The COVID-19 pandemic is caused by SARS-CoV-2, a novel coronavirus that originated in Wuhan, China in late 2019. The virus has since spread around the world, with novel variants of concern causing new waves of infection. Testing is a critical component of COVID-19 control and...
This document is intended to provide communication to industry on nitrosamine review for all other new, in-process and registered products including biological medicines and all old medicines. This will be a “living document” and will be updated. It is important that Applicants adhere to the...
This document provides an overview of the safety regulatory decisions taken by SAHPRA on the safety concerns discussed during January – March 2022. This includes a summary of regulatory decisions, where safety concerns were reviewed and concluded, and those safety concerns that are not concluded...
This document sets out the proposed approach that SAHPRA undertakes to implement the process of medicine registration renewals ensuring a consistent approach to benefit all stakeholders to ensure quality, efficacious and safe products are available to the public....
Payment of Retention Fees for the Year Ending 31 December 2022 in respect of Medicines Registered up and until 31 December 2021 and/or Various Licences...
Please be informed that all documents and queries for GMP and CPP certificates should now be emailed to a new dedicated email address - see download. ...
The Medicines and Related Substances Act, 1965 (Act 101 of 1965) as amended, (“the Medicines Act”) makes provision for the payment of retention fees to the Regulatory Authority in respect of medicines, medical devices and IVDs registered and site licences issued. Further to the above, Regulation...
The COVID-19 pandemic is caused by SARS-CoV-2, a novel coronavirus that originated in Wuhan, China in late 2019. The virus has since spread around the world, with novel variants of concern causing new waves of infection....
2022 Mar...