The South African Health Products Regulatory Authority (SAHPRA) is the organisation in charge of regulating the use of all Health Products throughout the country. It is part of the
National Department of Health.
SAHPRA assumed the roles of both the Medicines Control Council (MCC) as well as the Directorate of Radiation Control (DRC) which were housed at the National Department of Health (NDoH). SAHPRA was constituted as an independent entity that reports to the National Minister of Health through its board.
History
As of the Substance Act of 1965, The Medicines Control Council (MCC) and Directorate of Radiation Control (DRC) was formed. As of 2018, the South African Health Products Regulatory Authority (SAHPRA) was created to replace the MCC and DRC
Covid-19
Vaccines
Oxford–AstraZeneca (AZD1222)
On 6 February 2021, SAHPRA approved the
Oxford–AstraZeneca COVID-19 vaccine.
After a clinical trial proved to not be effective for mild to moderate illness caused by the
501.V2 variant
The Beta variant, (B.1.351), was a Variant (biology), variant of SARS-CoV-2, the virus that causes COVID-19. One of several Variants of SARS-CoV-2, SARS-CoV-2 variants initially believed to be of particular importance, it was first detected i ...
. The vaccination program was announced to be put on a hold.
Johnson & Johnson (Ad26.COV2.S)
On 17 February 2021, the national
COVID vaccination program was officially rolled out through Phase 3 Trails. On 31 March 2021, SAHPRA approved the
Janssen vaccine for full section 21 mass use.
Pfizer–BioNTech (BNT162b2)
On 16 March 2021, The South African Health Products Regulatory Authority (SAHPRA) approved the
Pfizer-BioNTech vaccine for section 21 Emergency Use Authorisation
Ivermectin
In January 2021, SAHPRA authorised under Section 21 of the
Medicines and Related Substances Act, a
Compassionate Use
Expanded access or compassionate use is the use of an unapproved drug or medical device under special forms of investigational new drug applications (IND) or IDE application for devices, outside of a clinical trial, by people with serious or life ...
Access programme, which gave permission to five importers of unregistered Ivermectin in oral solid dosage form and for health facilities to hold bulk stock. The reasoning for this was to thwart the use of illicit and veterinary-use Ivermectin products. The temporary use of unregistered Ivermectin would still be regulated and prescribed.
On 30 May 2022, SAHPRA terminated the Ivermectin Controlled Compassionate Use Access Programme. This would cease the importation and bulk stocking of unregistered Ivermectin. This reasoning for this was after studying the efficacy of Ivermectin in treating Covid-19, there was no credible evidence that it is effective against it.
See also
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COVID-19 vaccine
A COVID19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2), the virus that causes coronavirus disease 2019 ( COVID19).
Prior to the COVID19 pandemic, an e ...
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COVID-19 pandemic
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COVID-19 pandemic in South Africa
The COVID-19 pandemic in South Africa is part of the ongoing pandemic of coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
On 5 March 2020, Minister of Health Zweli Mkhize had conf ...
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COVID-19 vaccination in South Africa
COVID-19 vaccination in South Africa is an ongoing immunisation campaign against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19), in response to the ongoing pandemic in the ...
Notes
External links
SAHPRA Website
References
2020 in South Africa
2021 in South Africa
Government agencies of South Africa
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