Quality and Bioequivalence guideline

Previous version: 2.02 (V7)

This guideline is intended to provide recommendations to applicants wishing to submit new registration applications as well as variations. 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.