10 December 2020 What is a Covid-19 Vaccine? A COVID‑19 vaccine is any of several different vaccine technologies intended to provide immunity against coronavirus disease 2019 (COVID‑19).1 In general, vaccines contain weakened or inactive parts of a particular organism (antigen) that triggers an immune response within the...
04 December 2020 Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus, SARS- CoV-2. The rapid spread of this virus has resulted in the COVID-19 pandemic that has led to a dramatic loss of human life worldwide and presents an unprecedented challenge...
19 November 2020 The Backlog Clearance Team has been made aware of a miscommunication in our Newsletter dated August 2020 and we would like to clarify the matter. It relates to the submission of Type I & II variation applications and states that Type I variations...
SAHPRA has implemented an application status checker. This new tool is listed under “Online Services” on the SAHPRA website. Accessing this tool will enable an applicant to check the status of their new health product(s) application. Please note that this tool is for Business-As-Usual applications only –...
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...
