Electronic Common Technical Document (eCTD) File

The Common Technical Document (CTD) is an internationally agreed upon format required by regulatory authorities for well-structured dossier applications for the registrations of medicines.

The International Conference on Harmonisation (ICH) developed the CTD regulatory submissions format in collaboration with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Japan’s Ministry of Health, Labour and Welfare. As the administrative agency over the current form of the CTD, ICH is responsible for steering and administering any future changes to the harmonised CTD guideline. A CTD file, a term that refers to any required and relevant document, file or piece of information that is required to be included in the dossier application, must be indexed into one of the five modules that comprise the CTD (or its electronic counterpart, the eCTD).

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