Patient safety resonates with SAHPRA’s mission of ensuring that the public is protected by registering and regulating all health products so that they comply with SAHPRA’s pillars of safety, quality, efficacy and performance. This involves ensuring that stringent regulatory requirements are followed before any health product is made...
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11 June 2021 Background World Health Organization (WHO) estimates from 2017 indicates that 10.5% of medical products available in low- and middle-income countries (LMICs) are “substandard or falsified” (SF). Substandard health products are approved by the national regulators, but they do not comply with adequate standards due...
15 December 2020 With the advent of COVID-19, vaccine development is a critical area of need. SAHPRA has been proactive and is prepared for the vaccine registration process. The readiness programme includes the establishment of a specialised working group, the COVID-19 Vaccine Registration Working Group (CVr...
The World Health Organisation (WHO) has declared COVID-19 to be a Public Health Emergency of International Concern on 30 January 2020. On 14 March 2020, President Ramaphosa announced several steps to curb transmission and on 23 March 2020 further steps were announced. These steps reflect...