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....
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...
This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Human Medicines (categories A and D) containing specified substances. With respect to Category D medicines, the guidance provided herein is related to general content requirements. Any specific technical...
This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Human Medicines (categories A and D) containing specified substances. With respect to Category D medicines, the guidance provided herein is related to general content requirements. Any specific technical...
This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Human Medicines containing specified substances. In addition to this guideline, SAHPRA reserves the right to request any additional information to establish the safety, quality, and efficacy of a...