Kindly note that this communication serves to communicate two (2) processes that the SAHPRA Pharmacovigilance (PV) unit has revised. You are urged to take note of these revisions....
This document is intended to provide communication to applicants and holders of authorities of activities regulated by the Hazardous Substances Act, Act 15 of 1993 and amended regarding the requirements for internal rules that must be drawn up terms of Regulation 7 of the Regulations...
COVID-19 Clinical Trials - Two-Weekly Progress Reports Pilot – Clinical Trial Applications...
As you may be aware, SAHPRA has embarked on a process to digitalise its business processes. A pilot electronic process is planned for new medicinal clinical trial applications for January 2024. The official launch of the system for all new medicinal clinical trial applications will...
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. ...
This communication is for Stakeholders to be aware of the South African Health Products Regulatory Authority (SAHPRA) Clinical Trials Committee meeting dates and the submission dates for the year of 2024. ...
This communication to industry refers to the Medical Device Unit and Radiation Control Unit publishing SAHPRA’s position on EU regulatory transition for medical devices from MDD/AIMDD/IVDD to MDR 2017/745 /IVDR 2017/746....
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. ...
We have in the past few weeks assisted several applicants that reached out to us, to retrieve old variations records attached to users that have been de-activated at an organisational level and we thought it best to issue this advice....
Your attention is drawn to the provisions of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) as amended, making provision for the payment of retention fees to the Regulatory Authority in respect of medicines, medical devices and IVDs registered and site licences...