Guideline on the Quality and Clinical Aspects of Synthetic Peptides

This guideline provides recommendations to applicants who wish to submit application for the registration of synthetic peptide medicines. The South African Health Products Regulatory Authority (SAHPRA) is committed to the safety, quality and efficacy of medicines. This document should be regarded as recommendations not as the only method that is available.

SAHPRA reserves the right to request any additional and latest information at the time of evaluation to establish the safety, efficacy, and quality of a medicine. Alternative approaches may be used, however, they must be scientifically proven and technically justified. It is important that applicants adhere to the administrative requirements to avoid delays in the processing and evaluation of applications.