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The Common Technical Document: Overviews and Summary Documents

  • Pieter H. Joubert
  • Silvia M. Rogers

Abstract

The agreement within the ICH on the Common Technical Document (CTD), a common format for applications to register new drugs, was a major step forward in the standardization and simplification of the approval process (see also Chap. 9) as well as the ICH website (http://www.ich.org/products/ctd.html). The CTD is the basis of the 4th multidisciplinary ICH guideline (M4). It allows the submission of a global dossier to the USA and the ICH member states. This section only highlights certain key elements of the CTD. For detailed information, the reader should refer to the actual ICH guidance documents.

Keywords

Medicinal Product Orphan Drug Package Insert Related Drug Solid Data 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Copyright information

© Springer-Verlag Berlin Heidelberg 2015

Authors and Affiliations

  • Pieter H. Joubert
    • 1
  • Silvia M. Rogers
    • 2
  1. 1.PHJ Consult Ltd.PangbourneUK
  2. 2.Mediwrite GmbHBaselSwitzerland

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