SAHPRA

Enhancing the public trust in COVID-19 vaccination
2021-11-09 12:30 - 13:30 (Africa/Johannesburg)
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.

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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.
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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.
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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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