The Comprehensive Table of Contents Headings and Hierarchy document provides a structured format for organizing and submitting electronic submissions to the FDA.

Module 1 is region specific and Modules 2, 3, 4 and 5 are intended to be common for all regions. In July 2003, the CTD became the mandatory format for new drug applications in the EU and …

To avoid the need to generate and compile different registration dossiers, this guideline describes a format for the Common Technical Document that will be acceptable in all three regions.

Module 5 describes the format and organisation of the clinical data relevant to the application. This module is an EU CTD document adopted in Australia.

CTD Module 5 covers the Clinical Study Reports of the CTD. Similar to the other Modules, eCTD Module 5 has a specific structure and Table of Contents used.

Module 5: presents the clinical study reports (CSRs). structure and content are specified in the ICH M4E guidelines, which provide a specific placement of clinical study reports and related …

Jul 23, 2020 · Module 5, also known as the Efficacy module, indicates all the study reports and assessments that prove that the product shows efficacy for the target indication. This Module …

To avoid the need to generate and compile different registration dossiers, this guidance describes a format for the Efficacy section of the CTD that will be acceptable in all three regions.

Jan 2, 2025 · Module 5 of eCTD is about the clinical study reports. It contains the clinical data of all the clinical studies as a part of evaluation of the drug product. ICH M4E guideline specifies …

Feb 1, 2004 · Guidance on the organisation of the information to be presented in registration applications for new pharmaceuticals (including biotechnology-derived products). Keywords: …