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14 Apr

Posted at 15:13h in

These guidelines provide recommendations for manufacturers seeking to submit Plasma Master Files to support the quality of the starting materials for Plasma-Derived Medicinal Products (PDMP). These apply to applications for the registration or variations of PDMP. These guidelines emphasise the South African Health Products Regulatory...

18 Nov

Posted at 10:18h in

This document intends to provide clarity on SAHPRA’s Core Business Escalation procedure, to enable effective and efficient communication between SAHPRA and its stakeholders....

27 May

Posted at 16:11h in

This document is intended to provide guidance to applicants for lot release requirements for all human vaccines. This will be a “living document” and will be updated on a regular basis. It is important that applicants adhere to the prescribed requirements in order to avoid...

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...