Webinar on Virtual Fee Regulation Workshop with Industry | Revised Fee Regulations
2024-02-22 10:00 - 14:00 (Africa/Johannesburg) | Virtual
South African Health Products Regulatory Authority (SAHPRA) hosted a virtual workshop in the Virtual Fee Regulation Workshop with Industry. The workshop addressed the responses to public comments and proposed changes to the Revised Fee Regulations.

Thu, Feb 22, 10:00 AM – 2:00 PM (CAT)

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Webinar on Awareness of Substandard & Falsified Medications in South Africa – Understanding Impact
2024-02-28 15:00 - 16:30 | Virtual
The South African Health Products Regulatory Authority (SAHPRA) hosted a webinar on the Awareness of Substandard & Falsified Medications in South Africa – Understanding Impact.
Key Highlights:

Understanding the basics of substandard and falsified medicines
Identifying the dangers of consuming untested and unauthorised medicines
Importance of reporting agencies/outlets to curb the circulation of these medicines

Expect to hear from continental experts from the Food and Drug Authority Ghana (FDA Ghana), the National Agency for Food and Drugs Administration and Control (NAFDAC), Medicines Control Authority of Zimbabwe (MCAZ) to name a few.
Our webinar will be facilitated by seasoned journalist, Zikhona Tshona.
Event Details:

Topic: Awareness of Substandard & Falsified Medications in South Africa – Understanding Impact
Date: Wednesday, 28 February 2024
Time: 15:00 – 16:30 (SAST)

Presentations:
CIPC – Counterfeit Medicines – Awareness of Substandard and Falsified Medications in South Africa
SAPS – Counterfeiting operations
BoMRA – Post Market Surveillance
FDA Ghana – Enforcement Directorate
MCAZ – How Zimbabwe is affected by SFs and approach to Prevention, Detection and Response
NAFDAC – Perspectives from NAFDAC

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Virtual Training Session | How to use the OTC Online Medicines Directory Toolkit
2024-03-07 10:00 - 11:30 | Virtual
The South African Health Products Regulatory Authority (SAHPRA), in conjunction with the Selfcare Association of South Africa, hosted a virtual training session on How to use the OTC Online Medicines Directory Toolkit.
By registering, you have an opportunity to:

grasp and understand how you can apply key visuals to your Over-The-Counter products.
learn how to activate the OTC Online Medicines Directory across your websites, social media or point-of-sale materials.

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Industry Webinar | Updates on Regulatory Information Management (RIMS) Roll-Out
2024-03-14 11:00 - 13:00 | Virtual
The South African Health Products Regulatory Authority (SAHPRA) is hosting an Industry webinar for updates on the Regulatory Information Management System (RIMS) roll-out.
What to expect?

SAHPRA will start with cut-over activities during the course of March 2024 and the implementation process on 02 April 2024. We have modernised the eCTD Guideline and have introduced a new flexible management structure to allow SAHPRA to add new submission types more easily in future and also manage the validation of submissions a lot easier.
As part of the RIMS implementation, all eCTD applications (New applications, Renewal Applications and Variation applications – Type Ia, Ib and II) will be managed in the docuBridge environment and will be subject to the eCTD guidelines and requirements accordingly. From April to 30 June 2024, there is an interim requirement for a simple XML file to be included along with the eCTD dossier once loaded onto sFTP. We will go through the XML file requirements and duly share a “How-To” document and the simple template on the new Electronic Submissions Landing page.
SAHPRA will also take the attendees through the roadmap for activities planned with the specific milestones for April 2024, July 2024 and October 2024.
We will have a high-level discussion around the custom-developed Portal and also discuss the process we will be running to invite a limited number of Industry users to participate in the Focus Group testing, along with internal users in May 2024, June 2024 and September 2024 for the Portal Phase I test and feedback discussions.

Who should attend?
It is quite important for the Industry users who will be preparing the submissions for Orthodox medicines and Biological medicines to attend this session to be apprised of the specifications guideline updates and linked changes and also where to find the relevant documents of matrix links.
A similar Update session will be held once the eSubmission specifications and guidelines are ready – which tentatively will be held in July 2024.
We want this webinar to be interactive and engaging – so be sure to ask questions during the session through the chat interface.
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Please note that we are unable to provide the video recording due the global outage of MS Office 365 that affected the recording of the Teams Meeting. However, please have a look at the presentation from our COO, Christelna Reynecke on the South African eCTD 3.0 Launch – 14 March 2024.
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Virtual Meeting | Conformity Assessment Bodies Meeting
2024-03-25 10:00 - 13:00 | Virtual
The South African Health Products Regulatory Authority (SAHPRA), in collaboration with the South African National Accreditation System (SANAS), hosted a Conformity Assessment Bodies (CABs) Virtual Meeting.
What was discussed?

Extension of scope of practice to include technical dossier review
SANAS Accreditation process
SAHPRA requirements and future process

Who attended?

Local and International CABs

Meeting Details

Date: 25 March 2024
Time: 10:00 – 13:00

Virtual Meeting Presentations:
SAHPRA approval process for CABs
Proposed Product Registration Feasibility Studies Model And Proposal For Cabs Support
SANAS Accreditation Process
Criteria For Certification Body Accreditation in the Scope of Product, Process and Service Certification
Virtual Meeting Recording:

Industry Workshop | Understanding SAHPRA’s Risk Management Plan Guidelines
2024-04-11 09:00 - 12:00 | Virtual
The South African Health Products Regulatory Authority (SAHPRA) hosted an industry workshop to empower and educate you on the Authority’s requirements when submitting Risk Management Plans (RMPs).
This workshop highlighted the importance of maintaining RMPs to ensure the safety of medicines, while also sharing requirements for compliance.
Date: 11 April 2024
Time: 09:00 to 12:00
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2nd Session | Updates on Regulatory Information Management System (RIMS) Roll-Out
2024-04-12 09:00 - 10:30 | Virtual
The South African Health Products Regulatory Authority (SAHPRA) hosted the 2nd session of our industry webinar focused on the Regulatory Information Management System (RIMS) roll-out updates.
The session was recorded and published on the SAHPRA website.
A similar Update session will be held once the eSubmission specifications and guidelines are ready – which tentatively will be held in July 2024.
We want this webinar to be interactive and engaging – so be sure to ask questions during the session through the chat interface.
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SAHPRA’s Medical Devices’ Registration Update – Upcoming Feasibility Study
2024-04-19 10:00 - 13:00 | Virtual
The Medical Devices Unit of the South African Health Products Regulatory Authority (SAHPRA) hosted an awareness session on this unit’s medical device registration update on the upcoming voluntary feasibility study.
Date: 19 April 2024
Time: 10:00 to 13:00

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Download Feasibility Study
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3rd Session | Updates on Regulatory Information Management System (RIMS) Roll-Out
2024-04-19 13:00 - 14:00 | 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
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RTF Inspectorate update
Harmonisation initiatives in veterinary medicines regulation

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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

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

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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.

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

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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
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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
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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
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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

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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

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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

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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
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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

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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
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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

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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
