Module 1 of CTD contains 'Environmental Risk Assessment'

Module 2 of CTD contains 'Information relating p to Orphan Market Exclusivity'

Module 1 contains 'Information relating to Pharmacovigilance'

Module 3 of CTD contains 'Quality Overall Summary'

Module 2 of CTD contains 'Nonclinical Overview' and 'Clinical Overview'

Module 4 of CTD contains 'Description of Manufacturing Process' and 'Process Controls'

Module 3 of CTD contains 'Controls of Critical Steps and Intermediates'

Module 4 of CTD contains 'Manufacturing Process Development'

Module 3 of CTD contains 'Container Closure System'

Module 2 of CTD contains 'Stability Summary and Conclusions'

Module 3 of CTD contains 'Description and Composition of the Drug Product'

Module 3 of CTD contains 'Validation of Analytical Procedures'

Module 4 of CTD contains 'Toxicology studies'

Module 5 of CTD contains 'Safety Pharmacology'

Module 4 of CTD contains 'Reports of Biopharmaceutic Studies'

Module 5 of CTD contains 'Reports of Studies Pertinent to Pharmacokinetics using Human Biomaterials'

Module 4 of CTD contains 'Reports of Human Pharmacokinetic (PK) Studies'

Module 5 of CTD contains 'Reports of Human Pharmacodynamic (PD) Studies'

The eCTD backbone is an XML file (Extensible Markup Language ) representing the structure of the submission, it includes links to files and other metadata such as check sum information. The schema for the XML is very rigid.