South African Health Products Regulatory Authority

The South African Health Products Regulatory Authority (SAHPRA) is the organization in charge of regulating the use of all Health Products throughout the country.

South African Health Products Regulatory Authority
TypeGovernment company
IndustryMedical Regulation
HeadquartersGauteng, South Africa
Area served
South Africa
RevenueIncrease R261.6 million [1]
Increase R308.3 million [1]
Total assetsIncrease R45.06 million [1]
Websitewww.sahpra.org.za

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.[2]

HistoryEdit

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[3][4]

Covid-19 VaccinesEdit

Oxford–AstraZeneca (AZD1222)Edit

On 6 February 2021, SAHPRA approved the Oxford–AstraZeneca COVID-19 vaccine vaccine.[5]

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.[6]

Johnson & Johnson (Ad26.COV2.S)Edit

On 17 February 2021, the national COVID vaccination program was officially rolled out through Phase 3 Trails. On 31 March 2021, SAHPRA approved the Johnson & Johnson vaccine for full section 21 mass use.[7]

Pfizer–BioNTech (BNT162b2)Edit

On 16 March 2021, The South African Health Products Regulatory Authority (SAHPRA) approved the Pfizer-BioNTech vaccine for section 21 Emergency Use Authorisation [8]

See alsoEdit

NotesEdit

External linksEdit

ReferencesEdit

  1. ^ a b c "SAHPRA 2020 Report" (PDF). sahpra. Retrieved 20 March 2021.
  2. ^ "Who we are". SAHPRA. Retrieved 20 March 2021.
  3. ^ 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.
  4. ^ "12 questions answered on the state of SAHPRA • Spotlight". Spotlight. 5 December 2018. Retrieved 20 March 2021.
  5. ^ "New vaccine trial starts in SA that targets 501Y.V2 – and it may include a booster pill". BusinessInsider. Retrieved 20 March 2021.
  6. ^ 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.
  7. ^ "'Can I close my eyes?' Ramaphosa has Covid-19 jab with Khayelitsha hospital staff". TimesLIVE. Retrieved 17 February 2021.
  8. ^ Writer, Staff. "South Africa approves Pfizer Covid-19 vaccine for emergency use". Retrieved 19 March 2021.