13 Jul How COVID-19 vaccines are regulated for safety and effectiveness
Pixabay...
Author: Ntokozo Msiza
03 Jul SAHPRA AUTHORISES THE CORONAVAC VACCINE WITH CONDITIONS
03 July 2021 The South African Health Products Regulatory Authority (SAHPRA) has authorised the CoronaVac COVID-19 vaccine, manufactured by Sinovac Life Sciences Co, and imported by Curanto Pharma (Pty) Ltd. The authorisation was done in terms of Section 21 of the Medicines and Related Substance Act...
01 Jul Media release on the approval process of Covid vaccines
01 July 2021 The South African Health Products Regulatory Authority (SAHPRA) has reduced the time taken to register COVID-19 vaccines to less than three months where the required standard of data is available, while continuing to adhere to strict guidelines to ensure the safety of South...
25 Jun SAHPRA’s Response to the Economic Freedom Fighters (EFF) March
25 June 2021 The South African Health Products Regulatory Authority (SAHPRA) is an independent, science-based entity that follows strict guidelines and processes when approving health products. SAHPRA concerns itself, like other regulators across the world, with safety, quality and efficacy of health products. These essential requirements...
23 Jun SAHPRA and the Sinopharm Vaccine
23 June 2021 SAHPRA has received documentation for the Sinopharm vaccine developed by the China National Pharmaceutical Group in China. SAHPRA will now commence with evaluating the data in assessing the efficacy of the vaccine. Download PDF ...
21 Jun SAHPRA update on Vaccine Approvals
21 June 2021 The South African Health Products Regulatory Authority (SAHPRA) is an independent health products regulatory authority, governed by national legislation, whose mandate is to ensure the safety, quality and efficacy of health products available in South Africa. These essential requirements have been similarly applied...
13 Jun SAHPRA update COVID-19 Vaccine Janssen – FDA Developments
13 June 2021 SAHPRA registered the Covid-19 Vaccine Janssen on 31 March 2021, with conditions. The registration was done in terms of Section 15(6a) of the Medicines and Related Substance Act 101 of 1965. The Covid-19 Vaccine Janssen is an adenovirus type 26 vectored vaccine indicated for...
11 Jun SAHPRA Represented at A side event at the 30th Commission on Crime Prevention and Criminal Justice
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...
07 Jun SAHPRA update on the COVID-19 Vaccine Janssen – GMP Concerns
7 June 2021 SAHPRA registered the Covid-19 Vaccine Janssen on 31 March 2021, with conditions. The registration was done in terms of Section 15(6a) of the Medicines and Related Substance Act 101 of 1965. The Covid-19 Vaccine Janssen is an adenovirus type 26 vectored vaccine indicated for...
05 Jun Section 21 extension (Ventilators – invasive and non-invasive)
07 June 2021 To whom it may concern We draw your attention to the provisions of Section 21 of the Medicine and Related Substances Act, 1965 (Act 101 of 1965), to authorise the sale of unregistered medicines or medical devices for certain purposes. The communication...