Guidance for Industry M2: eCTD Specification Questions & Answers and Change Requests [PDF version] Additional copies are available from: Office of Training and Communication Division of Drug Information, HFD-240 Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 (Tel) 301-827-4573 http://www.fda.gov/cder/guidance/index.htm Office of Communication, Training and Manufacturers Assistance, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike,Rockville, MD 20852-1448 http://www.fda.gov/cber/guidelines.htm. (Tel)800-835-4709 or 301-827-1800 U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) March 2005 ICH TABLE OF CONTENTS INTRODUCTION BACKGROUND QUESTIONS AND ANSWERS AND CHANGE REQUESTS Guidance for Industry1 M2: eCTD Specification Questions & Answers and Change Requests This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. INTRODUCTION 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. FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. Table of Contents BACKGROUND The ICH guidance M2: eCTD: Electronic Common Technical Document Specification2 was endorsed by the ICH in September 2002 and issued by the FDA in April 2003. The eCTD specification is intended to assist industry in the electronic transfer of their marketing applications for human drug and biological products to a regulatory authority. The guidance defines the means for industry-to-agency transfer of regulatory information that will facilitate the creation, review, life cycle management, and archiving of the electronic submission. Table of Contents QUESTIONS AND ANSWERS AND CHANGE REQUESTS The ICH has received a number of questions with regard to the eCTD specification. In addition, some of the questions posed to the ICH address change requests to the eCTD specification. Questions and answeres to the questions (Q&As) and change requests are maintained by the ICH eCTD Implementation Working Group (IWG). A change request tracking table has been created to allow the public to monitor the status of all change requests. This table reflects all change requests that have been presented to the eCTD IWG and shows the status of the requests as: (1) out of scope, (2) approved for the next change to the eCTD specification, (3) approved but not requiring eCTD specification changes; therefore can be put in the Q&As, (4) deferred until a later date, (5) assigned for testing by the eCTD IWG, or (6) rejected. The ICH updates the Q&As and change request tracking table periodically. The most recent versions of the Q&As and table are provided in a separate companion document available on the Internet with this guidance. Table of Contents 1 This guidance was developed within the M2 eCTD Implementation Working Group of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and has been subject to consultation by the regulatory parties, in accordance with the ICH process. This document has been endorsed by the ICH Steering Committee at Step 4 of the ICH process, November 11, 2003. At Step 4 of the process, the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan, and the United States. 2 The M2: eCTD Specification guidance and this Q&A guidance are available on the Internet at http://www.fda.gov/cder/guidance/index.htm.

Updated May 17, 2004

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