3. Format of the Submission – the Common Technical Document (CTD)

Module 3:

• presents the chemistry, manufacturing, and controls reports for the product.
• full details of what should be included in Module 3 are provided in the ICH M4Q guideline.
• sections on both active substance and medicinal product are included.
• main headings:
  • 3.1 Table of contents of Module 3
  • 3.2 Body of data
  • 3.2S Active Substance
  • 3.2P+ Medicinal Product
  • 3.3 Literature references used in Module 3