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Obtain stakeholder information about the needs, challenges, investments necessary to implement the CTD and eCTD format. The Agency will use this information to plan the necessary transition time (voluntary adoption of the CTD and eCTD format) and ways to assist industry to achieve total adoption of the CTD and eCTD format.

This implementation guide is a supplemental document of the ICH eCTD v4.0 ICH Implementation Guide (hereafter referred to as "ICH IG"). This implementation guide describes a method for providing Japan specific information (e.g.: administrative information) which is required when creating eCTD v4.0 XML message instance and other components

This guidance document outlines the creation of a regional backbone file according to the Canadian Module 1 schema. This backbone file is to be used in the preparation and filing of drug regulatory transactions in eCTD format established by the International Conference on Harmonisation (ICH). 1.3 Scope and Application

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ICH: M4, The Common Technical Document, Implemented July 2003 For US submissions in the CTD or eCTD format, integrated analyses of safety are still required. In a CTD or eCTD, the ISS should be placed in Module 5, section 5.3.5.3. If the narrative portions of the ISS are suitable for use in Module 2 (section 2.7.4 of the CTD), then

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clinical trial applications, Orphan drug designations, PIP submissions and related submission correspondence. 2.2 Structure of Submissions This document provides guidance on how to organise application information for electronic submission using the eCTD specifications. Guidance on the detai

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