Webinar: Updates on Adverse events following Immunization
2022-08-04 09:00 - 10:30 (Africa/Johannesburg) | Virtual
South African Health Products Regulatory Authority (SAHPRA) held a live media briefing where we provide an update on Adverse Events Following Immunisation. Representatives of SAHPRA and the Minister of Health, Dr Joe Phaahla were in attendance.
When did it happen?
04 August 2022

Watch the webinar recording below:

Webinar - Good Regulatory Practices and its implementation in the Medical Devices Sector
2022-08-11 14:00 - 16:00 | Virtual
We are pleased to invite you to participate in an online webinar on “Good Regulatory Practices and its implementation in the Medical Devices Sector” that will take place on 10 and 11 August 2022 under the joint work of the COVID-19 Medical Device Regulatory Convergence Project (MDRC) and the South African Health Products Regulatory Authority (SAHPRA). The program for the event is attached which includes recognized subject matter experts from the World Health Organization and World Trade Organization, amongst others.
This is the first in a series of workshops being organized under the MDRC coordinated efforts with SAHPRA on capacity building with relevant stakeholders regarding the development of capacities on Good Regulatory Practices and Good Reliance Practices for Medical Technology Regulation through the utilization of international references and standards.
To participate, please register via the following link through which you will receive a personalized link to connect to the two sessions
https://us06web.zoom.us/webinar/register/WN__zCfGnPqQO6JRKwrhZpGjQ
We look forward to your engagement,
Sincerely,
Sandra Ligia González Dimakatso Mathibe
Tier 2 (MedTech) Lead – MDRC Snr Manager, Medical Device Unit – SAHPRA
slgonzalez@standardsalliance-mdrc.org dimakatso.mathibe@sahpra.org.za

Workshop - Pharmacovigilance Systems
2022-08-30 09:00 - 12:00 | Virtual
The SAHPRA Vigilance and Inspectorate units hosted a workshop on the Pharmacovigilance Systems’ Guideline for Holders of Certificate (HCR).
The workshop is scheduled for:

Date: 30 August 2022
Time: 09h00 – 12h00
Registration link: https://bit.ly/pv-systems-workshop

Event recording:
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A Conversation on Medicine Safety - Increasing Awareness and Reporting of Adverse Events
2022-09-26 10:00 - 11:30 | Virtual
In commemoration of World Patient Safety Day and World Pharmacist Day (observed annually on 17 and 25 September, respectively), the South African Health Products Regulatory Authority (SAHPRA) hosted a Medicine Safety Webinar on 26 September 2022.

The webinar focused on increasing awareness and reporting of adverse events including medication errors, as we create a healthier world.

We have invited panellists from various sectors to share their knowledge, experience, and expertise to begin this important conversation focusing on the:

Global Perspective on World Patient Safety Day | World Pharmacist Day
Role of the South African Pharmacy Council (SAPC) in the promotion of medicine safety
Role of SAHPRA in the promotion of medicine safety | Med Safety App

Hear from various speakers within the South African Pharmacy Council, the University of KwaZulu-Natal and industry.

Webinar recording:

Conformity assessment bodies meeting with SANAS
2022-10-05 09:30 - 12:30 | Virtual
SAHPRA invited all local and foreign Conformity assessment bodies to a joint meeting with SANAS.
The session is scheduled as follows:
Download Agenda
Recording below:

SAHPRA unpacks global accolade upon receiving WHO Maturity Level 3 (ML3)
2022-10-26 12:00 - 13:00 | Virtual
The South African Health Products Regulatory Authority (SAHPRA) hosted a conversation on our recent accolade of attaining the World Health Organisation (WHO) Maturity Level 3 (ML3) for vaccine production.
We had invited some of our Executives, CEO Dr. Boitumelo Semete-Makokotlela, CRO Portia Nkambule, and COO Christelna Reynecke to unpack this global accolade by sharing insights and the impact of receiving this WHO rating.
Our conversation focused on:

Understanding of the opportunities that come with an ML3 ranking for South Africa
Improved understanding of the influence of ML3 on the African vaccine production industry
The impact of ML3 on the South African economy and its citizens

Watch webinar recording below:

The Interpretation of Calibration Certificates for Radiation Monitoring instruments
2022-11-10 09:00 - 10:30 | Virtual
The Radiation Control Unit of the South African Health Products Regulatory Authority (SAHPRA) held a short and free webinar that intends to educate you on how to interpret the calibration certificates for radiation monitoring instruments.
We have invited panellists from two sectors to share their knowledge, experience, and expertise to begin this conversation by focusing on the:

Primary objectives of calibration,
How to use calibrated instruments correctly,
How to interpret calibration certificates, and
How to apply the information provided on the certificate.

Hear from various speakers within the South African Nuclear Energy Corporation and the National Metrology Institute of South Africa.
Watch Recording here:

Webinar | SAHPRA – What We Do And How We Work
2022-11-22 12:00 - 13:30 | Virtual
The South African Medical Association, in collaboration with the South African Health Products Regulatory Authority (SAHPRA), invites you to a webinar that will provide a detailed introduction to the regulator and how it ensures the safety, efficacy and quality of medicines, medical devices and IVDs in South Africa.
The legislative mandates of SAHPRA, as per the National Health Act, 2003 (Act No. 61 of 2003); the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), as amended; and other relevant legislation, regulations and policies will also be explained.
Webinar recording

Webinar on Increasing Awareness and Reporting of Medication Errors
2023-02-23 10:00 - 11:30 | Virtual
The South African Health Products Regulatory Authority (SAHPRA) hosted a conversation on what medication errors are and why it is vital that patients or healthcare professionals report them.
We have invited panellists from two hospitals to share their knowledge, experience, and expertise to begin this important conversation focusing on:

What are medication errors and their impact on patients
Importance of reporting medication errors
Role of SAHPRA in preventing medication errors

Date: 23 February 2023
Time: 10:00 – 11:30
Download presentations
Recording

Webinar on Radiation Control Engagement with Inspection Bodies
2023-02-24 10:00 - 12:00 | Virtual
The Radiation Control Unit of the South African Health Products Regulatory Authority (SAHPRA) hosted an engagement with Inspection Bodies.

We have invited several Inspection Bodies to share their knowledge, experience, and expertise to begin this conversation focusing on the:

Accreditation process by the South African National Accreditation System (SANAS)
Approval process by SAHPRA
Conditions and scope of the Approved Inspection Authorities (AIA)
Improving the workflow of electronic submissions
Improving the quality of QC reports

Recording below:

Webinar on Unpacking Malaria on World Malaria Day
2023-04-25 10:00 - 11:30 | Virtual
The South African Health Products Regulatory Authority (SAHPRA) hosted a webinar to increase awareness and understanding of malaria this World Malaria Day.
The purpose was for the public to learn and engage with experts on malaria.
We had invited panellists from various sectors to share their knowledge to continue this important conversation focusing on the:

Basics of malaria
Approved health products to combat malaria
Malaria prevention and control
Drug resistance surveillance

Watch recording below

Date: 25 April 2023
Time: 10:00
Register NOW: bit.ly/3KTF8Ho

Upcoming Workshop: QOS/QIS and Variation Validation Template
2023-05-22 09:00 - 11:00 | Virtual
The South African Health Products Regulatory Authority (SAHPRA) hosted a workshop to share useful information on populating the QOS and QIS as a replacement for the SCoRe document, as well as information on the Variations Validation template.
Date: 22 May 2023
Time: 09:00 – 11:00
Watch Recording

Webinar on Demystifying Hepatitis
2023-07-26 10:00 - 11:30 | Virtual
The South African Health Products Regulatory Authority (SAHPRA) hosted an exciting conversation on Demystifying Hepatitis to bring more awareness to World Hepatitis Day, celebrated annually on 28 July.
We have invited panellists from various sectors to share their knowledge, experience, and expertise to begin this important conversation focusing on the:

Understanding the basics of hepatitis
How to identify symptoms
Prevention of hepatitis

Date: 26 July 2023
Time: 10:00
Presentations:
Understanding Hepatitis B and C and the 2030 elimination targets
Hepatitis B infection status among South Africans attending public health facilities over a five-year period: 2015 to 2019
Recording below:

Radiation Control’s Regulatory Compliance Webinar
2023-10-25 10:00 - 11:30 | Virtual
The Radiation Control (RadCon) Unit of the South African Health Products Regulatory Authority (SAHPRA) hosted an informational webinar to increase awareness and understanding of radiation control regulatory processes.
You have an opportunity to learn and engage with SAHPRA colleagues on key regulatory compliance processes within the RadCon unit.
What you will learn about:

Regulatory processes
Understanding the licensing process
Role of sub-units within RadCon
Diagnostic and inspection process

Presentations:
SAHPRA Compliance Requirement
RADIATION CONTROL REGULATORY COMPLIANCE
Webinar Recording:

Webinar | Importance of Reporting Adverse Events to SAHPRA | #MedSafetyWeek
2023-11-06 18:00 - 19:30 | Virtual
The South African Health Products Regulatory Authority (SAHPRA) is commemorating the #MedSafetyWeek2023 campaign, in collaboration with South African Pharmacy Council (SAPC), by hosting a webinar focused on the Importance of Reporting Adverse Events.
The #MedSafetyWeek is an international social media campaign organised every year by the Uppsala Monitoring Centre (UMC) to raise awareness of adverse events and national reporting systems.
You have an opportunity to learn and engage with SAHPRA and SAPC colleagues on key safety and reporting issues.
What you will learn about:

Reporting side effects
Side effects experienced at health facilities
Role of pharmacies and patient safety

Date: 06 November 2023
Time: 18:00

Presentations:
JHB Health District
Expanded Program On Immunisation In South Africa

Webinar recording:

Good Regulatory Practices and Technical Competencies
2023-11-14 09:00 - 2023-11-16 18:00 | Hybrid [Venue: Innovation Hub]
This workshop will provide an exchange of information and capacity building between the South African Health Products Regulatory Authority, SAPHRA and partner reference NRAs including the WHO, USFDA, TGA, HSA, ANVISA, covering the core international references for medical device regulatory. The workshop objective is to support and advance to strengthen the soft infrastructure of medical device regulatory framework to incorporate global lessons learned from the COVID-19 pandemic, to better prepare for future health emergencies, to prevent the implementation of unnecessary regulatory barriers to medical technologies, to improve general MD NRA public administration and general public health.

Date: 14 November 2023
Time: 9:00 – 17:30 Pretoria, South Africa (2:00 am – 10:30 ET)
Platform: Hybrid (In-person: Southern Sun Pretoria Hotel, Cnr. Steve Biko and, Pretorius St, Arcadia, Pretoria, 0083). Please register here for virtual or in-person participation.

Register for hybrid event here.

Webinar on Virtual Fee Regulation Workshop with Industry | Revised Fee Regulations
2024-02-22 10:00 - 14:00 | 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)

Download Presentation

Watch Recording

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

Watch Recording:

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.

Download Presentation

Watch Recording:

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.
Download Presentation

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
Download Presentation
Watch recording:

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.
Download Presentation
Watch Recording

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

Download Presentation
Download Feasibility Study
Watch Recording:

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.
Watch Recording:

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:
