SAHPRA

SAHPRA COVID19 Response Webinar
2021-07-01 10:00 - 11:00 (Africa/Johannesburg)
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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