Other Guidelines
















PMTCT FOR MOTHERS 2019

  • 03 Jul 2020

This publication was supported under funding provided by the Global Fund to Fight AIDS, Tuberculosis and Malaria through the National Department of Health of South Africa and the NDoH Pharmacovigilance Centre for Public Health Programmes.


PMTCT FOR INFANTS 2019

  • 03 Jul 2020

This publication was supported under funding provided by the Global Fund to Fight AIDS, Tuberculosis and Malaria through the National Department of Health of South Africa and the NDoH Pharmacovigilance Centre for Public Health Programmes.






SAHPRA - general information

  • 15 Jul 2019

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines



SAHPRA - clinical guideline

  • 15 Jul 2019

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Human Medicines containing specified substances




SAHPRA - Submission in eCTD format

  • 15 Jul 2019

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration, as well as variations, of medicines in eCTD format.


SAHPRA - Submission in eSubmission format

  • 15 Jul 2019

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration, as well as variations, of medicines in eSubmission format.


SAHPRA - SA Guide to Good Manufacturing Practice

  • 15 Jul 2019

This document is intended to serve as guidance on the requirements for Good Manufacturing Practice (GMP) in South Africa. This guideline is not intended as an exclusive approach.


SAHPRA - New Registration Validation Template for eCTD

  • 15 Jul 2019

The Validation Template is used on receipt of an application to verify that all required information has been supplied to SAHPRA in order to evaluate an application for the new registration of a medicinal product for human use submitted in eCTD format.


SAHPRA - New Registration Validation Template for eSubmission

  • 15 Jul 2019

The Validation Template is used on receipt of an application to verify that all required information has been supplied to SAHPRA in order to evaluate an application for the new registration of a medicinal product for human use submitted in eSubmission format.


SAHPRA - Summary of Critical Regulatory Elements

  • 15 Jul 2019

The Summary of Critical Regulatory Elements (SCoRE) document is required for all new registration applications, to facilitate more rapid evaluation by SAHPRA, and should be submitted with new registration application at the time of filing.