Embargo: Immediate release SAHPRA has issued Section 21 authorisation for one serological test kit (rapid, point of care test kit) and five lab-based SARS-Cov-2 serology tests. For the rapid, point of care serology tests, the manufacturer is Zhejiang Orient Gene Biotech. There are seven licence holders for...
In the interest of public health, SAHPRA has launched the COVI-Vig reporting system for vigilanceand monitoring of health products being used for prevention or treatment of COVID-19 outside ofa clinical trial and outside of the MEURI framework. Under these circumstances, we are aware that a number...
The Backlog Clearance Programme has received applications for Re-submission Windows 1 to 9. The quality of submissions has improved significantly. We are receiving all applications submitted on the Document Uploading System via the FTP site and all queries from applicants regarding the FTP site are...
Business-As-Usual (BAU) process have been amended to be in line with new regulatory processes emanating from the Backlog Clearance Programme (BCP) pilot lessons and findings. BAU applications are those applications received by SAHPRA from 1st February 2018. This includes variation applications received from 1st February 2018, which...
In its 25 November 2019 communication to stakeholders about cannabis and related substances, SAHPRA drew attention to the 18 September 2018 decision of the Constitutional Court, which found sections of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) (the “Medicines and Related...
SAHPRA and B4SA under the Pharmaceutical and Vaccines working stream are collaborating on providing industry with regulatory guidance to ensuring essential Covid-19 related medicines supply in both the public and private sector are well managed in a clear and transparent manner. To this end, the regulatory...
30 March 2020 In line with the recommendation of the South African National Institute for Communicable Disease (NICD) and the recommendation of the World Health Organization (WHO), SAHPRA wishes to point out that the so-called Rapid test kits (serological test kits) that are being offered...
In line with the recommendation of the South African National Institute for Communicable Disease (NICD) and the recommendation of the World Health Organization (WHO), SAHPRA wishes to point out that the so-called Rapid test kits (serological test kits) that are being offered for the diagnosis...
The document in the link below has been prepared to serve as a guideline to healthcare professionals, reporting adverse drug reactions and product quality problems. It represents South African Health Products Regulatory Authority’s (SAHPRA’s) current thinking on the safety, quality and efficacy of medicines (including...
The World Health Organisation (WHO) has declared COVID-19 to be a Public Health Emergency of International Concern on 30 January 2020. On 14 March 2020, President Ramaphosa announced several steps to curb transmission and on 23 March 2020 further steps were announced. These steps reflect...
