Description - Figure 3 - Consultation Document - Draft Guidance Document: Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD)

Figure 3 illustrates a portion of the eCTD structure of a regulatory activity with multiple regulatory transactions (sequences).
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0000 is the Pre-submission meeting
1 is the administrative and product information
1.0 is the correspondence
1.0.1 is the cover letter
Cover letter Jan. 14, 2004 (new)
1.0.2 is the life cycle management table
LCM table (new)
1.0.3 is the meeting information
0001 is the meeting minutes
0002 is the priority review request
0003 is the new drug submission (NDS)
1 is the administrative and product information
1.0 is the correspondence
1.0.1 is the cover letter
Cover letter Jul. 04, 2004 (new)
1.0.2 is the life cycle management table
LCM table (replace)
1.0.3 is the copy of Health Canada issued correspondence
Priority review acceptance letter (new)
1.0.7 is the General note to reviewer
Note to reviewer (new)
1.2 is the administrative information
1.3 is the product information
1.4 are the Health Canada summaries
1.5 is the environmental assessment statement
1.6 is the regional clinical information
Module 2 to 5
0004 is the response to processing clarification
0005 is the response to notice of deficiency (NOD)
1 is the administrative and product information
1.0 is the correspondence
1.0.1 is the cover letter
Cover letter Jul. 04, 2005 (new)
1.0.2 is the Life cycle management table
LCM table (replace)
1.0.3 is the copy of Health Canada issued correspondence
Copy of NOD (new)
1.0.4 is the Health Canada solicited information
Response to NOD (new)
Section 1.2 to 1.6
Modules 2 to 5
Required documents (new/replace)