15 December 2020 With the advent of COVID-19, vaccine development is a critical area of need. SAHPRA has been proactive and is prepared for the vaccine registration process. The readiness programme includes the establishment of a specialised working group, the COVID-19 Vaccine Registration Working Group (CVr...
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...
12 November 2020 SAHPRA wishes to correct the inaccuracies in the Medical Brief article titled “High Court rules that SAHPRA not to regulate alternative medicines” published on 4 November 2020. On 01 October 2020, the Pretoria High Court delivered its judgment in the matter between the...
In collaboration with the South African Health Products Regulatory Authority (SAHPRA), Roche Products (Pty) Ltd would like to inform you of the risk of drug-induced liver injury (DILI) associ- ated with use of Esbriet® (pirfenidone): The Professional Information (PI) and Patient Information Leaflet (PIL) will be updated...
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 –...
SAHPRA alerts all healthcare professionals about the risk of serious heart problems, seizures, coma and death associated with the use of high doses of diphenhydramine- containing medicines. The South African Health Products Regulatory Authority (SAHPRA) wishes to alert healthcare professionals about the risk of serious heart...
20 October 2020 SAHPRA refutes claims made by the Black Farmers Association of South Africa (BFASA) that SAHPRA is a corrupt entity with an inclination towards White bias, in the issuing of licenses, generally and particularly with respect to cannabis products. SAHPRA is subject to inter...
The South African Health Products Regulatory Authority (SAHPRA), in collaboration with other regulatory agencies, are reviewing the final pharmaceutical products for immediate and extended release dosage forms containing metformin hydrochloride as an active substance. This review was triggered because of the detection of an impurity,...
