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

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

(This section is organised in the form of a book, please follow the blue arrows to navigate through the book or by following the navigation panel on the right side of the page.)

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