Pre-clinical Testing Guidelines and Clinical Requirements for Phase I / First in Human (FIH) Studies

Pre-clinical Testing Guidelines and Clinical Requirements for Phase I / First in Human (FIH) Studies

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 and may make amendments in keeping with the knowledge that is current at the time.

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Document Number: SAHPGL-CEM-CT-12
Version: 1
Date Updated: 30/03/2026
File Type: www
Category: Guideline
Unit: Clinical Evaluations Management, Clinical Trials