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This document has been archived....
This document has been archived....
This document intends to provide clarity on SAHPRA’s Core Business Escalation procedure, to enable effective and efficient communication between SAHPRA and its stakeholders....
Applicants are advised to submit clinical trial applications before the due date. Applicants submitted after the due date will not be accepted....
This communication is issued in view that SAHPRA has embarked on a process to digitalise its business processes and need to pilot the electronic process. The pilot is planned for new medicinal clinical applications for the month of October 2025, with the official launch of...
This communication is issued given the current uncertainty about US government funding for healthcare in South Africa, particularly in clinical research, and it intends to emphasise the responsibilities of various stakeholders in Clinical Trials....
This communication is for Stakeholders to be aware of SAHPRA's Clinical Trials Committee meeting dates and the submission dates for the year of 2025. ...
This communication is intended to provide guidance to Applicants about investigational product import licences (clinical trial approval letters) that have been approved by the Department of Health (Medicines Control Council - MCC)....