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....
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 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....
This document has been prepared to serve as a recommendation to those who wish to import and export medicines in South Africa. The South African Health Products Regulatory Authority (SAHPRA) is committed to ensure that all medicines entering or leaving the country will retain the...
This guideline provides recommendations for applicants seeking to submit an application for a licence to manufacture, import, or export a medicine or scheduled substance. It is not intended as an exclusive approach and should not be taken as a complete or authoritative statement of the...
This document has been prepared as a guidance document on the fees structure employed to calculate the fees for GxP and product related inspections....