3rd Session | Updates on Regulatory Information Management System (RIMS) Roll-Out
2024-04-19 13:00 - 14:00 (Africa/Johannesburg) | Virtual
The South African Health Products Regulatory Authority (SAHPRA) hosted the 3rdsession of our industry webinar focused on the Regulatory Information Management System (RIMS) roll-out updates.
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SAHPRA’s Regulatory Technical Forum (RTF) Inaugural Meeting
2024-05-16 09:00 - 12:00 | Virtual
South African Health Products Regulatory Authority (SAHPRA) hosted the Inaugural Meeting of the Regulatory Technical Forum (RTF).
Areas of discussion on the agenda included:

Veterinary Medicines
Complementary Medicines
Pharmacovigilance
Medical Devices and IVDs
Allopathic Medicines
Radiation Control
Legislation/Guidelines for Comment or Implementation

Date: 16 May 2024
Time: 09:00 – 12:00
Download Presentations:

RTF Inspectorate update
Harmonisation initiatives in veterinary medicines regulation

Watch Recording Below:

SAHPRA’s Hybrid Stakeholder Engagement Meeting
2024-06-14 08:30 - 10:30 | Hybrid [Venue: Innovation Hub]
The South African Health Products Regulatory Authority (SAHPRA) hosted a Hybrid Stakeholder Engagement Meeting. The meeting was held in person and via our virtual platform.

Areas of discussion on the agenda included:

SAHPRA’s strategy to support local manufacturing of vaccines as per African Union Agenda 2063
Feedback on the B-BBEE Draft Policy

Download Presentations

SAHPRA Responses to comments received on the draft B-BBEE Policy
SAHPRA Draft Policy on Prioritisation of Local Manufacturers

Watch Recording

Industry Workshop on FAQs and Common Deficiencies for APIMF Submission
2024-06-28 09:00 - 10:30 | Hybrid [Venue: Innovation Hub]
The South African Health Products Regulatory Authority (SAHPRA) hosted an industry workshop to empower and educate you on the FAQs & Common Deficiencies for APIMF [Active Pharmaceutical Ingredient Master File] Submission.
The workshop provided information to the Industry Stakeholders and APIMF holders on the SAHPRA’s current APIMF submission procedure. In addition, it highlighted the information on the FAQ/common deficiencies evaluators encounter when assessing the API.

Download Presentations

APIMF Submissions
FAQs & Common Deficiencies for APIMF Submission Documents
GMP Requirements for APIs

Watch Recording

Medical Devices Stakeholder engagement Industry Meeting
2024-06-28 09:00 - 12:30 | Virtual
A Consultative meeting with the industry to communicate updates, and improve the application process, as well as the overall services and relations.
Date: 28 June 2023
Time: 9h00 to 12h30
Watch Recording

CCI Webinar Series | Module 1 | Holistic Management for pain, cough & colds
2024-07-10 19:00 - 20:00 | Hybrid [Venue: Innovation Hub]
The South African Health Products Regulatory Authority (SAHPRA) recently hosted the launch webinar for our Codeine Care Initiative (CCI) series. This inaugural webinar focused on the holistic management of pain, cough, and colds.
What was covered:

Insightful information on pain, cold, and cough management.
An engaging session where attendees had the opportunity to ask burning questions and engage with experts on the topic.

Who attended:

Industry stakeholders
Healthcare professionals

Download Presentations:
Holistic Cough & Cold Management
Holistic Pain Management
Watch Recording:

Industry Webinar on SAHPRA’s eCTD Specification 3.0
2024-07-19 09:00 - 22:00 | Virtual
The South African Health Products Regulatory Authority (SAHPRA) hosted an informative workshop on the upcoming eCTD Specification 3.1 and the launch of the new Application Submission Portal. This was the first of three workshops.
Presentations
Download Presentation
Watch Recording

CCI Webinar Series: Module 2 | Legislative Review
2024-08-07 19:00 - 20:00 | Hybrid [Venue: Innovation Hub]
The South African Health Products Regulatory Authority (SAHPRA) hosted the 2nd webinar in our Codeine Care Initiative (CCI) series. Our first module had focused on the holistic management of pain, cough, and colds.

This 2nd webinar focused on a review of legislation around codeine-containing medicines.

Presentations
1. Requests for Information related to selling of Medicines
2. Overview of Legislative Requirements
3. Overview of Codeine Regulation

Watch Recoding:

Industry Workshop: eCTD’s Introduction of Specification 3.1
2024-08-08 09:00 - 10:00 | Hybrid [Venue: Innovation Hub]
The South African Health Products Regulatory Authority (SAHPRA) hosted the second industry workshop in a series of informative workshops on eCTD. This webinar introduced you to Specification 3.1.
The discussion points were:

Changes from Specification 3.0
Envelopes
Headings
Lifecycle maintenance
Validations
Baselines
Closing sequences

Presentation
Introduction to the ZA eCTD Specifications 3.1

Watch Recording

SAHPRA's Regulatory Technical Forum (RTF) Virtual Meeting
2024-08-22 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:

Comments on the newly established SAHPRA Regulatory Technical Forum
EOI on model dossiers for training
BAU applications and variations
Medicines (Allopathic)
Veterinary Medicines
Complementary Medicines
Inspectorate and Regulatory Compliance
Medical Devices & IDVs
Radiation Control
Legislation/ Guidelines for Comment/Implementation
IT Upgrade

Presentations:

SAHPRA RTF New Registrations and Variations
RTF Inspectorate update
Medical Device Regulatory Roadmap
ICH Survey Results Presentation RTF meeting

Recording:

CCI Webinar Series | 3rd Module | Patient Safety - codeine’s place in pharmaceutical care
2024-08-28 19:00 - 20:00 | Virtual
The South African Health Products Regulatory Authority (SAHPRA) recently hosted the 3rd webinar in our Codeine Care Initiative (CCI) series, focusing on Patient Safety – Codeine’s Place in Pharmaceutical Care.

Following our first module, which centred on holistic management for pain, cough, and colds, and the second, which highlighted the legislation surrounding codeine-containing medicines, this third session delved into the crucial topic of patient safety.
Why Was This Webinar Important?
Participants had the opportunity to gain a deeper understanding of the vital role healthcare professionals play in supporting patients with responsible self-care. The session provided valuable guidance and advice on ensuring patient safety when dealing with codeine-containing medicines.
Who attended?

Industry Stakeholders
Healthcare Professionals

This webinar proved to be an essential platform for those invested in the safe and effective use of codeine in pharmaceutical care.

Presentations

Dr Andrew Scheibe – Codeine Use & Harm Reduction
Dr Johann Kruger – CCI overview

Watch Recording

Industry Workshop: Specification 3.1 Processes
2024-09-13 09:00 - 10:00 | Virtual
The South African Health Products Regulatory Authority (SAHPRA) hosted the third industry workshop in a series of informative sessions around eCTD. This webinar focused on Specification 3.1 processes.
The processes covered included:

Baselines-Iterative
TOA
Splitting the eCTD
Multiple applications (replicas, clones, and duplicates)
Line Extensions
Cancellations
Withdrawals

Presentations
Download Presentation

Watch Recording

SADC Webinar: Substandard and Falsified health products: situational analysis and collaborations
2024-09-18 13:00 - 14:30 | 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:
