Publication of final versions of various guidelines

05 Jul 2019

SAHPRA is pleased to announce the publication of multiple guidelines (including Tranche 1 and Tranche 2 documents). Thank you to industry for your comments, which were duly considered. Please note that the implementation date of the Professional Information (PI) and Patient Information Leaflet (PIL) Guidelines is contingent on regulation amendments currently out for comment. The implementation date of the Variations Addendum is contingent on the go-live of the Digital Variations Portal. Development of the portal is underway, and additional communication will follow. Timelines for submitting in eCTD and eSubmission format will be detailed in the Roadmap (2.26), an updated version of which will be published shortly. 

Guidelines

2.01_General information_ Jul19_v10
2.02_Quality and Bioequivalence Guideline_Jul19_v7
2.08_Variations Addendum for Human and Veterinary Medicines_Jul19_v1
2.09_Clinical Guideline_Jul19_v2
2.14_Guideline for Patient Information Leaflet for Human Medicines (Categories A and D)_Jul19_v2
2.16_Guideline for Professional Information for Human Medicines (Categories A and D)_Jul19_v2
2.23_Submission in eCTD format_Jul19_v3
2.58_Submission in eSubmission format_Jul19_v1
4.01_SA Guide to Good Manufacturing Practice_Jul19_v7
6.16_New Registration Validation Template for eCTD_Jul19_v3
6.30_New Registration Validation Template for eSubmission_Jul19_v1
6.31_Summary of Critical Regulatory Elements_Jul19_v1

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