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Guidance for Industry - Preparation of Drug Submissions in the eCTD Format

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Notice

Our file number: 05-120330-879

Release of Health Canada Guidance for Industry: Creation of the Canadian Module 1 eCTD Backbone File

Health Canada is please to announce the finalization of the Guidance for Industry: Creation of the Canadian Module 1 eCTD Backbone File. This guidance document outlines the creation of a regional backbone file according to the Canadian Module 1 Document Type Definition (DTD). This backbone file is to be used in the preparation and filing of drug submissions in the electronic Common Technical Document (eCTD) format established by the International Conference on Harmonization (ICH).

This guidance document is meant to be read in conjunction with:

Canadian DTD Version 1.0 for ICH Module 1 eCTD and
Guidance to Industry: Preparation of Submissions in the eCTD Format

The guidance document is being published after a 60-day consultation period with stakeholders, including industry representatives. Please note that no changes were made to the draft guidance document, as no comments were received from stakeholders.

The implementation and use of the eCTD format is a work in progress. Future refinements to this document will continue to be necessary as a result of experience gained during implementation and subsequent iterations will be released.

Any updates to eCTD filing requirements will only be introduced following advance consultation and notice, and will not be applied retroactively to submissions pending review. Furthermore, for submissions currently in preparation sponsors may continue to follow the Health Canada guidance documents in effect prior to the date of release of this notice. Subsequent submissions, however, should be compiled using the most recent guidance documents.

Should you have any questions regarding the content of the guidance documents, please contact:

ereview@hc-sc.gc.ca.

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Guidance for Industry

Creation of the Canadian Module 1 eCTD Backbone File

Published by authority of the Minister of Health

Date Adopted: 2004/06/15

Available in Canada through
Health Canada - Publications
Brooke Claxton Building, A.L. #0913A
Tunney's Pasture
Ottawa, Ontario
K1A 0K9

Tel: (613) 954-5995
Fax: (613) 941-5366

Catalogue No. E
ISBN

Foreword

Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with the policies and governing statutes and regulations. They also serve to provide review and compliance guidance to staff, thereby ensuring that mandates are implemented in a fair, consistent and effective manner.

Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate scientific justification. Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this guidance, in order to allow the Department to adequately assess the safety, efficacy or quality of a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable guidances.

Introduction
General Structure
- 2.1 Creating the Module 1 eCTD Backbone File
Common Elements
Leaf Elements
XML Elements
- 5.1 introduction Element
- 5.2 m1-administrative-information-and-prescribing-information Element
Naming Convention, File Formats and Folder Structure
Appendices

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1. Introduction

This guidance document outlines the creation of a regional backbone file according to the Canadian Module 1 Document Type Definition (DTD). This backbone file is to be used in the preparation and filing of drug submissions in the electronic Common Technical Document (eCTD) format established by the International Conference on Harmonization (ICH).

This guidance document is meant to be read in conjunction with the documents listed in Appendix A, "References."

2. General Structure

The Canadian Module 1 eCTD backbone file comprises three main components:

Common elements;
Leaf elements; and
Extensible Markup Language (XML) elements.

2.1 Creating the Module 1 eCTD Backbone File

To create the Module 1 eCTD backbone file:

Insert the common elements (outlined in Section 3.0) at the top of an XML file.
Insert the content of the Canadian Module 1 eCTD backbone file (outlined in sections 4.0 and 5.0) after the common elements and before the root element document end tag. The root element document end tag is always the same: </hcsc:ectd>. Note: All XML elements must have end tags (containing the name of the element).
Name the Canadian Module 1 eCTD backbone file ca-regional.xml and place it in the ca subfolder within the Module 1 (m1) subfolder.

3. Common Elements

The first three elements of the Canadian Module 1 eCTD backbone file are as follows:

Line 1:: The XML declaration that defines the version of XML and the character encoding used in the Canadian Module 1 eCTD backbone file.
Line 2:: The document type declaration that links the Canadian Module 1 DTD to the Canadian Module 1 eCTD backbone file.
Line 3:: The root element of the document.

Table 1: Example Common Elements

<?xml version="1.0" encoding="UTF-8"?>
<!DOCTYPE hcsc:ectd SYSTEM "../../util/ca-regional-1-0.dtd">
<hcsc:ectd xmlns:hcsc="http://www.hc-sc.gc.ca/hpb-dgps/therapeut/ectd" 
xmlns:xlink="http://www.w3c.org/1999/xlink">

4. Leaf Elements

The Canadian Module 1 eCTD backbone file includes document information for each Module 1 document. This information is provided within an XML leaf element. The leaf elements in the Module 1 eCTD backbone file are organized using XML heading elements, which are named and organized according to the subject matter of the documents.

Detailed information on leaf elements is provided in the ICH M2 EWG Electronic Common Technical Document Specification Version 3.2.

Table 2: Example Leaf Element

<leaf id="ca-1015" operation="new" 
checksum="03c9b86c625538001c5c5e73bbde5512" 
checksum-type="MD5" xlink:href="environment-assessment-report.pdf" 
xlink:type="simple">
	<title>1.5 Environmental Assessment Report</title>
</leaf>

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5. XML Elements

The XML elements in the Canadian Module 1 eCTD backbone file are organized under two main elements: 1) introduction element and 2) M1-administrative-information-and-prescribing-information element.

5.1 introduction Element

This information element contains the applicant, product-name and ectd-submission-info sub-elements.

Insert the introduction element within the hcsc:ectd element (i.e., after Line 3 of the common elements, above). Within the introduction element, create three XML sub-elements named as follows and in the following order:

applicant (see Section 5.1.1)
product-name (see Section 5.1.2)
ectd-submission-info (see Section 5.1.3)

Table 3: Example introduction Element

<introduction>
	<applicant>Sponsor</applicant>
	<product-name>drug name</product-name>
	<ectd-submission-info submission-type="NDS">
		<submission-identifier>HC identifier</submission-identifier>
		<sequence-number>0000</sequence-number>
		<submission-date>yyyy-mm-dd</submission-date>
	</ectd-submission-info>
</introduction>

5.1.1 applicant Sub-element

Insert the applicant sub-element within the introduction element as highlighted in Table 4, below. Include the sponsor's name in the applicant sub-element.

Table 4: Example applicant Sub-element

<introduction>
	<applicant>Sponsor</applicant>
		<product-name>drug name</product-name>
		<ectd-submission-info submission-type="NDS">
			<submission-identifier>
			HC identifier
			</submission-identifier>
			<sequence-number>0000</sequence-number>
			<related-sequence-number>xxxx</related-sequence-number>
			<submission-date>yyyy-mm-dd</submission-date>
		</ectd-submission-info>
</introduction>

5.1.2 product-name Sub-element

Insert the product-name sub-element within the introduction element as highlighted in Table 5, below. Insert the drug name in the product-name sub-element.

Table 5: Example product-name Sub-element

<introduction>
	<applicant>Sponsor</applicant>
	<product-name>drug name</product-name>
	<ectd-submission-info submission-type="NDS">
		<submission-identifier>HC identifier</submission-identifier>
		<sequence-number>0000</sequence-number>
		<related-sequence-number>xxxx</related-sequence-number>
		<submission-date>yyyy-mm-dd</submission-date>
	</ectd-submission-info>
</introduction>

5.1.3 ectd-submission-info Sub-element

This sub-element has an attribute that contains a value. Table 7 outlines the submission-type attribute and possible values for various types of eCTD submissions. This element also contains four additional sub-elements, described in sections 5.1.3.1 to 5.1.3.4.

Insert the ectd-submission-info sub-element within the introduction element as highlighted in Table 6, below.

Table 6: Example ectd-submission-info Sub-element

<introduction>
	<applicant>Sponsor</applicant>
	<product-name>drug name</product-name>
	<ectd-submission-info submission-type="NDS">
		<submission-identifier>HC identifier</submission-identifier>
		<sequence-number>0000</sequence-number>
		<related-sequence-number>xxxx</related-sequence-number>
		<submission-date>yyyy-mm-dd</submission-date>
	</ectd-submission-info>
</introduction>

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Table 7: Submission-Type Attribute and Possible Values¹
Submission Type	Attribute	Value
Clinical Trial Application	submission-type	"CTA"
Clinical Trial Application Amendment	submission-type	"CTA-A"
Investigational New Drug Submission - Veterinary Drugs	submission-type	"IND"
New Drug Submission	submission-type	"NDS"
Supplemental New Drug Submission	submission-type	"SNDS"
Abbreviated New Drug Submission	submission-type	"ANDS"
Abbreviated New Drug Submission - Veterinary Drugs	submission-type	"ABNDS"
Supplemental Abbreviated New Drug Submission	submission-type	"SANDS"
Supplemental Abbreviated New Drug Submission - Veterinary Drugs	submission-type	"ABSNDS"
Notifiable Change	submission-type	"NC"
Drug Identification Number Submission - All Types	submission-type	"DIN"
Administrative Manufacturer Name /Product Name Change/ Licensing Agreements	submission-type	"ADMIN"

¹ This table is not a complete listing of all submission types. A complete listing of submission types is provided in Health Canada's Guidance for Industry: Management of Drug Submissions. Health Canada does not currently accept all of the above submission types in eCTD format. Acceptable submission types are identified in Health Canada's Guidance to Industry: Preparation of Drug Submissions in the eCTD Format.

5.1.3.1 submission-identifier Sub-element

Insert the submission-identifier sub-element within the ectd-submission-info sub-element as highlighted in Table 8, below.

Table 8: Example submission-identifier Sub-element

< ectd-submission-info submission-type="NDS">
	<submission-identifier>HC identifier</submission-identifier>
	<sequence-number>xxxy</sequence-number>
	<related-sequence-number>xxxx</related-sequence-number>
	<submission-date>yyyy-mm-dd</submission-date>
</ectd-submission-info>

5.1.3.2 sequence-number Sub-element

The sequence-number sub-element for each submission filed in the drug product life cycle must contain a unique and incremental four-digit sequence number.

The sequence number for the first eCTD submission must be 0000. Sponsors are to provide a unique and incremental number for each subsequent submission. The sequence number should have the same value as the corresponding folder name under the main submission folder, as described in the ICH M2 EWG Electronic Common Technical Document Specification Version 3.2.

Insert the sequence-number sub-element within the ectd-submission-info sub-element as highlighted in Table 9, below.

Table 9: Example sequence-number Sub-element

< ectd-submission-info submission-type="NDS">
	<submission-identifier>HC identifier</submission-identifier>
	<sequence-number>0000</sequence-number>
	<submission-date>yyyy-mm-dd</submission-date>
</ectd-submission-info>

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5.1.3.3 related-sequence-number Sub-element

The related-sequence-number sub-element is an optional element. Insert one or more related-sequence-number sub-elements within the ectd-submission-info sub-element in the following two cases:

1. Drug product life cycle: If the current submission for a particular drug product is a Supplemental New Drug Submission (SNDS) submitted following a previous New Drug Submission (NDS), the related-sequence-number sub-element should contain the sequence number of the original NDS.

For example, if the sequence number for the SNDS is 0009 and the sequence number for the NDS is 0000, the related sequence number should be 0000, as highlighted in Table 10, below.

Table 10: Example related-sequence-number Sub-element (Case 1)

<ectd-submission-info submission-type="SNDS">
	<submission-identifier>HC identifier</submission-identifier>
	<sequence-number>0009</sequence-number>
	<related-sequence-number>0000</related-sequence-number>
	<submission-date>yyyy-mm-dd</submission-date>
</ectd-submission-info>

2. Submission life cycle: If a response is required in the course of the current submission process, the related-sequence-number
sub-element for this response should contain the sequence number of the current drug submission.

For example, if the sequence number for the SNDS is 0009 and the sequence number for the response is 0010, the related sequence number should be 0009, as highlighted in Table 11, below.

Table 11: Example related-sequence-number Sub-element (Case 2)

<ectd-submission-info submission-type="SNDS">
	<submission-identifier>HC identifier</submission-identifier>
	<sequence-number>0010</sequence-number>
	<related-sequence-number>0009</related-sequence-number>
	<submission-date>yyyy-mm-dd</submission-date>
</ectd-submission-info>

5.1.3.4 submission-date Sub-element

Insert the submission-date sub-element within the ectd-submission-info sub-element as highlighted in Table 12, below. Use the format yyyy-mm-dd to identify the submission date.

Table 12: Example submission-date Sub-element

< ectd-submission-info submission-type="NDS">
	<submission-identifier>HC identifier</submission-identifier>
	<sequence-number>0001</sequence-number>
	<related-sequence-number>0000</related-sequence-number>
	<submission-date>2004-01-15</submission-date>
</ectd-submission-info>

5.2 m1 - administrative - information - and - prescribing - information Element

The m1-administrative-information-and-prescribing-information element contains leaf elements and XML heading elements to organize all of the electronic documents submitted as part of Module 1.

This element contains four sub-elements and leaf elements. Each sub-element follows the structure outlined in Table 13, below, with the exception of the lowest level element in the hierarchy. The lowest level element contains only leaf elements without further sub-elements. For example, the m1-2-application-information element, the m1-3-product-labelling element, and the m1-4-hc-sc-summaries element contain sub-elements and leaf elements. The m1-5-environmental-assessment-statement element only contains leaf elements.

The use of leaf elements is optional at any element level, with the exception of the lowest level elements, which only include leaf elements. Do not include a lowest level element in the Canadian Module 1 eCTD backbone file without a leaf element. Higher level elements in the Canadian Module 1 eCTD backbone file can contain leaf elements and sub-elements.

Table 13 lists the sub-elements and corresponding document leaf for the M1-administrative-information-and-prescribing-information element. The start and end tags for each element are listed in the right column. If there are one or more sub-elements for an element, the end tag of the corresponding element occurs in the table row below the last relevant sub-element. For simplicity, leaf elements are not listed in the table. Additional sub-elements that do not appear in Table 13 should not be included.

Refer to Appendix C, "Sample Canadian Module 1 eCTD Backbone File," for examples of leaf elements.

Table 13: m1-administrative-information-and-prescribing-information Element
Document Leaf	XML Heading Elements and Sub-heading Elements
Patent List	<m1-2-4-patent-information> </m1-2-4-patent-information>
Good Manufacturing Practice and Establishment Licensing Information	<m1-2-5-gmp-and-establishment-licensing-information> </m1-2-5-gmp-and-establishment-licensing-information>
Letters of Access	<m1-2-6-letters-of-access> </m1-2-6-letters-of-access>
International Registration Status	<m1-2-7-international-registration-status> </m1-2-7-international-registration-status>
Other Application Information	<m1-2-8-other-application-information> </m1-2-8-other-application-information>
End Applicant Information	</m1-2-application-information>
Documents for Product Labelling	<m1-3-product-labelling>
Product Monograph	<m1-3-1-product-monograph> </m1-3-1-product-monograph>
Draft of all Inner and Outer Labels	<m1-3-2-draft-of-all-inner-and-outer-labels> </m1-3-2-draft-of-all-inner-and-outer-labels>
Non-Canadian Package Inserts	<m1-3-3-non-canadian-package-inserts> </m1-3-3-non-canadian-package-inserts>
End Product Labelling	</m1-3-product-labelling
Documents for Health Canada (HC)/Santé Canada (SC) Summaries	<m1-4-hc-sc-summaries>
Certified Product Information Document	<m1-4-1-certified-product-information-document> </m1-4-1-certified-product-information-document>
Bioequivalence Comprehensive Summary	<m1-4-2-comprehensive-summary-bioequivalence> </m1-4-2-comprehensive-summary-bioequivalence>
End HC/SC Summaries	</m1-4-hc-sc-summaries>
Environmental Assessment Statement	<m1-5-environmental-assessment-statement> </m1-5-environmental-assessment-statement>
End m1 - administrative prescribing - information element	</m1-administrative-information-and-prescribing-information>

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6. Naming Convention, File Formats and Folder Structure

This section provides guidance regarding the naming convention, file formats and folder structure to be applied to Canadian Module 1 files.

6.1 Naming Convention

The ICH M2 EWG Electronic Common Technical Document Specification Version 3.2 and Health Canada's Guidance for Industry: Preparation of Drug Submissions in the eCTD Format prescribe the naming convention to be applied to all submission files, with the exception of the Health Canada Drug Submission Application Form (HC/SC 3011). This form should be submitted in Portable Document Format (PDF) and should be named "hc-sc-3011-en.pdf" (English submission) or "hc-sc-3011-fr.pdf" (French submission).

Upon completion and release of the HC/SC 3011 DTD, Health Canada will accept the HC/SC 3011 Form as an XML file, to be named "hc-sc-3011-en.xml" (English submission) or "hc-sc-3011-fr.xml" (French submission).

6.2 File Formats

It is recommended that electronic documents conform to the file formats specified in Health Canada's Guidance for Industry: Preparation of Drug Submissions in the eCTD Format.

6.3 Folder Structure

All Canadian Module 1 files are to be placed in the ca subfolder. The ca subfolder must not include additional subfolders.

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7. Appendices

Appendix A: References

Health Canada Reference Documents:

Guidance for Industry: Preparation of Drug Submissions in the eCTD Format
HC SC 3011: Drug Application for: Human, Veterinary, or Disinfectant Drugs and Clinical Trial Applications/Attestation
Guidance for Industry: Management of Drug Submissions

The latest versions of Health Canada guidance documents, policies, templates and forms can be obtained from the Health Canada web site at <http://www.hc-sc.gc.ca/dhp-mps/index-eng.php> and at <http://www.hc-sc.gc.ca/dhp-mps/brgtherap/index-eng.php>. Sponsors are recommended to also visit the e-Review site at <http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/proj/e-rev-exam/index-eng.php>.

ICH Reference Documents:

ICH M2 EWG Electronic Common Technical Document Specification Version 3.2

This guidance, along with related guidance documents, information and Questions and Answers on eCTD implementation issues are available from the ICH web site at < www.ich.org>.