Guidelines to Clinical Trials in Pregnancy and Lactation

Guidelines to Clinical Trials in Pregnancy and Lactation

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 an exclusive approach, and SAHPRA reserves the right to request any additional information and may make amendments in keeping with the current knowledge.

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Document Number: SAHPGL-CEM-CT-13
Version: 1
Date Updated: 30/03/2026
File Type: www
Category: Guideline
Unit: Clinical Evaluations Management, Clinical Trials