Guidance for Industry

M2: eCTD Specification

Questions & Answers 

and Change Requests

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

March 2005

ICH
 

 


 


 

 



 

 



 


 


 

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Guidance for Industry

M2: eCTD Specification

Questions & Answers and

Change Requests
 

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

and/or

 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) Voice Information System at 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

March 2005

ICH
Contains Nonbinding Recommendations

TABLE OF CONTENTS 

I. INTRODUCTION................................................................................................................. 1
 

II. BACKGROUND ................................................................................................................... 2
 

III. QUESTIONS AND ANSWERS AND CHANGE REQUESTS ........................................ 2
 
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Contains Nonbinding Recommendations 

Guidance for Industry1

M2: eCTD Specification

Questions and 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. 

I. 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. 

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. 

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Contains Nonbinding Recommendations

II. 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. 

III. 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 answers 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. 

2 The M2: eCTD Specification guidanceand this Q&A guidance are available on the Internet at 

http://www.fda.gov/cder/guidance/index.htm. 

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