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