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


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

The Common Technical Document (CTD) is the internationally agreed format for the preparation of Marketing Authorisation Applications (MAAs) for a medicine to be submitted to regulatory authorities agreed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

In July 2003, the CTD became

  • the legally mandatory format for new medicine applications in the EU and Japan
  • the “strongly recommended” format in the US for NDAs submitted to the Food and Drug Administration (FDA)
  • the official standard for the dossier format accepted in ICH Observer countries (Canada, Switzerland) and in more and more countries and regions around the world.

The CTD:

  • determines the appropriate format to assemble all the Quality, Safety and Efficacy information required
  • describes the organisation of modules, sections and documents to be used in a regulatory dossier
  • is applicable for MA applications irrespective of the procedure (CP, MRP, DCP or NP) and of type of application (stand alone, generics etc.; see below 7. Types of Marketing authorisation applications)
  • is organised in five modules (modules 2 to 5 constitute the actual CTD; module 1 is different according to region
  • gives no information about the specific content of the different parts of a dossier (besides the overall scope given in the headers) and does not indicate which studies and data are required for a successful approval.

The CTD Triangle – a graphic representation of the CTD structure, decreasing detail towards the top

Fogure 1: The CTD Triangle. Adapted from https://www.ich.org/page/ctd