This guideline is intended to provide recommendations to applicants wishing to submit multiple applications for the registration of medicines. It represents the South African Health Products Regulatory Authority’s (SAHPRA) current thinking on the safety, quality and efficacy of medicines. It is not intended as an...
This guideline is intended to provide recommendations to applicants wishing to submit clinical applications for the registration of veterinary medicines containing specified substances. In addition to this guideline, SAHPRA reserves the right to request any additional information to establish the quality, safety, and efficacy of...
This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of veterinary medicines. ...
This document has been prepared to serve as a guideline to enable the direct payment of fees into the bank account of SAHPRA. It must be read together with the relevant Fees Regulations and the General Information guideline....
This document has been prepared to serve as a guideline for applicants/investigators who wish to submit the application to conduct a clinical trial, application for additional sites, and additional investigators for an approved trial....
This guideline serves as a guide to applicants on the electronic submission process for major activities performed within Clinical Trials Unit (CTU)....
This document has been prep ared to serve as a guideline for applicants who wish to request a meeting with South African Health Products Regulatory...
This document has been prepared to serve as guidance to applicants/sponsors of clinical trials during the use of registered or unregistered medicines in approved clinical trials. It represents the South African Health Products Regulatory Authority’s (SAHPRA) current thinking on participant reimbursement during clinical trial participation...
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...