CTD for Drugs

Since the latest revision of the vaccine prequalification system, the global use of the common technical document (CTD) format has expanded substantially. The majority of manufacturers have generated a dossier in CTD format for product registration in one or more countries, and many countries that import prequalified medicines require submission of a dossier in CTD format for product registration.


Module 1 contains information not included in Modules 2, 3, 4 or 5 but that is required to assess the product for prequalification purposes. See below for further information and guidance.

Modules 2,3,4 and 5 share the common format and content of dossiers submitted to other authorities, according to the following major headings:

  • Module 02

    Common Technical Document Summaries (As per ICH guidelines M4Q, M4S, M4E)
  • Module 03

    Quality (as per ICH M4Q)
  • Module 04

    Nonclinical Study Reports (as per ICH M4S)
  • Module 05

    Clinical Study Reports (as per ICH M4E)

Follow us



7080, Southwest Fwy,
Houston, Texas – 77074