SAHPRA

SADC Webinar: Substandard and Falsified health products: situational analysis and collaborations
2024-09-18 13:00 - 14:30 (Africa/Johannesburg) | Virtual
The South African Health Products Regulatory Authority (SAHPRA), together with the SADC SF Group, were excited to extend a special invitation to you for the SADC SF Group Webinar on Substandard and Falsified Health Products: situational analysis and collaborations.
Key Highlights:

Broader awareness and status of the fight against substandard and falsified medical products mainly within the SADC region and a glance of global work.
The dangers of using SF medical products and overall impact within these countries.
Insights into general activities relating to prevention, detection, and response to SF medical products in the region and beyond.

Who attended:

Health professionals
South African public
Stakeholders from NRAs
Civil society
Research institutions
Public health experts
Policy makers

Download Presentations:

SADC Webinar – SF Situational Analysis – AUDA-NEPAD
SADC Webinar – SF Situational Analysis -TMDA
SADC Webinar – SF Situational Analysis -ZAMRA

Watch Recording

Industry Workshop: Launch of the SAHPRA Engagement Portal
2024-09-20 09:00 - 11:00 | Virtual
The South African Health Products Regulatory Authority (SAHPRA) hosted the launch of the SAHPRA Engagement Portal.

The expected outcomes:

Overview
Account administration
Training

Who attended?

Industry stakeholders

Presentation
Download Presentation
Watch Recording

SAHPRA's Regulatory Technical Forum (RTF) Virtual Meeting
2024-11-08 09:00 - 12:00 | Virtual
The South African Health Products Regulatory Authority (SAHPRA) hosted industry stakeholders at the Regulatory Technical Forum (RTF) Meeting.
Areas discussed on the agenda included:

EOI on model dossiers for training
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
HPA Updates
Medical Devices and Radiation Control Updates
Digitalisation Project Updates

Recording

SAHPRA-WHO Webinar | Implementation of National Action Plan for fighting SF Medical Products
2024-11-13 13:00 - 14:30 | 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 | Virtual
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 | Virtual
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 | Virtual
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 | Virtual
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 | Virtual
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 | Virtual
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 | Virtual
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 | Virtual
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

Download presentation

Recording:

Session 2 | SAHPRA Engagement Portal Emergency Webinar to Address Processing Issues
2025-04-09 14:00 - 16:00 | 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

Download Presentation

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

Download Presentation

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:
