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...
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
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 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...
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...
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....
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...
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...
