Articles

Guidance for The Submission of The South African CTD /eCTD – General & Module 1

The document describes how to organize applications based on the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines on the CTD. The CTD is currently only applicable to human, not veterinary, medicines.

This guideline describes the following points;

Module 1 – Administrative information and prescribing information
Module 2 – Summary of the dossier
Module 3 – Quality
Module 4 – Non-clinical study reports
Module 5 – Clinical study reports
European Union guidelines on quality, safety, and efficacy

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Interim Measures Pending Update of Variations Addendum

Medicines | South Africa

The Variations addendum (2.08_Variations Addendum for Human and Veterinary Medicines_June2020_v1.docx) has been withdrawn on 1 st September 2020 from the SAHPRA website for updates to some general aspects including administrative and quality variation coding.

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JORDAN Module 1 eCTD Specification Release Notes

Medicines | Jordan

This document lists and briefly describes the updates and fixed issues included in the release of
the Jordan Module 1 eCTD Specification version 1.1 compared to version. 1.0.2.

This article describes the following points;