Industry Awareness Webinar | Introduction to the New S21 Portal
2025-03-28 10:00 - 11:00
The South African Health Products Regulatory Authority (SAHPRA) hosted an educational and informative webinar to provide broader awareness of the SAHPRA Engagement Portal. This webinar session focused on the submission of Section 21 applications for Category A Medicines (also known as Orthodox or allopathic medicines).
You have an opportunity to learn about:

Navigate the SAHPRA Engagement Portal efficiently
Manage user profiles, including login, logout, and password resets
Understand the process of submitting and tracking applications

Presentations
Introduction to the New Section 21 Portal
SAHPRA Engagement Portal S21 Webinar

Recording

Session 1 | SAHPRA Engagement Portal Emergency Webinar to Address Processing Issues
2025-04-07 14:00 - 16:00
The South African Health Products Regulatory Authority (SAHPRA) became aware of processing issues after the launch of the SAHPRA Engagement Portal on 01 April 2025.
This webinar aimed 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 2 | SAHPRA Engagement Portal Emergency Webinar to Address Processing Issues
2025-04-09 14:00 - 16:00
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

Download Presentation

Recording:

Session 3 | SAHPRA Engagement Portal Emergency Webinar to Address Processing Issues
2025-04-11 12:00 - 14:00
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
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

Download Presentation

Recording

Radiation Control Webinar | Dental Licencing & Compliance
2025-04-22 10:00 - 12:00
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
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
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
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
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
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
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

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