CTD and eCTD: Overview on the Recommended Format and Content for Marketing Application Submissions Short Course Overview

Introduction and Overview

•History of the ICH and CTD

•Major misconceptions about the CTD

•Format:  The CTD is all about format

•The critical relational of Module 2 summaries to Modules 3, 4, and 5

Module 1

•“Granularity” and general principles for documents

•Module 1:  Regional Administrative

    > Regional driven

    > Importance of administrative issues

    > Module 1 similarities and differences between FDA, EMEA, and JMHWL

Module 2; 2.4 and 2.5 Overviews

•Nonclinical Overview (2.4) format and content recommendations

•Clinical Overview (2.5) format and content recommendations

Module 2: 2.3 Quality Overall Summary (QOS)

•The ‘S’ is for drug substance and ‘P’ for drug product

•Recommended content for S and P subsections

•Accuracy and completeness

•QOS appendices and regional information

•ICH Quality guideline summaries

Module 2: 2.6 Nonclinical Written and Tabulated Summaries

•Preparation recommendations for and information included in 2.6 subsections

•What to do if a nonclinical study was not done

•Tabulated summaries for pharmacology, pharmacokinetics, and toxicology

•ICH Safety guideline recommendations

Module 2: 2.7 Clinical Summaries

•Preparation recommendations for and information to be included in 2.7 subsections

•Single core clinical study report (CSR) acceptable to all regulatory authorities

•Handling of multiple efficacy indications in the CTD

•Summarization of human safety results

•ICH Efficacy guideline summaries

Modules 3, 4, and 5

•Organization of Quality documentation in Module 3

•Organization of nonclinical reports in Module 4

•Organization of clinical reports and other documentation in Module 5

The eCTD for Electronic Filing

•Preparing regulatory submissions in electronic format

•The evolving eCTD specifications

•Critical need to interface with regulatory agencies