Notice - Guidance Document: Creation of the Canadian Module 1 Backbone

September 7, 2012

On this page:

Notice

Our file number: 12-115151-181

Re: Guidance for Industry: Creation of the Canadian Module 1 Backbone

Health Canada is pleased to announce the finalization of the Guidance Document: Creation of the Canadian Module 1 Backbone as a result of a 30 day consultation period.  This document replaces the 2004 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 schema.  The Canadian Module 1 Schema files are to be used in the preparation and filing of drug regulatory activities in the electronic Common Technical Document (eCTD) format established by the International Conference on Harmonisation (ICH).

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

  • Canadian Module 1 Schema Version 2.2;and
  • Draft Guidance for Industry: Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD) Format.

It should be noted that, although Clinical Trial Applications (CTA) and Drug Master Files (DMFs) are included in the schema, they are not yet accepted in the eCTD format.  Please consult the Guidance for Industry: Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD) Format as well as the most recently published notices regarding eCTD regulatory activities to verify the scope of regulatory activities accepted in the eCTD format.

At this time Health Canada implementation is as per the following schedule:

  • As of September 30th, 2012, Health Canada will be accepting regulatory activities built using the revised Canadian Module 1 Schema Version 2.2.
  • As of March 31st, 2013, Health Canada will no longer be accepting regulatory activities built with the old Canadian Module 1 DTD.

Questions and comments relating to this document should be submitted, preferably in electronic format, to:

Office of Submissions and Intellectual Property (OSIP)
Therapeutic Products Directorate
Health Canada
Finance Building 2
Address Locator 0201A1
101 Tunney's Pasture Driveway
Ottawa, Ontario
K1A 0K9

Telephone: 613-957-3123
Fax: 613-941-0825
Email: eReview@hc-sc.gc.ca

Guidance Document: Creation of the Canadian Module 1 Backbone

Date Adopted 2004/06/15
Revised Date 2012/08/03
Effective Date 2012/09/30

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 guidance documents.

Table of Contents

1 Introduction

1.1 Policy Objective

To ensure sponsors have access to all the information needed to provide a drug dossier to Health Canada in electronic Common Technical Document (eCTD) format.

1.2 Policy Statement

This guidance document outlines the creation of a regional backbone file according to the Canadian Module 1 schema.  This backbone file is to be used in the preparation and filing of drug regulatory transactions in eCTD format established by the International Conference on Harmonisation (ICH).

1.3 Scope and Application

This Guidance document applies to all regulatory activities being provided to Health Canada in eCTD format.  This guidance document is meant to be read in conjunction with the documents listed in Appendix A, AReferences".

1.4 Background

The original Canadian Module 1 DTD (v1.0) was released in May 2004, well before Health Canada began receiving large numbers of regulatory activities in eCTD format.  Since that time, both industry and Health Canada have learned much about using the eCTD format.  Health Canada has also revised the Module 1 structure in the CTD format, and would now like to apply these revisions to the Module 1 (m1) specifications.  Given the desire to adopt the eCTD v4.0 / Regulated Product Submissions (RPS) in the foreseeable future, the decision has been made to move to a World Wide Web Consortium (W3C) Schema approach to define the updated M1 as outlined in the Guidance for Industry: Preparation of Drug Regulatory Activities in eCTD Format.

It is understood that this will not be the last time that the m1 specification will change.  It is expected that further work in this area will be required; however it should be noted that any future changes will be accompanied by a well thought out introduction to minimize the impact on industry (introduced at scheduled interval to allow stability).

2 Preparing the Canadian Module 1 Backbone File

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

  • A fixed 'eXtensible Markup Language' (XML) Declaration;
  • The eCTD Regulatory Transaction Information (metadata); and
  • The eCTD Table of Contents describing the actual files provided.

2.1 Creating the Module 1 electronic Common Technical Document (eCTD) Backbone File for a Given Regulatory Transaction (Sequence)

To create the Canadian Module 1 backbone file for a given regulatory transaction:

  1. Create an XML file with the appropriate XML declaration using an authenticated eCTD preparation software.  See "Preparing the XML Declaration" below.
  2. Create an <ectd-regulatory-transaction-information> element containing the appropriate metadata values describing this regulatory transaction. See "Preparing the eCTD Regulatory Transaction Information" below.
  3. Create an <m1-administrative-and-product-information> element containing additional elements as needed for this regulatory transaction, as described in "Preparing the eCTD Table of Contents" below. These elements will be of two broad types:
    • Heading elements, organizing the content in the Module 1 to meet Health Canada's review requirements.
    • Leaf elements, providing a file system reference to each file being submitted in the regulatory transaction as part of Module 1, along with other information such as eCTD check-sum and life-cycle information.
  4. Name the Canadian Module 1 eCTD backbone file "ca-regional.xml" and place it in the "ca" subfolder within the Module 1 ("m1") subfolder of the regulatory transaction.
  5. Validate the resulting backbone using a suitable eCTD Validation tool.

3 Preparing the Extensible Markup Language (XML) Decleration

All Canadian Module 1 backbone files prepared for Health Canada will contain the standard XML declaration as illustrated in Figure 1 below. Note that the required text includes both line 1 (identifying the file as an XML file) and the root element <hcsc_ectd> on line 2 with its attributes linking this XML file to the XML definition prepared by Health Canada.

Figure 1: Example showing XML Declaration

Declaration: Figure 1 indicates the standard XML declaration contained in all Canadian Module 1 backbone files prepared for Health Canada. 
1 <?xml version="1.0" encoding="utf-8"?>
2 <hscs_ectd schema-version=”2.2” xsi:schemaLocation=”hcsc_ectd../../util/dtd/ca-regional-2-2.xsd”
3 xmlns="hcsc_ectd" xmlns:xsi=http://www.w3.org/2001/XMLSchema-instance
4 xmlns:xlink=http://www.w3.org/1999/xlink>
5 <ectd-regulatory-transaction-information>
16 <m1-administrative-and-product-information>
246 </hcsc_ectd>

4 Extensible Markup Language (Xml) Elements

4.1 Preparing the electronic Common Technical Document (eCTD) Regulatory Transaction Information

The eCTD Regulatory Transaction Information section allows information about the regulatory activity and regulatory transaction to be included in a form which is easily processed.  This information, broadly categorized as metadata, allows Health Canada to more effectively manage incoming electronic regulatory activity and lowers the possibility of errors introduced by manually re-entering this key data.

Most of the elements in this section are required for all regulatory transaction sent to Health Canada.  This document provides an overview of expected content from a technical perspective.

Figure 2 shows all possible elements in this section defined by the <ectd-regulatory-transaction-information> element, in the required order.  This is followed by an element by element description of the expected content.  This description includes any schema imposed constraints [that is (i.e.) content rules] for the element.  This refers to rules built into the schema itself, which will be enforced by most XML tools.  It is important to note that this is separate from the eCTD validation, which the Sponsor should and Health Canada will perform using a dedicated validation tool.  This schema validation is considered to be at a lower level and at an earlier point than the eCTD validation.

Figure 2: Example showing Element

Figure 2 is an example showing <electronic common technical document (ectd)-regulatory-transaction-information> Element: Figure 2 shows all possible elements in this section defined by the <ectd-regulatory-transaction-information> element, in the required order.  This is followed by an element by element description of the expected content.  This description includes any schema imposed constraints [that is (i.e.) content rules] for the element.  This refers to rules built into the schema itself, which will be enforced by any reasonable XML tool.  It is important to note that this is separate from the more sophisticated validation which Health Canada may perform using other tools.  This schema validation is considered to be at a lower level and at an earlier point than the business validation which is performed when the sequence arrives at Health Canada.

3 <ectd-regulatory-transaction-information>
4 <applicant>My Company</applicant>
5 <product-name>My Product</product-name>
6 <dossier-identifier>e990001</dossier-identifier>
7 <dossier-type>Pharmaceutical Dossier </dossier-tipe>
8 <regulatory-activity-type>NDS</regulatory-activity-type>
9 <regulatory-activity-lead>Pharmaceutical</regulatory-activity-lead>
10 <sequence-number>0001</sequence-number>
11 <sequence-description>UnDefined Regulatory Transaction</sequence-description>
12 <related-sequence-number>0000</related-sequence-number>
13 </ectd-regulatory-transaction-information>

4.1.1 The <applicant> Element

This mandatory element contains the sponsor's name, i.e. the company which is submitting this regulatory transaction.  This element cannot be repeated.  There are no schema-level constraints (i.e. content rules) on this element.  Great care should be taken to ensure accuracy and consistency with this content.  For example, the values "My Company" or "My Company, Inc." or "My Company, Inc" are all different which may cause difficulties or delays in the processing of the regulatory transaction.

4.1.2 The <product-name> Element

This mandatory element contains the drug name, i.e. the product which is being addressed in this application.  This element cannot be repeated.  There are no schema-level constraints (i.e. content rules) on this element. Great care should be taken to ensure accuracy and consistency with this content.  For example, the values "My Product" or "My product" or "My Product" (note the double space!) are all different which may cause difficulties or delays in the processing of the regulatory transaction.

4.1.3 The <dossier-identifier> Element

This mandatory element contains the unique identifier assigned to this dossier by Health Canada. This element cannot be repeated.  It must be in the format "e999999", i.e. a lower case letter followed by six digits.  It is expected that the sponsor will acquire a valid dossier identifier from Health Canada before submitting the initial regulatory transaction.

4.1.4 The <dossier-type> Element

This mandatory element contains the type of dossier, i.e. from a simplistic perspective, whether it is a pharmaceutical or biologic regulatory activity.  This element cannot be repeated. The content of this element is taken from a list of values defined by Health Canada and listed in the table below.

Table 1: Dossier Type
Biologic Dossier
Includes all regulatory activities under the Biologics and Genetic Therapies Directorate (BGTD) mandate.
Pharmaceutical Dossier
Includes all regulatory activities under the Therapeutic Products Directorate (TPD) mandate.
Drug Master File Dossier
Includes all regulatory activities under the TPD-Bureau of Pharmaceutical Science (BPS), BGTD, Natural Health Products Directorate (NHPD), and Veterinary Drugs Directorate (VDD) mandates as defined in the Draft Guidance Document - Drug Master Files (DMFs)
4.1.5 The <regulatory-activity-type> Element

This mandatory element contains the type of the regulatory activity, i.e. from a simplistic perspective, what regulatory purpose this filing is addressing. This element cannot be repeated. The content of this element is taken from a list of values defined by Health Canada and listed in Table 2 below.

Table 2: Regulatory Activity Type
NDS
New Drug Submission
SNDS
Supplement to a New Drug Submission
SNDS-C
Supplement to a New Drug Submission - Conditional
ANDS
Abbreviated New Drug Submission
SANDS
Supplement to an Abbreviated New Drug Submission
NC
Notifiable Change
CTA
Clinical Trial Application
CTA-A
Clinical Trial Application - Amendment
DINA
Drug Identification Number Application
DINB
Drug Identification Number - Biologics
PDC
Post DIN Change
PDC-B
Post DIN Change - Biologics
PSUR-C
Periodic Safety Update Report - Conditional
PSUR-PV
Periodic Safety Update Report - Pharmacovigilance
UD-PV
Undefined Data Pharmacovigilance
RMP-PV
Risk Management Plan - Pharmacovigilance
Level III
Post-Notice of Compliance Changes - Level III
YBPR
Yearly Biologic Product Report
MPNDS
Pre-NDS Meeting
MPSNDS
Pre-SNDS Meeting
MPNC
Pre-NC Meeting
MPDIN
Pre-DIN Meeting
PRECTA
Pre-Clinical Trial Application Meeting
PRNDS
Priority Request NDS
PRSNDS
Priority Request SNDS
PAND
Pandemic Application
DMF Type I
Drug Master File Type I
DMF Type II
Drug Master File Type II
DMF Type III
Drug Master File Type III
DMF Type IV
Drug Master File Type IV
EU NDS
Extraordinary Use New Drug Submission
EU SNDS
Extraordinary Use Supplement to a New Drug Submission
UDRA
Undefined Regulatory Activity
UDRA
Undefined Regulatory Activity
DSUR
Development Safety Update Report
4.1.6 The <regulatory-activity-lead> Element

This mandatory element contains which group within Health Canada is expected to take the lead in reviewing the regulatory activity supported by this regulatory transaction.  This element cannot be repeated.  The content of this element is taken from a list of values defined by Health Canada and listed in the table below.

Table 3: Regulatory Activity Lead
Pharmaceutical
Includes all regulatory activities under the TPD mandate.
Biological
Includes all regulatory activities under the BGTD mandate.
Post-Market Pharmacovigilance
Includes all regulatory activities under the Marketed Health Products Directorate (MHPD) mandate.
Drug Master File
Includes all regulatory activities under the TPD - Bureau of Pharmaceutical Sciences (BPS), BGTD, Natural Health Products Directorate (NHPD), and Veterinary Drugs Directorate (VDD) mandates as defined in the Draft Guidance Document - Drug Master Files (DMFs)
4.1.7 The <sequence-number> Element

This mandatory element contains a four digit number which is the unique identifier for this sequence (regulatory transaction) inside the overall dossier.  This element cannot be repeated.  The schema ensures that the content is in the format "9999", i.e. four digits. Internally at Health Canada further validation will be performed to ensure that the number is unique within the dossier, and is greater than previously filed sequence.

The sequence number should have the same value as the corresponding folder name under the main folder, as described in the Electronic Common Technical Document Specification (Version 3.2.2).

4.1.8 The <sequence-description> Element

This mandatory element describes the sequence (regulatory transaction) based upon a series of possibilities outlined in Table 4 below.  This element cannot be repeated.  There are no schema-level constraints (i.e. content rules) on this element.  Note that many of the entries below include variable content such as dates, names, protocol numbers, etc.

Table 4: Sequence Description
Sequence Description Limited to this regulatory activity type only
Administrative NDS, ANDS, SNDS, SANDS, NC, DINA, DINB, EUNDS, EUSNDS
Cancellation Letter All types
Change to DIN DINA, DINB
Comments on Notice of Decision
dated mmm. dd, yyyy
NDS
Drug Notification Form NDS, SNDS, ANDS, SANDS, DINA, DINB, NC, EUNDS, EUSNDS
For Period of mmm. dd, yyyy to
mmm. dd, yyyy
PSUR-C, PSUR-PV, YBPR
INITIAL NDS, ANDS, DINA, DINB, EUNDS,
Minutes of Meeting, mmm. dd, yyyy All pre-submission meetings
Pandemic Application Upon consultation
Post-Authorization Division 1 Change PDC, PDC-B
Post Clearance Data NDS, SNDS, ANDS, SANDS, NC, EUNDS, EUSNDS, DINA, DINB
Post NOC Change SNDS, SANDS, EUSNDS, SNDS-C, NC
Year, list of change number
(for example: 2012, 15, 19a,….)
Level III Changes
Pre-Submission Meeting Package NDS, SNDS, NC, DINA, DINB
Priority Review Request NDS, SNDS
Pristine PM NDS, SNDS, ANDS, SANDS, SNDS-C, NC, EUNDS, EUSNDS, DINA, DINB
Pristine PM - Second Language NDS, SNDS, ANDS, SANDS, SNDS-C, NC, EUNDS, EUSNDS, DINA, DINB
Response to BE Clarification Request dated mmm. dd, yyyy NDS, SNDS, ANDS, SANDS,
Response to Clinical Clarification Request dated mmm. dd, yyyy NDS, SNDS, ANDS, SANDS, SNDS-C, EUNDS, EUSNDS, NC, DINA, DINB, PSUR-C
Response to e-mail Request dated
mmm. dd, yyyy
All types
Response to Labeling Clarification Request dated mmm. dd, yyyy NDS, SNDS, ANDS, SANDS, SNDS-C, NC, EUNDS, EUSNDS, DINA, DINB
Response to NOC/c-QN dated mmm.dd, yyyy NDS, SNDS, ANDS, SANDS, SNDS-C, EUNDS, EUSNDS
Response to NOL dated mmm. dd, yyyy NC
Response to NOD dated mmm. dd, yyyy NDS, SNDS, ANDS, SANDS, SNDS-C, EUNDS, EUSNDS
Response to NON dated mmm. dd, yyyy NDS, SNDS, ANDS, SANDS, SNDS-C, EUNDS, EUSNDS
Response to Processing Clarification Request dated mmm. dd, yyyy All types
Response to Quality and Clinical Clarification Request dated mmm. dd, yyyy NDS, SNDS, ANDS, SANDS, NC, EUNDS, EUSNDS, DINA, DINB
Response to Quality Clarification Request dated mmm. dd, yyyy NDS, SNDS, ANDS, SANDS, NC, EUNDS, EUSNDS, DINA, DINB
Response to Screening Acceptance Letter dated mmm. dd, yyyy NDS, SNDS, ANDS, SANDS, SNDS-C, NC, EUNDS, EUSNDS, DINA, DINB
Response to Screening Clarification Request dated mmm. dd, yyyy NDS, SNDS, ANDS, SANDS, SNDS-C, NC, EUNDS, EUSNDS, DINA, DINB
Response to SDN dated mmm. dd, yyyy NDS, SNDS, ANDS, SANDS, SNDS-C, EUNDS, EUSNDS
Response to Telephone Request dated
mmm. dd, yyyy
All types
Risk communication document UD-PV
Post Marketing Surveillance UD-PV
Benefit Risk Assessment UD-PV
Signal Work Up UD-PV
Response to MHPD Requests dated
mmm. dd, yyyy
UD-PV
Notification of Change in benefit-risk profile UD-PV
RMP version <number> dated mmm. dd, yyyy RMP-PV
Unsolicited Data, <Brief Description> NDS, SNDS, SANDS, SNDS-C, NC, EUNDS, EUSND, DINA, DINB, UDRA
Comments on Summary Basis of Decision dated mmm. dd, yyyy NDS, SNDS, EUNDS, EUSNDS, NC
Response to Advisement Letter dated
mmm. dd, yyyy
UDRA
DIN Discontinued UDRA
UFRI Generic Pilot ANDS, SANDS
Print on Demand All types
4.1.9 The <related-sequence-number> Element

This optional element contains the four digit sequence number of the first sequence in this regulatory activity. This element cannot be repeated (which is different from Module 1 v1). The schema ensures that the content is in the format "9999", i.e. four digits.

4.2 Preparing the electronic Common Technical Document (eCTD) Table of Contents (business content)

The <m1-administrative-and-product-information> element contains two broad categories of elements. Heading elements organize all of the electronic documents submitted as part of Module 1 into an electronic Table of Contents. They may be nested to make sub-headings. Leaf elements each describe one document along with other information such as check-sum and eCTD life-cycle information.

There are also special elements called node-extensions which can be used in places where leaf elements are allowed but act like heading elements for grouping documents.

No document (i.e. leaf element) is allowed inside a heading which contains sub-headings. To provide an analogy, leaves can only be at the end of the branches created by the heading elements. This is a change from the CA Module 1 v1.0.

4.2.1 Heading Elements

The top level headings are shown in Figure 3 below, inside the overall surrounding <m1-administrative-and-product-information> element. Note that they are all optional but must be in the order shown.

Please see "Summary of M1 Heading Elements" in Appendix B for a listing of all heading elements and their CTD equivalent terminology.

Figure 3: Example showing Element

Figure 3 is an example showing <m1-administrative-and-product-information>Element: The top level headings are shown in Figure 3, inside the overall surrounding <m1-administrative-and-product-information> element.  Note that they are all optional but must be in the order shown.
 
14 <m1-administrative-and-product information>
15 <m1-0-correspondence>
37 <m1-2-administrative information>
147 <m1-3-product-information>
206 <m1-4-health-canada-summaries> 
217 <m1-5-environmental-assessment-statement>
225 <m1-6-regional-clinical-information>
235 <m1-7-clinical-trial-information>
245 </m1-administrative-and-product-information>

4.2.1.1 The <m1-0-correspondence> Element

This optional element contains various sub-headings related to correspondence. This element cannot be repeated. The schema ensures that the content includes only the allowable sub-headings, as shown in Figure 4. There are no further sub-headings, i.e. each of the lowest headings below may contain leaf elements. Each of the sub-headings shown is also optional and cannot be repeated.

Figure 4: Example showing Element

Figure 4 is an example showing <m1-0-correspondence> Element: This optional element contains various sub-headings related to correspondence.  This element cannot be repeated.  The schema ensures that the content includes only the allowable sub-headings, as shown in Figure 4.  There are no further sub-headings, that is, each of the lowest headings below may contain leaf elements.  Each of the sub-headings shown is also optional and cannot be repeated. 

15 <m1-0-correspondence>
16 <m1-0-1-cover-letter>
21 <m1-0-2-life-cycle-management-table>
26 <m1-03-copy-of-health-canada-issued-correspondence>
28 <m1-04-health-canada-solicited-information>
30 <m1-0-5-meeting-information>
32 <m1-0-6-request-for-reconsideration-document>
34 <m1-0-7-general-note-to-reviewer>
36 </m1-0-correspondence>

4.2.1.2 The <m1-2-administrative-information> Element

This optional element contains various sub-headings related to administrative information. This element cannot be repeated. The schema ensures that the content includes only the allowable sub-headings, as shown in Figure 5. There are no further sub-headings, i.e. each of the lowest headings below may contain leaf elements. Each of the sub-headings shown is also optional and cannot be repeated.

Figure 5: Example showing Element

Figure 5 is an example showing <m1-2-administrative-information> Element: This optional element contains various sub-headings related to administrative information.  This element cannot be repeated.  The schema ensures that the content includes only the allowable sub-headings, as shown in Figure 5.  There are no further sub-headings, i.e. each of the lowest headings below may contain leaf elements.  Each of the sub-headings shown is also optional and cannot be repeated.

33 <m1-2-administrative-information>
34 <m1-2-1-application-forms>
42 <m1-2-2-fee-forms>
50 <m1-2-3-certification-and-attestation-forms>
70 <m-1-2-4-intellectual-property-information>
71 <m1-2-4-1-patent-information>
85 <m1-2-4-2-data-protection-information>
90 </m1-2-4-intellectual-property-information>
91 <m1-2-5-compliance-and-site-information>
92 <m1-2-5-1-clinical-trial-site-information-form
97 <m1-2-5-2-establishment-licensing>
102 <m1-2-5-3-good-clinical-practices>
107 </m1-2-5-4-good-laboratory-practices>
112 <m1-2-5-5-good-manufacturing practices>
117 <m1-2-5-6-good-pharmacovigilance-practices>
122 <m1-2-5-7-other-compliance-and-site-information-documents>
127 </m1-2-5-compliance-and-site-information>
128 <m1-2-6-authorization-for-sharing-information>
157 <m1-2-7-international-information>
177 <m1-2-8-post-authorization-information>
209 <m1-2-9-other-administrative-information>
214 </m1-2-administrative-information>

4.2.1.3 The <m1-3-product-information> Element

This optional element contains various sub-headings related to product information. This element cannot be repeated. The schema ensures that the content includes only the allowable sub-headings, as shown in Figure 6. There are no further sub-headings, i.e. each of the lowest headings below may contain leaf elements. Each of the sub-headings shown is also optional and cannot be repeated.

Figure 6: Example showing Element

Figure 6 is an example showing <m1-3-product-information> Element: This optional element contains various sub-headings related to product information. This element cannot be repeated.  The schema ensures that the content includes only the allowable sub-headings, as shown in Figure 6.  There are no further sub-headings, i.e. each of the lowest headings below may contain leaf elements.  Each of the sub-headings shown is also optional and cannot be repeated.

103 <m1-3-product-information>
104 <m1-3-1-product-monograph>
118 <m1-3-2-inner-and-outer-labels>
135 <m1-3-3-non-canadian-labelling>
149 <m1-3-4-investigators-brochure>
151 <m1-3-5-reference-product-labelling>
153 <m1-3-6-certified-product-information-document>
161 <m1-3-7-look-alike-sound-alike-assessment
166 <m1-3-8 pharmacovigilance-information>
167 <m1-3-8-1-pharmacovigilance-plan>
169 <m1-3-8-2-risk-management-plan>
174 <m1-3-8-3-risk-communications>
176 <m1-3-8-4-other-pharmacovigilance-information>
178 </m1-3-8-pharmacovigilance-information>
179 </m1-3-product-information>

4.2.1.4 The <m1-4-health-canada-summaries> Element

This optional element contains various sub-headings related to Health Canada Summaries. This element cannot be repeated. The schema ensures that the content includes only the allowable sub-headings, as shown in Figure 7. There are no further sub-headings, i.e. each of the lowest headings below may contain leaf elements. Each of the sub-headings shown is also optional and cannot be repeated.

Figure 7: Example showing Element

Figure 7 is an example showing <m1-4-health-canada-summaries> Element: This optional element contains various sub-headings related to Health Canada Summaries.  This element cannot be repeated.  The schema ensures that the content includes only the allowable sub-headings, as shown in Figure 7.  There are no further sub-headings, that is, each of the lowest headings below may contain leaf elements.  Each of the sub-headings shown is also optional and cannot be repeated.

206 <m1-4-health-canada-summaries>
207 <m1-4-1-pseat-cta>
209 <m1-4-2-comprehensive-summary-bioequivalence>
214 <m1-4-3-multidisciplinary-tabular-summaries>
216 </m1-4-health-canada-summaries>

4.2.1.5 The <m1-5-environmental-assessment-statement> Element

This optional element contains leaf elements (i.e. documents) related to environmental assessment, i.e. there are no sub-headings defined. This element cannot be repeated. The element is shown in Figure 8 with a leaf element.

Figure 8: Example showing Element

Figure 8 is an example showing <m1-5-environmental-assessment-statement> Element:

217 <m1-5-enviornmental-assessment-statement>
218 <leaf ID=”Nf6177b3edadd4f749fda468cfca93760” operation=”new” xlink:href=” 0001-ca-m15-env-assess-iv.pdf’ checksum=”51d79a5ec340f151f2719ba69a33ae30” checksum-type=”MD5”>
219 <title>001-ca-m15-env-assess-iv</title>
220 </leaf>
221 </m1-5-environmental-assessment-statement>

4.2.1.6 The <m1-6-regional-clinical-information> Element

This optional element contains various sub-headings related to regional clinical information. This element cannot be repeated. The schema ensures that the content includes only the allowable sub-headings, as shown in Figure 9. There are no further sub-headings, i.e. each of the lowest headings below may contain leaf elements. Each of the sub-headings shown is also optional and cannot be repeated.

Figure 9: Example showing Element

Figure 9 is an example showing <m1-6-regional-clinical-information> Element:

225 <m1-6-regional-clinical-information>
226 <m1-6-1-comparative-bioavailability-information>
228 <m1-6-2-company-core-data-sheets>
230 <m1-6-3-priority-review-requests>
232 <m1-6-4-notice-of-compliance-with-conditions>
234 </m1-6-regional-clinical-information>

4.2.1.7 The <m1-7-clinical-trial-information> Element

This optional element contains various sub-headings related to clinical trial information. This element cannot be repeated. The schema ensures that the content includes only the allowable sub-headings, as shown in Figure 10. There are no further sub-headings, i.e. each of the lowest headings below may contain leaf elements. Each of the sub-headings shown is also optional and cannot be repeated.

Figure 10: Example showing Element

Figure 10 is an example showing <m1-7-clinical-trial-information> Element:

235 <m1-7-clinical-trial-information>
236 <m1-7-1-study-protocol>
238 <m1-7-2-informed-consent-forms>
240 <m1-7-3-canadian-research-ethics-board-refusals>
242 <m1-7-4-information-on-prior-related-applications>
244 </m1-7-clinical-trial-information>

4.2.2 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 as defined by the ICH. Detailed information on leaf elements is provided in the Electronic Common Technical Document Specification (Version 3.2.2).

4.2.2.1 The <leaf> Element

This optional element contains one other element, the <title> element along with a number of attributes, all based upon the ICH eCTD definition provided in the Electronic Common Technical Document Specification (Version 3.2.2). This element can be repeated. The schema will additionally ensure the checksum-type attribute contains either "MD5" or "md5". An example is provided in Figure 11.

Figure 11: Example showing Element

Figure 11 is an example showing <leaf> Element:

28 <leaf ID=”ca0001m110100” operation=”new” xlink:href=”ca110100.pdf” checksum-type=”md5” checksum=”a11d3e5cd24fa823d45e665c4203c18b”>
29 <title>Cover letter</title>
30 </leaf>

4.2.2.2 The <node-extension> Element

In addition, wherever a <leaf> element is allowed in the schema, a <node-extension> element is also allowed. The <node-extension> structure allows the sponsor to effectively make arbitrary heading structures as desired. This advanced concept can be helpful in organizing multiple large collections of files which are all needing to be placed under a single normal eCTD heading.

The fact that the schema allows the node-extension structure is in compliance with general ICH guidelines, but should not be interpreted as a blanket permission to use the structures anywhere or without consideration. Sponsors may use these structures where needed to assist reviewers but may want to contact Health Canada for advice if the usage is novel.

The optional <node-extension> element contains a single mandatory <title> element, followed by at least one <leaf> element, and followed by another optional <node-extension> element. The element can be repeated.

A purely theoretical example is shown in Figure 12. The concept in the example is a simple Environmental Assessment Statement accompanied by two large Environmental Assessment Reports which have been organized using one and two-tier <node-extension> structures.

Figure 12: Example showing Elements

Figure 12 is an example showing <node-extension> Elements

157 <m1-2-7-international-information>
158 <node-extension>
159 <title>1.2.7.1 FDA</title>
160 <leaf ID="Ne89f9994af7b44ed91de3aece1292d6" operation="new"xlink:href="ca145023.pdf"  
checksum="3ed9f2abe2cff6e526407336d36ea9f9" checksum-type="MD5">
161 <title>Foreign refusals</title>
162 </leaf>
163 <leaf ID="Nf55a9df840384910a50844c53a8c3fde" operation="new" xlink:href="ca145024.pdf
checksum="f99c71d79a787ede7c4fbb1c9a3520" checksum-type="MD5">
164 <title>Foreign review reports</title>
165 </leaf>
166 <leaf ID="N0d410a1cb545dad9a45d54c309e48b4" operation="new" xlink:href="ca145025.pdf
                checksum="37f77evb07583ebec276b1594f973dea" checksum-type="MD5">
167 <title>Question and Answer (Q and A)documents</title>
168 </leaf>
169 </node extension>
170 <node-extension>
171 <title>1.2.7.2 EMA</title>
172 <leaf ID="N2828cc83f0b2493ca32a3b8ffdff2a60" operation="new" xlink:href="ca145026.pdf
                checksum="3ed9f2abe2cff6e526407336d36ea9f9" checksum-type="MD5">
173 <title> Foreign refusals</title>
174 </leaf>
175 <leaf ID="N489b9001fdb041858ee47c92dc6de6e2f7" operation="new" xlink:href="ca145027.pdf
                checksum="5c8c1f022fb19755afe04c4370bce592" checksum-type="MD5">
176 <title>Foreign review reports</title>
177 </leaf>
178 <leaf ID="Naece5d42ec784d24aaf84f431d057f6f" operation="new" xlink:href="ca145028.pdf
                checksum="5c8c1f022fb19755afe04c4370bce592" checksum-type="MD5">
179 <title>Question and Answer (Q and A)documents</title>
180 </leaf>
181 </node extension>
182 </m1-2-7-international-information>

5 Electronic Common Technical Document (Ectd) Preparation Tools

Health Canada does not mandate or recommend any particular software product for eCTD preparation.  However, based upon observing and assisting many sponsors with thousands of electronic regulatory activities Health Canada recommends that:

  • Prepare the eCTD using an authenticated commercial eCTD Preparation software.

    There are a wide variety of options available to sponsors for commercial eCTD preparation software, both in terms of multiple vendors and in terms of approaches [for example (e.g.) installed software, software as a service, service providers].  Sponsors are encouraged to find a solution which supports current and ongoing Health Canada eCTD requirements and meets their overall business needs.

  • Validate the prepared regulatory activity using an authenticated commercial eCTD Validation tool.

    Sponsors are encouraged to use a validation tool which supports checking current and ongoing Health Canada eCTD requirements.  These validation tools are not just XML "checkers" or "parsers", but actually evaluate the technical content of the regulatory activity.  There are numerous options available to sponsors, several of which are free.  This minimizes the possibility of technical validation errors with eCTD regulatory transactions sent to Health Canada which introduce delays into the overall regulatory process.

Appendices

Appendix A: References

Health Canada References:

The latest versions of these and other Health Canada guidance documents, policies, templates and forms can be obtained from the Health Canada website at:

  • http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/index-eng.php
  • http://www.hc-sc.gc.ca/dhp-mps/brgtherap/applic-demande/index-eng.php
  • Guidance for Industry: Preparation of Drug Regulatory Activities 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
International Conference on Harmonization (ICH) References

The ICH guidelines have been adopted by Health Canada and can be obtained from the ICH website at www.ich.org.

  • Electronic Common Technical Document Specification (Version 3.2.2)
  • eCTD IWG Question and Answer and Specification Change Request Document

Appendix B: Summary of Module 1 Heading Elements

The following table summarizes the heading elements found in the Canadian Module 1 Schema Version 2.2. Certain elements (e.g. "1.1 Table of Contents") have not been included in the eCTD as they are required only for paper regulatory activities, not for electronic regulatory activities in eCTD format.

Table 5: Summary of M1 Heading Elements
Section ID Business Terminology Related XML Element Occurrence Coding
1 Administrative and Product Information m1-administrative-and-product-information 1 .. 1
1.0 Correspondence m1-0-correspondence 0 .. 1
1.0.1 Cover letter m1-0-1-cover-letter 0 .. 1
1.0.2 Life Cycle Management Table m1-0-2-life-cycle-management-table 0 .. 1
1.0.3 Copy of Health Canada issued correspondence m1-0-3-copy-of-health-canada-issued-correspondence 0 .. 1
1.0.4 Health Canada Solicited Information m1-0-4-health-canada-solicited-information 0 .. 1
1.0.5 Meeting Information m1-0-5-meeting-information 0 .. 1
1.0.6 Request for Reconsideration Documentation m1-0-6-request-for-reconsideration-documentation 0 .. 1
1.0.7 General Note to Reviewer m1-0-7-general-note-to-reviewer 0 .. 1
1.2 Administrative Information m1-2-administrative-information 0 .. 1
1.2.1 Application Forms m1-2-1-application-forms 0 .. 1
1.2.2 Fee Forms m1-2-2-fee-forms 0 .. 1
1.2.3 Certification and Attestation Forms m1-2-3-certification-and-attestation-forms 0 .. 1
1.2.4 Intellectual Property Information m1-2-4-intellectual-property-information 0 .. 1
1.2.4.1 Patent Information m1-2-4-1-patent-information 0 .. 1
1.2.4.2 Data Protection Information m1-2-4-2-data-protection-information 0 .. 1
1.2.5 Compliance and Site Information m1-2-5-compliance-and-site-Information 0 .. 1
1.2.5.1 Clinical Trial Site Information Form m1-2-5-1-clinical-trial-site-information-form 0 .. 1
1.2.5.2 Establishment Licensing m1-2-5-2-establishment-licensing 0 .. 1
1.2.5.3 Good Clinical Practices m1-2-5-3-good-clinical-practices 0 .. 1
1.2.5.4 Good Laboratory Practices m1-2-5-4-good-laboratory-practices 0 .. 1
1.2.5.5 Good Manufacturing Practices m1-2-5-5-good-manufacturing-practices 0 .. 1
1.2.5.6 Good Pharmacovigilance Practices m1-2-5-6-good-pharmacovigilance-practices 0 .. 1
1.2.5.7 Other Compliance and Site Information m1-2-5-7-other-compliance-and-site-information 0 .. 1
1.2.6 Authorization for Sharing Information m1-2-6-authorization-for-sharing-information 0 .. 1
1.2.7 International Information m1-2-7-international-information 0 .. 1
1.2.8 Post- Authorization Information m1-2-8-post-authorization-information 0 .. 1
1.2.9 Other Administrative Information m1-2-9-other-administrative-information 0 .. 1
1.3 Product Information m1-3-product-information 0 .. 1
1.3.1 Product Monograph m1-3-1-product-monograph 0 .. 1
1.3.2 Inner and Outer Labels m1-3-2-inner-and-outer-labels 0 .. 1
1.3.3 Non-Canadian Labelling m1-3-3-non-canadian-labelling 0 .. 1
1.3.4 Investigator's Brochure m1-3-4-investigators-brochure 0 .. 1
1.3.5 Reference Product Labelling m1-3-5-reference-product-labelling 0 .. 1
1.3.6 Certified Product Information Document m1-3-6-certified-product-information-document 0 .. 1
1.3.7 Look-alike/Sound-alike Assessment m1-3-7-look-alike-sound-alike-assessment 0 .. 1
1.3.8 Pharmacovigilance Information m1-3-8-pharmacovigilance-information 0 .. 1
1.3.8.1 Pharmacovigilance Plan m1-3-8-1-pharmacovigilance-plan 0 .. 1
1.3.8.2 Risk Management Plan m1-3-8-2-risk-management-plan 0 .. 1
1.3.8.3 Risk Communications m1-3-8-3-risk-communications 0 .. 1
1.3.8.4 Other Pharmacovigilance Information m1-3-8-4-other-pharmacovigilance-information 0 .. 1
1.4 Health Canada Summaries m1-4-health-canada-summaries 0 .. 1
1.4.1 PSEAT-CTA m1-4-1-pseat-cta 0 .. 1
1.4.2 Comprehensive Summary : Bioequivalence m1-4-2-comprehensive-summary-bioequivalence 0 .. 1
1.4.3 Multidisciplinary Tabular Summaries m1-4-3-multidisciplinary-tabular-summaries 0 .. 1
1.5 Environmental Assessment Statement m1-5-environmental-assessment-statement 0 .. 1
1.6 Regional Clinical Information m1-6-regional-clinical-information 0 .. 1
1.6.1 Comparative Bioavailability Information m1-6-1-comparative-bioavailability-information 0 .. 1
1.6.2 Company Core Data Sheets m1-6-2-company-core-data-sheets 0 .. 1
1.6.3 Priority Review Requests m1-6-3-priority-review-requests 0 .. 1
1.6.4 Notice of Compliance with Conditions m1-6-4-notice-of-compliance-with-conditions 0 .. 1
1.7 Clinical Trial Information m1-7-clinical-trial-information 0 .. 1
1.7.1 Study Protocol m1-7-2-study-protocol 0 .. 1
1.7.2 Informed Consent Forms m1-7-3-informed-consent-forms 0 .. 1
1.7.3 Canadian Research Ethics Board (REB) Refusals m1-7-4-canadian-research-ethics-board-refusals 0 .. 1
1.7.4 Information on Prior-related Applications m1-7-5-information-on-prior-related-applications 0 .. 1

Appendix C: Definitions

Dossier - A collection of all regulatory activities throughout the life cycle of a product (e.g. human drug, veterinary drug, medical device, food).

Regulatory Activity - A collection of all regulatory transactions throughout the process of a specific activity which includes, but is not limited to, NDS, ANDS, DIN Application, YBPR, etc.

Regulatory Transaction - An information package sent by the sponsor as part of a regulatory activity such as Initial data, unsolicited and solicited data (e.g. response to a clarification request, NON, NOD, pristine PM, DNF etc.).

Undefined Regulatory Activity (UDRA) - A regulatory activity that has not been requested by Health Canada (unsolicited information) or other regulatory activities not listed in Table 2.

Undefined Data Pharmacovigilance (UDPV) - Post-market pharmacovigilance data such as: Risk communication document, Post Marketing Surveillance, Benefit Risk Assessment, Signal Work Up, Response to MHPD Requests for Additional Information, and Notification of Change in benefit-risk profile.

Response to Processing Clarification Request - A response to a request made during the processing stage by the Office of Submissions and Intellectual Property (OSIP).

Appendix d: Schema File

Primary file: ca-regional-v2-2.xsd

<?xml version="1.0" encoding="UTF-8"?>
<xs:schema xmlns:xs="http://www.w3.org/2001/XMLSchema" xmlns="hcsc_ectd" xmlns:xlink="http://www.w3.org/1999/xlink" targetNamespace="hcsc_ectd" elementFormDefault="qualified" attributeFormDefault="unqualified">
	<xs:import namespace="http://www.w3.org/1999/xlink" schemaLocation="xlink.xsd"/>
	<xs:import namespace="http://www.w3.org/XML/1998/namespace" schemaLocation="xml.xsd"/>
<!--
################################
 Health Canada root definition  
################################
-->
	<xs:element name="hcsc_ectd">
		<xs:complexType>
			<xs:sequence>
				<xs:element ref="ectd-regulatory-transaction-information"/>
				<xs:element ref="m1-administrative-and-product-information"/>
			</xs:sequence>
			<xs:attribute name="schema-version" use="required">
				<xs:simpleType>
					<xs:restriction base="xs:decimal">
						<xs:enumeration value="2.1"/>
					</xs:restriction>
				</xs:simpleType>
			</xs:attribute>
		</xs:complexType>
	</xs:element>
	<!--
################################
Health Canada specific data types 
################################
-->
	<!--
================================
Probable values to change begin here
================================
-->
	<xs:simpleType name="ca-dossier-type">
		<xs:restriction base="xs:string">
			<xs:enumeration value="Biologic Dossier"/>
			<xs:enumeration value="Pharmaceutical Dossier"/>
			<xs:enumeration value="Drug Master File Dossier"/>
		</xs:restriction>
	</xs:simpleType>
	<xs:simpleType name="ca-regulatory-activity-type">
		<xs:restriction base="xs:string">
			<xs:enumeration value="NDS"/>
			<xs:enumeration value="SNDS"/>
			<xs:enumeration value="SNDS-C"/>
			<xs:enumeration value="ANDS"/>
			<xs:enumeration value="SANDS"/>
			<xs:enumeration value="NC"/>
			<xs:enumeration value="CTA"/>
			<xs:enumeration value="CTA-A"/>
			<xs:enumeration value="DINA"/>
			<xs:enumeration value="DINB"/>
			<xs:enumeration value="PDC"/>
			<xs:enumeration value="PDC-B"/>
			<xs:enumeration value="PSUR-C"/>
			<xs:enumeration value="PSUR-PV"/>
			<xs:enumeration value="UD-PV"/>
			<xs:enumeration value="RMP-PV"/>
			<xs:enumeration value="Level III"/>
			<xs:enumeration value="YBPR"/>
			<xs:enumeration value="MPNDS"/>
			<xs:enumeration value="MPSNDS"/>
			<xs:enumeration value="MPNC"/>
			<xs:enumeration value="MPDIN"/>
			<xs:enumeration value="PRECTA"/>
			<xs:enumeration value="PRNDS"/>
			<xs:enumeration value="PRSNDS"/>
			<xs:enumeration value="PAND"/>
			<xs:enumeration value="DMF type I"/>
			<xs:enumeration value="DMF type II"/>
			<xs:enumeration value="DMF type III"/>
			<xs:enumeration value="DMF type IV"/>
			<xs:enumeration value="EU NDS"/>
			<xs:enumeration value="EU SNDS"/>
			<xs:enumeration value="UDRA"/>
			<xs:enumeration value="DSUR"/>
		</xs:restriction>
	</xs:simpleType>
	<xs:simpleType name="ca-regulatory-activity-lead">
		<xs:restriction base="xs:string">
			<xs:enumeration value="Pharmaceutical"/>
			<xs:enumeration value="Biological"/>
			<xs:enumeration value="Post-Market Pharmacovigilance"/>
			<xs:enumeration value="Drug Master File"/>
		</xs:restriction>
	</xs:simpleType>
	<!--
================================
Probable values to change end here
================================
-->
	<xs:simpleType name="ca-dossier-id">
		<xs:restriction base="xs:string">
			<xs:pattern value="[a-z][0-9]{6}"/>
		</xs:restriction>
	</xs:simpleType>
	<xs:simpleType name="ca-sequence-no">
		<xs:restriction base="xs:integer">
			<xs:pattern value="[0-9]{4}"/>
		</xs:restriction>
	</xs:simpleType>
	<xs:complexType name="ca-leaf-ext">
		<xs:sequence minOccurs="0" maxOccurs="unbounded">
			<xs:choice>
				<xs:element ref="leaf"/>
				<xs:element ref="node-extension"/>
			</xs:choice>
		</xs:sequence>
	</xs:complexType>
	<!--
################################
 ICH specific schema data types 
################################
-->
	<xs:simpleType name="ich-checksum-type">
		<xs:restriction base="xs:string">
			<xs:enumeration value="MD5"/>
			<xs:enumeration value="md5"/>
		</xs:restriction>
	</xs:simpleType>
	<xs:simpleType name="ich-leaf-operations">
		<xs:restriction base="xs:string">
			<xs:enumeration value="new"/>
			<xs:enumeration value="append"/>
			<xs:enumeration value="replace"/>
			<xs:enumeration value="delete"/>
		</xs:restriction>
	</xs:simpleType>
	<!--
================================
Leaf content per ICH                                              
================================
-->
	<xs:element name="leaf">
		<xs:complexType>
			<xs:sequence>
				<xs:element ref="title"/>
				<xs:element ref="link-text" minOccurs="0"/>
			</xs:sequence>
			<xs:attribute name="ID" type="xs:ID" use="required"/>
			<xs:attribute name="operation" type="ich-leaf-operations" use="required"/>
			<xs:attribute ref="xlink:href"/>
			<xs:attribute name="modified-file" type="xs:string"/>
			<xs:attribute name="checksum-type" type="ich-checksum-type"/>
			<xs:attribute name="checksum" type="xs:string"/>
			<xs:attribute name="application-version" type="xs:string"/>
			<xs:attribute name="version" type="xs:string"/>
			<xs:attribute name="keywords" type="xs:string"/>
			<xs:attribute name="font-library" type="xs:string"/>
			<xs:attribute ref="xlink:type"/>
			<xs:attribute ref="xlink:role"/>
			<xs:attribute ref="xlink:show"/>
			<xs:attribute ref="xlink:actuate"/>
			<xs:attribute ref="xml:lang"/>
		</xs:complexType>
	</xs:element>
	<xs:element name="node-extension">
		<xs:complexType>
			<xs:sequence>
				<xs:element ref="title"/>
				<xs:element ref="leaf" maxOccurs="unbounded"/>
				<xs:element ref="node-extension" minOccurs="0"/>
			</xs:sequence>
			<xs:attribute name="ID" type="xs:ID"/>
			<xs:attribute ref="xml:lang"/>
		</xs:complexType>
	</xs:element>
	<xs:element name="title">
		<xs:complexType>
			<xs:simpleContent>
				<xs:extension base="xs:string">
					<xs:attribute name="ID" type="xs:ID"/>
				</xs:extension>
			</xs:simpleContent>
		</xs:complexType>
	</xs:element>
	<xs:element name="link-text">
		<xs:complexType>
			<xs:sequence>
				<xs:element ref="xref" minOccurs="0"/>
			</xs:sequence>
			<xs:attribute name="ID" type="xs:ID"/>
		</xs:complexType>
	</xs:element>
	<xs:element name="xref">
		<xs:complexType>
			<xs:attribute name="ID" type="xs:ID" use="required"/>
			<xs:attribute ref="xlink:type"/>
			<xs:attribute ref="xlink:role"/>
			<xs:attribute ref="xlink:title"/>
			<xs:attribute ref="xlink:href"/>
			<xs:attribute ref="xlink:show"/>
		</xs:complexType>
	</xs:element>
	<!--
################################
Health Canada introductory content (meta data) structure
################################
-->
	<xs:element name="ectd-regulatory-transaction-information">
		<xs:complexType>
			<xs:sequence>
				<xs:element ref="applicant"/>
				<xs:element ref="product-name"/>
				<xs:element ref="dossier-identifier"/>
				<xs:element ref="dossier-type"/>
				<xs:element ref="regulatory-activity-type"/>
				<xs:element ref="regulatory-activity-lead"/>
				<xs:element ref="sequence-number"/>
				<xs:element ref="sequence-description"/>
				<xs:element ref="related-sequence-number" minOccurs="0"/>

			</xs:sequence>
		</xs:complexType>
	</xs:element>
	<xs:element name="applicant" type="xs:string"/>
	<xs:element name="product-name" type="xs:string"/>
	<xs:element name="dossier-identifier" type="ca-dossier-id"/>
	<xs:element name="dossier-type" type="ca-dossier-type"/>
	<xs:element name="regulatory-activity-type" type="ca-regulatory-activity-type"/>
	<xs:element name="regulatory-activity-lead" type="ca-regulatory-activity-lead"/>
	<xs:element name="sequence-number" type="ca-sequence-no"/>
	<xs:element name="sequence-description" type="xs:string"/>
	<xs:element name="related-sequence-number" type="ca-sequence-no"/>
	<!--
################################
Health Canada business content structure 
################################
-->
	<xs:element name="m1-administrative-and-product-information">
		<xs:complexType>
			<xs:sequence>
				<xs:element ref="m1-0-correspondence" minOccurs="0"/>
				<xs:element ref="m1-2-administrative-information" minOccurs="0"/>
				<xs:element ref="m1-3-product-information" minOccurs="0"/>
				<xs:element ref="m1-4-health-canada-summaries" minOccurs="0"/>
				<xs:element ref="m1-5-environmental-assessment-statement" minOccurs="0"/>
				<xs:element ref="m1-6-regional-clinical-information" minOccurs="0"/>
				<xs:element ref="m1-7-clinical-trial-information" minOccurs="0"/>
			</xs:sequence>
		</xs:complexType>
	</xs:element>
	<xs:element name="m1-0-correspondence">
		<xs:complexType>
			<xs:sequence>
				<xs:element ref="m1-0-1-cover-letter" minOccurs="0"/>
				<xs:element ref="m1-0-2-life-cycle-management-table" minOccurs="0"/>
				<xs:element ref="m1-0-3-copy-of-health-canada-issued-correspondence" minOccurs="0"/>
				<xs:element ref="m1-0-4-health-canada-solicited-information" minOccurs="0"/>
				<xs:element ref="m1-0-5-meeting-information" minOccurs="0"/>
				<xs:element ref="m1-0-6-request-for-reconsideration-documentation" minOccurs="0"/>
				<xs:element ref="m1-0-7-general-note-to-reviewer" minOccurs="0"/>
			</xs:sequence>
		</xs:complexType>
	</xs:element>
	<xs:element name="m1-0-1-cover-letter" type="ca-leaf-ext"/>
	<xs:element name="m1-0-2-life-cycle-management-table" type="ca-leaf-ext"/>
	<xs:element name="m1-0-3-copy-of-health-canada-issued-correspondence" type="ca-leaf-ext"/>
	<xs:element name="m1-0-4-health-canada-solicited-information" type="ca-leaf-ext"/>
	<xs:element name="m1-0-5-meeting-information" type="ca-leaf-ext"/>
	<xs:element name="m1-0-6-request-for-reconsideration-documentation" type="ca-leaf-ext"/>
	<xs:element name="m1-0-7-general-note-to-reviewer" type="ca-leaf-ext"/>
	<xs:element name="m1-2-administrative-information">
		<xs:complexType>
			<xs:sequence>
				<xs:element ref="m1-2-1-application-forms" minOccurs="0"/>
				<xs:element ref="m1-2-2-fee-forms" minOccurs="0"/>
				<xs:element ref="m1-2-3-certification-and-attestation-forms" minOccurs="0"/>
				<xs:element ref="m1-2-4-intellectual-property-information" minOccurs="0"/>
				<xs:element ref="m1-2-5-compliance-and-site-Information" minOccurs="0"/>
				<xs:element ref="m1-2-6-authorization-for-sharing-information" minOccurs="0"/>
				<xs:element ref="m1-2-7-international-information" minOccurs="0"/>
				<xs:element ref="m1-2-8-post-authorization-information" minOccurs="0"/>
				<xs:element ref="m1-2-9-other-administrative-information" minOccurs="0"/>
			</xs:sequence>
		</xs:complexType>
	</xs:element>
	<xs:element name="m1-2-1-application-forms" type="ca-leaf-ext"/>
	<xs:element name="m1-2-2-fee-forms" type="ca-leaf-ext"/>
	<xs:element name="m1-2-3-certification-and-attestation-forms" type="ca-leaf-ext"/>
	<xs:element name="m1-2-4-intellectual-property-information">
		<xs:complexType>
			<xs:sequence>
				<xs:element ref="m1-2-4-1-patent-information" minOccurs="0"/>
				<xs:element ref="m1-2-4-2-data-protection-information" minOccurs="0"/>
			</xs:sequence>
		</xs:complexType>
	</xs:element>
	<xs:element name="m1-2-4-1-patent-information" type="ca-leaf-ext"/>
	<xs:element name="m1-2-4-2-data-protection-information" type="ca-leaf-ext"/>
	<xs:element name="m1-2-5-compliance-and-site-Information">
		<xs:complexType>
			<xs:sequence>
				<xs:element ref="m1-2-5-1-clinical-trial-site-information-form" minOccurs="0"/>
				<xs:element ref="m1-2-5-2-establishment-licensing" minOccurs="0"/>
				<xs:element ref="m1-2-5-3-good-clinical-practices" minOccurs="0"/>
				<xs:element ref="m1-2-5-4-good-laboratory-practices" minOccurs="0"/>
				<xs:element ref="m1-2-5-5-good-manufacturing-practices" minOccurs="0"/>
				<xs:element ref="m1-2-5-6-good-pharmacovigilance-practices" minOccurs="0"/>
				<xs:element ref="m1-2-5-7-other-compliance-and-site-information-documents" minOccurs="0"/>
			</xs:sequence>
		</xs:complexType>
	</xs:element>
	<xs:element name="m1-2-5-1-clinical-trial-site-information-form" type="ca-leaf-ext"/>
	<xs:element name="m1-2-5-2-establishment-licensing" type="ca-leaf-ext"/>
	<xs:element name="m1-2-5-3-good-clinical-practices" type="ca-leaf-ext"/>
	<xs:element name="m1-2-5-4-good-laboratory-practices" type="ca-leaf-ext"/>
	<xs:element name="m1-2-5-5-good-manufacturing-practices" type="ca-leaf-ext"/>
	<xs:element name="m1-2-5-6-good-pharmacovigilance-practices" type="ca-leaf-ext"/>
	<xs:element name="m1-2-5-7-other-compliance-and-site-information-documents" type="ca-leaf-ext"/>
	<xs:element name="m1-2-6-authorization-for-sharing-information" type="ca-leaf-ext"/>
	<xs:element name="m1-2-7-international-information" type="ca-leaf-ext"/>
	<xs:element name="m1-2-8-post-authorization-information" type="ca-leaf-ext"/>
	<xs:element name="m1-2-9-other-administrative-information" type="ca-leaf-ext"/>
	<xs:element name="m1-3-product-information">
		<xs:complexType>
			<xs:sequence>
				<xs:element ref="m1-3-1-product-monograph" minOccurs="0"/>
				<xs:element ref="m1-3-2-inner-and-outer-labels" minOccurs="0"/>
				<xs:element ref="m1-3-3-non-canadian-labelling" minOccurs="0"/>
				<xs:element ref="m1-3-4-investigators-brochure" minOccurs="0"/>
				<xs:element ref="m1-3-5-reference-product-labelling" minOccurs="0"/>
				<xs:element ref="m1-3-6-certified-product-information-document" minOccurs="0"/>
				<xs:element ref="m1-3-7-look-alike-sound-alike-assessment" minOccurs="0"/>
				<xs:element ref="m1-3-8-pharmacovigilance-information" minOccurs="0"/>
			</xs:sequence>
		</xs:complexType>
	</xs:element>
	<xs:element name="m1-3-1-product-monograph" type="ca-leaf-ext"/>
	<xs:element name="m1-3-2-inner-and-outer-labels" type="ca-leaf-ext"/>
	<xs:element name="m1-3-3-non-canadian-labelling" type="ca-leaf-ext"/>
	<xs:element name="m1-3-4-investigators-brochure" type="ca-leaf-ext"/>
	<xs:element name="m1-3-5-reference-product-labelling" type="ca-leaf-ext"/>
	<xs:element name="m1-3-6-certified-product-information-document" type="ca-leaf-ext"/>
	<xs:element name="m1-3-7-look-alike-sound-alike-assessment" type="ca-leaf-ext"/>
	<xs:element name="m1-3-8-pharmacovigilance-information">
		<xs:complexType>
			<xs:sequence>
				<xs:element ref="m1-3-8-1-pharmacovigilance-plan" minOccurs="0"/>
				<xs:element ref="m1-3-8-2-risk-management-plan" minOccurs="0"/>
				<xs:element ref="m1-3-8-3-risk-communications" minOccurs="0"/>
				<xs:element ref="m1-3-8-4-other-pharmacovigilance-information" minOccurs="0"/>
			</xs:sequence>
		</xs:complexType>
	</xs:element>
	<xs:element name="m1-3-8-1-pharmacovigilance-plan" type="ca-leaf-ext"/>
	<xs:element name="m1-3-8-2-risk-management-plan" type="ca-leaf-ext"/>
	<xs:element name="m1-3-8-3-risk-communications" type="ca-leaf-ext"/>
	<xs:element name="m1-3-8-4-other-pharmacovigilance-information" type="ca-leaf-ext"/>
	<xs:element name="m1-4-health-canada-summaries">
		<xs:complexType>
			<xs:sequence>
				<xs:element ref="m1-4-1-pseat-cta" minOccurs="0"/>
				<xs:element ref="m1-4-2-comprehensive-summary-bioequivalence" minOccurs="0"/>
				<xs:element ref="m1-4-3-multidisciplinary-tabular-summaries" minOccurs="0"/>
			</xs:sequence>
		</xs:complexType>
	</xs:element>
	<xs:element name="m1-4-1-pseat-cta" type="ca-leaf-ext"/>
	<xs:element name="m1-4-2-comprehensive-summary-bioequivalence" type="ca-leaf-ext"/>
	<xs:element name="m1-4-3-multidisciplinary-tabular-summaries" type="ca-leaf-ext"/>
	<xs:element name="m1-5-environmental-assessment-statement" type="ca-leaf-ext"/>
	<xs:element name="m1-6-regional-clinical-information">
		<xs:complexType>
			<xs:sequence>
				<xs:element ref="m1-6-1-comparative-bioavailability-information" minOccurs="0"/>
				<xs:element ref="m1-6-2-company-core-data-sheets" minOccurs="0"/>
				<xs:element ref="m1-6-3-priority-review-requests" minOccurs="0"/>
				<xs:element ref="m1-6-4-notice-of-compliance-with-conditions" minOccurs="0"/>
			</xs:sequence>
		</xs:complexType>
	</xs:element>
	<xs:element name="m1-6-1-comparative-bioavailability-information" type="ca-leaf-ext"/>
	<xs:element name="m1-6-2-company-core-data-sheets" type="ca-leaf-ext"/>
	<xs:element name="m1-6-3-priority-review-requests" type="ca-leaf-ext"/>
	<xs:element name="m1-6-4-notice-of-compliance-with-conditions" type="ca-leaf-ext"/>
	<xs:element name="m1-7-clinical-trial-information">
		<xs:complexType>
			<xs:sequence>
				<xs:element ref="m1-7-1-study-protocol" minOccurs="0"/>
				<xs:element ref="m1-7-2-informed-consent-forms" minOccurs="0"/>
				<xs:element ref="m1-7-3-canadian-research-ethics-board-refusals" minOccurs="0"/>
				<xs:element ref="m1-7-4-information-on-prior-related-applications" minOccurs="0"/>
			</xs:sequence>
		</xs:complexType>
	</xs:element>
	<xs:element name="m1-7-1-study-protocol" type="ca-leaf-ext"/>
	<xs:element name="m1-7-2-informed-consent-forms" type="ca-leaf-ext"/>
	<xs:element name="m1-7-3-canadian-research-ethics-board-refusals" type="ca-leaf-ext"/>
	<xs:element name="m1-7-4-information-on-prior-related-applications" type="ca-leaf-ext"/>
</xs:schema>
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