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M2: eCTD Specification Questions and Answers and Change Requests March 2005

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This document provides guidance to applicants on how to use the electronic Common Technical Document (eCTD) specification. The guidance also answers questions that have been raised about the eCTD specifications and provides a change request table that tracks the status of all change requests that have been received by ICH since the eCTD specification was issued. The information provided here reflects the consensus of the ICH parties. The questions and answers (Q&As) and the change request table have been developed as a stand alone document that is available with this guidance. The document will be updated when the eCTD specification undergoes change control or new questions are submitted to the ICH.

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

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