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26 Jan

Posted at 13:58h in

This document has been prepared to serve as a guidance to applicant/sponsors of clinical trials during the use of registered or unregistered medicines in approved clinical trials. It represents the South African Health Products Regulatory’s (SAHPRA) current thinking on participant re-imbursement during clinical trial participation...

26 Jan

Posted at 13:54h in

This guideline assists sponsors of clinical investigations in developing monitoring strategies and plans for investigational studies of medical products, including human medicine and biological products, medical devices, and combinations thereof. The overarching goal is to enhance human participant protection and the quality of clinical...

26 Jan

Posted at 13:52h in

This document has been prepared to serve as a guideline to sponsors/applicant and investigators providing investigational pro duct to participants during clinical trials. This...

26 Jan

Posted at 13:43h in

To all Applicants: Kindly note that COVID-19 Clinical Trial Applications do not follow the above predetermined submission due dates. They can be submitted to SAHPRA at any time. The last COVID-19 CTC meeting for 2022 is on the 09 December 2022 and the submission due...

26 Jan

Posted at 13:42h in

These guidelines have the purpose of providing researchers and other interested parties with clearly articulated standards of GCP in locally conducted research that address the local realities and contexts, to ensure that clinical trials involving South African human participants are designed and conducted according to...