SAHPRA

South African Health Products Regulatory Authority

South African Health Products Regulatory Authority

Regulating health entity of the South African Department of Health

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.[1]

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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.[3]

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[4][5]

Covid-19

Vaccines

Main article: COVID-19 vaccination in South Africa

Oxford–AstraZeneca (AZD1222)

On 6 February 2021, SAHPRA approved the Oxford–AstraZeneca COVID-19 vaccine.[6]

After a clinical trial proved to not be effective for mild to moderate illness caused by the 501.V2 variant. The vaccination program was announced to be put on a hold.[7]

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.[8]

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 [9]

Ivermectin

In January 2021, SAHPRA authorised under Section 21 of the Medicines and Related Substances Act, a Compassionate Use 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.[10]

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.[11]

See also

Notes

    References

    1. [1]
      "Who we are". SAHPRA. Archived from the original on 30 June 2023. Retrieved 30 June 2023.
    2. [2]
      "SAHPRA 2020 Report" (PDF). sahpra. Retrieved 20 March 2021.
    3. [3]
      "Who we are". SAHPRA. Retrieved 20 March 2021.
    4. [4]
      Keyter, Andrea; Banoo, Shabir; Salek, Sam; Walker, Stuart (4 December 2018). "The South African Regulatory System: Past, Present, and Future". Frontiers in Pharmacology. 9: 1407. doi:10.3389/fphar.2018.01407. ISSN 1663-9812. PMC 6300068. PMID 30618735.
    5. [5]
      "12 questions answered on the state of SAHPRA • Spotlight". Spotlight. 5 December 2018. Retrieved 20 March 2021.
    6. [6]
      "New vaccine trial starts in SA that targets 501Y.V2 – and it may include a booster pill". BusinessInsider. Retrieved 20 March 2021.
    7. [7]
      Mueller, Benjamin; Robbins, Rebecca; Chutel, Lynsey (7 February 2021). "AstraZeneca's Vaccine Does Not Work Well Against Virus Variant in South Africa". The New York Times. ISSN 0362-4331. Retrieved 8 February 2021.
    8. [8]
      "'Can I close my eyes?' Ramaphosa has Covid-19 jab with Khayelitsha hospital staff". TimesLIVE. Retrieved 17 February 2021.
    9. [9]
      Staff Writer. "South Africa approves Pfizer Covid-19 vaccine for emergency use". Retrieved 19 March 2021.
    10. [10]
      "Section 21 Access to Unregistered Medicines: IVERMECTIN CONTROLLED COMPASSIONATE USE PROGRAMME" (PDF). 28 January 2021.
    11. [11]
      "SAHPRA statement on the termination of the "Ivermectin Controlled Compassionate Use Access Programme"" (PDF).


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