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