This guideline is intended to provide recommendations to applicants wishing to submit new registration applications, as well as variations, for reliance review-based evaluation. It represents the South African Health Products Regulatory Authority’s (SAHPRA’s) current thinking on the safety, efficacy, and quality of medicines. It is...
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...
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)...
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....
This document has been archived....
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....
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...
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...
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...