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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 recommendations to applicants wishing to submit applications for the registration of biosimilar medicines. It represents the South African Health Product Regulatory Authority’s current thinking on the safety, quality and efficacy of medicines. It is not intended as an exclusive...