eCTD/CTD (Common technical document)

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The Common Technical Document (CTD) is a set of specification for application dossier for the registration of Medicines and designed to be used across Europe, Japan and the United States. It is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries. The Common Technical Document is divided into five modules:

  • Administrative and prescribing information
  • Overview and summary of modules 3 to 5
  • Quality (pharmaceutical documentation)
  • Preclinical (Pharmacology/Toxicology)
  • Clinical – efficacy and safety (Clinical Trials)
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