eCTD Go-live in South Africa
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. Find out more
12 events found.
The Process of Vaccine Approval webinar
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...
SAHPRA COVID19 Response Webinar
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...
AEFI reporting microsite media briefing webinar
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...
Self-reporting suspected adverse drug reactions (ADRs) of medicines and vaccines webinar
VirtualIn 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....
Enhancing the public trust in COVID-19 vaccination
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...
Update on COVID-19 Therapies
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...
Vaccine Safety: Side Effects & Adverse Events Following Immunisation (AEFIs) Webinar
VirtualAs 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...
3rd World Conference on Pharmacometrics (WCoP)
Century City Conference Centre Cape Town, Western Cape, South AfricaThe 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...
SAHPRA Industry workshop
VirtualThe 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,...
Webinar: Codeine-Containing Medicines – Unpacking the dangers and abuse
SAHPRA hosted a Live Webinar: Codeine-Containing Medicines – Unpacking the Dangers of Irresponsible Behaviour and Abuse. Recording below: