South African Health Products Regulatory Authority
April 12, 2024
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]
South African Health Products Regulatory Authority
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]
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]
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)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 Janssen vaccine for full section 21 mass use.[8]
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 [9]
Ivermectinedit
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]
^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. PMC6300068. PMID 30618735.
^"12 questions answered on the state of SAHPRA • Spotlight". Spotlight. 5 December 2018. Retrieved 20 March 2021.
^"New vaccine trial starts in SA that targets 501Y.V2 – and it may include a booster pill". BusinessInsider. Retrieved 20 March 2021.
^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.
^"'Can I close my eyes?' Ramaphosa has Covid-19 jab with Khayelitsha hospital staff". TimesLIVE. Retrieved 17 February 2021.
^Staff Writer. "South Africa approves Pfizer Covid-19 vaccine for emergency use". Retrieved 19 March 2021.
^"Section 21 Access to Unregistered Medicines: IVERMECTIN CONTROLLED COMPASSIONATE USE PROGRAMME" (PDF). 28 January 2021.
^"SAHPRA statement on the termination of the "Ivermectin Controlled Compassionate Use Access Programme"" (PDF).
south, african, health, products, regulatory, authority, sahpra, organisation, charge, regulating, health, products, throughout, country, part, national, department, health, company, typegovernment, companyindustrymedical, regulationheadquartersgauteng, south,. 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 South African Health Products Regulatory AuthorityCompany typeGovernment companyIndustryMedical RegulationHeadquartersGauteng South AfricaArea servedSouth AfricaRevenueR261 6 million 2 Operating incomeR308 3 million 2 Total assetsR45 06 million 2 Websitewww wbr sahpra wbr org wbr zaSAHPRA 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 Contents 1 History 2 Covid 19 2 1 Vaccines 2 1 1 Oxford AstraZeneca AZD1222 2 1 2 Johnson amp Johnson Ad26 COV2 S 2 1 3 Pfizer BioNTech BNT162b2 2 2 Ivermectin 3 See also 4 Notes 5 External links 6 ReferencesHistory editAs 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 editVaccines edit Main article COVID 19 vaccination in South Africa Oxford AstraZeneca AZD1222 edit 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 amp 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 Janssen vaccine for full section 21 mass use 8 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 9 Ivermectin edit 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 editCOVID 19 vaccine COVID 19 pandemic COVID 19 pandemic in South Africa COVID 19 vaccination in South AfricaNotes editExternal links editSAHPRA WebsiteReferences edit Who we are SAHPRA Archived from the original on 30 June 2023 Retrieved 30 June 2023 a b c SAHPRA 2020 Report PDF sahpra Retrieved 20 March 2021 Who we are SAHPRA Retrieved 20 March 2021 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 12 questions answered on the state of SAHPRA Spotlight Spotlight 5 December 2018 Retrieved 20 March 2021 New vaccine trial starts in SA that targets 501Y V2 and it may include a booster pill BusinessInsider Retrieved 20 March 2021 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 Can I close my eyes Ramaphosa has Covid 19 jab with Khayelitsha hospital staff TimesLIVE Retrieved 17 February 2021 Staff Writer South Africa approves Pfizer Covid 19 vaccine for emergency use Retrieved 19 March 2021 Section 21 Access to Unregistered Medicines IVERMECTIN CONTROLLED COMPASSIONATE USE PROGRAMME PDF 28 January 2021 SAHPRA statement on the termination of the Ivermectin Controlled Compassionate Use Access Programme PDF nbsp This article about South African government is a stub You can help Wikipedia by expanding it vte Retrieved from https en wikipedia org w index php title South African Health Products Regulatory Authority amp oldid 1177396088, wikipedia, wiki, book, books, library,
