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06 Feb

Posted at 09:13h in

SAHPRA is committed to supporting regulatory convergence and harmonisation initiatives across the African continent to enhance timely access to quality, safe, and effective health products. In alignment with this goal, SAHPRA has implemented a reliance pathway utilising assessments conducted under the African Medicines Agency (AMA)...

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....

31 Oct

Posted at 14:48h in

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Human Medicines (Categories A and D) containing specified substances. Regarding Category D medicines, the guidance provided herein pertains to general content requirements. Any specific technical guidance indicated in...

29 Apr

Posted at 08:28h in

This document is intended to provide communication to industry on the changes of EDQM CEP and implementation of CEP 2.0 for all other new applications for orthodox medicines. This will be a “living document” and will be updated in line with changes observed from the...

26 May

Posted at 14:30h in

This form is to be completed by the applicant/holder of a certificate of registration/principal from whom the document was purchased for submission in South Africa, based on which party submitted the dossier to the RRA....

03 May

Posted at 14:24h in

This document is for use of all products including Biologics and veterinary products, where the information is not applicable for the specific molecule; indicate "N/A". Veterinary medicine applicants are advised to also refer to the VICH guidelines....