Archive

This guideline is intended to provide recommendations to applicants wishing to submit amendments for registered BIOLOGICAL medicines. It represents SAHPRA’s current thinking on ensuring the safety, quality and therapeutic efficacy of medicines. It is not intended as an exclusive approach. SAHPRA reserves the right to...

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...

This document provides guidance on the procedures involved in the scheduling and conduct of Pre-Registration Consultation meetings between the Office of the Chief Regulatory Authority (CRO) of the South African Health Product Regulatory Authority (SAHPRA), and the applicant / sponsor for biological medicines. The primary...

This guideline is intended to provide guidance to applicants on the scheduling of substances submitted for registration as medicines. It represents the South African Health Products Regulatory Authority’s current thinking on the safety, quality and efficacy of medicines and takes into account the country’s obligations...

This document provides guidance to applicants regarding the acceptability of proposed proprietary names of products submitted for registration as medicines. It represents the current thinking of the South African Health Products Regulatory Authority [SAHPRA] on naming policy, how naming policy is intended to inform treatment...