This is a form to report ADRs in clinical trials....
SAHPRA has embarked on a process to digitalise its business processes. A pilot electronic process is in progress for new medicinal clinical trial applications from April 2026 and so far included May and June 2026 submission due dates....
Following the launch of the online applications form for CTF1 on the 7th of April and the constructive engagement on 13 April 2026, several enhancements discussed have now been implemented to improve the user experience. All enhancements went live this morning, enabling us to more...
This document is intended to provide communication to various stakeholders conducting Clinical Trials on allowed method for Serious Aderse Events (SAE) reporting to SAHPRA....
This document has been prepared as a guideline for preparing applications to conduct clinical trials in South Africa. It represents the South African Health Products Regulatory Authority’s (SAHPRA) current thinking on pregnancy and lactation for clinical research in South Africa. It is not intended as...
This document has been prepared to serve as a guideline for the preparation of applications to conduct first-in-human (FIH) and Phase I clinical trials in South Africa. It is not intended as an exclusive approach, and SAHPRA reserves the right to request any additional information...
This document has been prepared to serve as a guideline to clarify the requirements of insurance for those who conduct interventional clinical trials involving human participants and intend on making a submission for approval of a clinical trial by South African Health Products Regulatory Authority...
This document has been prepared to serve as a guideline for applicants/investigators who wish to submit the application to conduct a clinical trial, application for additional sites, and additional investigators for an approved trial....
This document has been archived....
This document has been archived....
