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14 Apr

Posted at 10:18h in

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...

24 Jan

Posted at 12:51h in

This guideline document is intended to provide recommendations to applicants wishing to submit applications for the registration of biosimilar medicines. It represents the South African Health Product Regulatory Authority’s (SAHPRA) current thinking on the safety, quality, and efficacy of medicines. It is not intended as...

24 Jan

Posted at 12:49h in

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...

24 Jan

Posted at 12:47h in

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...

24 Jan

Posted at 12:40h in

This guideline document is intended to provide recommendations to applicants wishing to submit applications for the registration of Biosimilar Medicines. It represents the South African Health Product Regulatory Authority’s (SAHPRA) current thinking on the safety, quality, and efficacy of medicines. It is not intended as...