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25 Jan

Posted at 10:30h in

This document guides the requirements for Good Manufacturing Practice (GMP) in South Africa.  This guideline is not intended as an exclusive approach.  The South African Health Products Regulatory Authority (SAHPRA) reserves the right to request any additional information to establish the safety, quality, and efficacy...

25 Jan

Posted at 10:24h in

This guideline provides recommendations to applicants who intend to submit applications for the registration or authorisation of medicines intended to be available to those affected by a public health emergency. It represents the current thinking of the South African Health Products Regulatory Authority (the Authority)...

25 Jan

Posted at 10:20h in

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines and variations. It represents the Authority’s current thinking on medicines' safety, efficacy and quality. It is not intended as an exclusive approach....

25 Jan

Posted at 10:17h in

This document is intended to provide requirements to applicants wishing to submit applications for the registration of medicines in eCTD format. It reflects the current situation and will be regularly updated with changes in legislation and experience gained....

25 Jan

Posted at 10:15h 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. With respect to Category D medicines, the guidance provided herein is related to general content requirements. Any specific technical...

25 Jan

Posted at 10:13h 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. With respect to Category D medicines, the guidance provided herein is related to general content requirements. Any specific technical...

25 Jan

Posted at 10:08h in

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Human Medicines containing specified substances. In addition to this guideline, SAHPRA reserves the right to request any additional information to establish the safety, quality, and efficacy of a...

25 Jan

Posted at 10:04h in

This document provides recommendations to applicants wishing to submit applications for the variation of human and veterinary medicines. In addition to this guideline, SAHPRA reserves the right to request any additional information to establish the safety, quality and efficacy of a medicine in keeping with...