SAHPRA

Webinar: Launch of SAHPRA’s Online OTC Medicines’ directory
2022-06-30 09:00 - 10:30 (Africa/Johannesburg) | Virtual
South African Health Products Regulatory Authority (SAHPRA) hosted a live webinar launching our new and first-of-its-kind Online Directory for over-the-counter (OTC) medicines in South Africa.
When did it happen?
30 June 2022

Watch webinar recording below:

Webinar: Codeine-Containing Medicines - Unpacking the dangers and abuse
2022-06-21 10:30 - 12:00
SAHPRA hosted a Live Webinar: Codeine-Containing Medicines – Unpacking the Dangers of Irresponsible Behaviour and Abuse.
Recording below:

SAHPRA Industry workshop
2022-04-14 09:00 - 12:30 | Virtual
The purposes of the webinar are to provide clarification on the responsibilities of SANAS and SAHPRA with regards to Conformity Assessment Bodies (CABs) operating in South Africa and to have a discussion on the renewal process and expectations from the industry and SAHPRA.
Date: Thursday, 14 April 2022
Time: 09h00 – 12h30

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3rd World Conference on Pharmacometrics (WCoP)
2022-03-29 08:00 - 2022-04-01 17:00 | Century City Conference Centre, Cape Town, Western Cape, South Africa
The South African Health Products Regulatory Authority (SAHPRA) in collaboration with the Bill & Melinda Gates Foundation, CP+ Associates GmbH and Fundisa African Academy of Medicines Development, and after consultations with other African Regulators, convened a regulators expert meeting at the upcoming World Conference on Pharmacometrics (WCOP) that was held in Cape Town, South Africa in 2022.
SAHPRA organisers hosted side meetings during the conference where two (2) sessions were convened. The first reported on progress on capacity strengthening for African regulators, and the second had a specific focus on capacity development for using model-based analyses and pharmacometrics to support regulatory decision making.
The meeting was aimed at achieving the following objectives:
Primary Objective: Seek alignment and consensus from regulatory leadership on the continent on regulatory science capacity development.
Secondary Objectives:

Explore options to build capacity in regulatory agencies in Africa
Determine tools that would be put in place to assess/grade the level of capacity developed
Explore approaches to increase regulators capabilities to review clinical data in dossiers
Develop a Roadmap for capacity development
Collate input from other regulators regarding training programmes that should be implemented going forward

Date/Time:

29 March 2022 – 15:00 – 17:00 SAT
30 March 2022 – 17:00 – 18:00 SAT

Event programme Note of Gratitude Download Presentations

Gallery:

Vaccine Safety: Side Effects & Adverse Events Following Immunisation (AEFIs) Webinar
2022-03-15 10:00 - 11:30 | Virtual
As part of its ongoing response to COVID-19 communications and following a series of successful public events, the South African Health Products Regulatory Authority (SAHPRA) will be hosting a Webinar on “Vaccine Safety and Adverse Events”. The propose of the Webinar is to provide a platform for dialogue and information sharing on AEFIs.
Date: Tuesday, 15 March 2022
Time: 10h00 – 11h30
Speakers
1. Prof Hannelie Meyer, NISEC committee chairperson
2. Prof Marc Blockman, Chair of SAHPRA’s Pharmacovigilance advisory committee
3. Ms Mafora Matlala, SAHPRA Pharmacovigilance Manager
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Update on COVID-19 Therapies
2022-02-21 11:30 - 12:30
SAHPRA was joined by experts to discuss the latest updates on Covid-19 therapies.
Date: Monday, 21 February 2022
Time: 11h30 – 12h30
Speakers
1. Dr. Boitumelo Semete-Makokotlela, SAHPRA CEO
2. Prof. Hannelie Meyer, NISEC committee chairperson
3. Prof Andy Parish, HOD of Internal Medicine (Walter Sisulu University)
4. Dr Jeremy Nel, Infectious Diseases Specialist (Wits University)
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Mitigating COVID-19 Vaccine Hesitancy in South Africa
2021-11-10 10:00 - 11:30

Enhancing the public trust in COVID-19 vaccination
2021-11-09 12:30 - 13:30
Enhancing the public trust in COVID-19 vaccination: Progress and challenges in the regulation, administration and rollout of vaccines in South Africa.
The race for countries to reach herd immunity continues globally. The prolonged Covid-19 pandemic has adversely affected the social and economic standing of many nations and South Africa is no exception. While vaccines bring a glimpse of hope the reality remains, that the successful administration and rollout of Covid-19 vaccines is largely dependent on the enhanced public trust of the vaccines and related institutions. It is also appreciated that the rise of vaccine-related conspiracy theories and myths counter noble global efforts in fighting the Covid-19 Pandemic.
Scifest Africa hosted a webinar that explored the progress and challenges related to the regulation, administration and rollout of Covid-19 Vaccines in South Africa.
The discussion tackled the role of enhanced public trust in attaining vaccination goals as set by the government. The webinar will also investigate the projected impact of Covid-19 vaccine passports in accelerating vaccination for the South African population.

Watch the video below:

Self-reporting suspected adverse drug reactions (ADRs) of medicines and vaccines webinar
2021-09-13 11:00 - 12:30 | Virtual
In February 2021, South Africa’s National Department of Health (NDoH) embarked on a nationwide COVID-19 vaccine rollout plan. The phased approach to immunisation ramped up in July 2021, with a record number of individuals (over a million in a single day) registering for their doses.

AEFI reporting microsite media briefing webinar
2021-08-20 14:00 - 16:00
The South African Health Products Regulatory Authority (SAHPRA), invites you to the launch of the Adverse Events Following Immunisation (AEFI) reporting microsite.
The microsite will keep the public updated on reports of adverse events following immunisation (AEFIs) associated with COVID-19 vaccine administration. All medicines, including vaccines, can cause side effects. In the case of vaccines, side effects or adverse events that occur after vaccine administration are known as AEFIs. However, the benefits of COVID-19 vaccination outweigh the risks. COVID-19 vaccines have proven to prevent severe forms of disease, hospitalisation and death.
Watch the webinar below:
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SAHPRA COVID19 Response Webinar
2021-07-01 10:00 - 11:00
SAHPRA and PATH hosted a webinar panel discussion on the coordinated introduction of COVD19 vaccines and tools and the important role of the South African Health Products Regulatory Authority (SAHPRA) and the National Department of Health in COVID19 vaccine planning and roll-out whilst ensuring equitable access and safety for all South Africans.
Watch the webinar below:
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The Process of Vaccine Approval webinar
2021-06-24 10:00 - 11:00
The normal process for the evaluation of a vaccine necessitates that all the required information regarding product safety, efficacy and quality be provided at the time of submission. In other words, all the clinical trial data for safety and efficacy from phase one to three should be provided together with manufacturing information of the product quality.
In an effort to respond to the pandemic, SAHPRA introduced another mechanism to facilitate the review of COVID-19 applications, which is the rolling review process. The rolling review is a mechanism that facilitates the submission of data as it becomes available. This webinar will focus on the vaccine approval processes.
Watch the webinar below:
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eCTD Go-live in South Africa
2016-11-19 09:00 - 16:00
The Medicines Control Council (MCC) went live with eCTD for New Chemical Entities on 01 April 2016, and the intended go-live date for generic applications is 02 January 2017.
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Immunogenicity of Biopharmaceuticals workshop
2016-07-05 09:00 - 2016-07-10 17:00 | Osaka, Japan, Japan
The International Council for Harmonisation (ICH) met in Osaka, Japan on 5-10 November 2016. As part of the objective to extend its global outreach, ICH is pleased to welcome the Agência Nacional de Vigilância Sanitária (ANVISA) from Brazil and the Ministry of Food and Drug Safety (MFDS) from South Korea as the first new regulatory Members, together with the Biotechnology Innovation Organization (BIO) as a new industry association Member.
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