General guidance document on QSE for Biological Medicines

This guideline is intended to provide guidance to applicants wishing to submit new application for registration of biological medicines. It represents the Authority’s current thinking on the safety, efficacy and quality of medicines. It is not intended as an exclusive approach. SAHPRA reserves the right to request any additional information to establish the safety, efficacy and quality of a medicine in keeping with the knowledge current at the time of evaluation. Alternative approaches may be used but these should be scientifically and technically justified. The Authority is committed to ensure that all registered medicines will be of the required safety, efficacy and quality. It is important that applicants adhere to the administrative requirements to avoid delays in the processing and evaluation of applications..

Guidelines and application forms are available from the office of the Chief Executive Officer and the website.