Biological medicines stability Guideline

This guideline is intended to give guidance to applicants regarding the type of stability that should be provided in support of the shelf-life of the biological medicines. It represents SAHPRA current thinking on the safety, quality and efficacy of the biological medicines. This guideline is not intended as an exclusive approach. SAHPRA reserves the right to request any additional information that may be deemed necessary to establish the safety, quality and efficacy of a biological medicine in keeping with the knowledge that is current at the time of evaluation. Alternative approaches may be used but these should be scientifically and technically justified. SAHPRA is committed to ensure that, all registered medicines are of the required quality, safety and efficacy. It is therefore important that applicants adhere to all the administrative requirements to avoid delays in the processing and evaluation of applications. This guideline is adopted from ICH Q5C guideline with minor modification. Guidelines and application forms are available from the office of the CEO and on SAHPRA website.