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 
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) 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 
Contains Nonbinding Recommendations 

1

Guidance for Industry1 1 

2 

3 M2: eCTD Specification 

4 

5 Questions and Answers and Change Requests 

6 

7 

8 

9 

10 

11 

12 This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It 

13 does not create or confer any rights for or on any person and does not operate to bind FDA or the public. 

14 You can use an alternative approach if the approach satisfies the requirements of the applicable statutes 

15 and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for 

16 implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate 

17 number listed on the title page of this guidance. 

18 

19 

20 

21 

22 

23 I. INTRODUCTION 

24 

25 This document provides guidance to applicants on how to use the electronic Common Technical 

26 Document (eCTD) specification. The guidance also answers questions that have been raised 

27 about the eCTD specifications and provides a change request table that tracks the status of all 

28 change requests that have been received by ICH since the eCTD specification was issued. The 

29 information provided here reflects the consensus of the ICH parties. The questions and answers 

30 (Q&As) and the change request table have been developed as a stand alone document that is 

31 available with this guidance. The document will be updated when the eCTD specification 

32 undergoes change control or new questions are submitted to the ICH. 

33 

34 FDA's guidance documents, including this guidance, do not establish legally enforceable 

35 responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should 

36 be viewed only as recommendations, unless specific regulatory or statutory requirements are 

37 cited. The use of the word should in Agency guidances means that something is suggested or 

38 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.
Contains Nonbinding Recommendations 

2

39 II. BACKGROUND 

40 

The ICH guidance M2: eCTD: Electronic Common Technical Document Specification2 41 was 

42 endorsed by the ICH in September 2002 and issued by the FDA in April 2003. The eCTD 

43 specification is intended to assist industry in the electronic transfer of their marketing 

44 applications for human drug and biological products to a regulatory authority. The guidance 

45 defines the means for industry-to-agency transfer of regulatory information that will facilitate the 

46 creation, review, life cycle management, and archiving of the electronic submission. 

47 

48 

49 III. QUESTIONS AND ANSWERS AND CHANGE REQUESTS 

50 

51 The ICH has received a number of questions with regard to the eCTD specification. In addition, 

52 some of the questions posed to the ICH address change requests to the eCTD specification. 

53 Questions and answers to the questions (Q&As) and change requests are maintained by the ICH 

54 eCTD Implementation Working Group (IWG). 

55 

56 A change request tracking table has been created to allow the public to monitor the status of all 

57 change requests. This table reflects all change requests that have been presented to the eCTD 

58 IWG and shows the status of the requests as: (1) out of scope, (2) approved for the next change 

59 to the eCTD specification, (3) approved but not requiring eCTD specification changes; therefore 

60 can be put in the Q&As, (4) deferred until a later date, (5) assigned for testing by the eCTD 

61 IWG, or (6) rejected. 

62 

63 

64 _______________ 

65 

66 

67 The ICH updates the Q&As and change request tracking table periodically. 

68 The most recent versions of the Q&As and table are provided in a separate 

69 companion document available on the Internet with this guidance. 

70 

 

2

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

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