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...
Guideline for consultation meetings in clinical trials. This document has been prepared to serve as a guideline for preparation of applications to conduct clinical trials in South Africa.
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...
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...
This document highlights the importance of having emergency standard operating procedures in place during the conduct of clinical trial at sites and also includes...
This is a guideline on safety reporting during clinical trials in South Africa.
This document has been archived.
This document has been prepared to serve as a guideline to those who prepare and distribute Dear Healthcare Professional letters. It represents South African Health Products Regulatory Authority (SAHPRA) current thinking...
This document has been prepared to serve as a guideline to healthcare professionals reporting adverse drug reactions, adverse event following immunisations and product quality problems. It represents South African Health Products Regulatory Authority’s (SAHPRA’s) current thinking on the safety, quality and efficacy of medicines.
This document has been prepared to serve as a guidance document regarding SAHPRA requirements for lodging a complaint on Medicines and Medical Devices – Regulatory Compliance Unit.