Submission Maintenance

Use Submission Maintenance to specify values for eCTD Modules. Use the Submission Maintenance pages to define:

— Values for supporting the US eCTD Module 1 v2.3 specification (DTD 3.3). You can select these values for extended attributes of an assembly. In the Create eCTD wizard, you can do this after selecting the necessary template.

— Values for supporting the CN eCTD Module 1 v1.0 specification. You can select these values for extended attributes of an assembly. In the eCTD wizard, you can do this after selecting the necessary template.

Attribute Description
Version Number The version number of the term in the RMS list from the RMS details.
ISO Code The ISO Code for the term in the RMS list from the RMS details.

— Values for supporting the ZA eCTD Module 1 v3.1 specification. You can select these values for extended attributes of an assembly. In the eCTD wizard, you can do this after selecting the necessary template. — Fonts that you can use in tab sheets created in Ennov InSight .

Note: Viewing and modifying Submission Maintenance values requires specific Data Administration access privileges.

When you click a type of value under Submission Maintenance, a page shows a table of all defined values for that type. You can sort these values by column. The default view is sorted in ascending, alphanumeric order.

On the Submission Maintenance pages, you can set the status of a value to Active or Inactive.

Submission Maintenance: Submission Values

The following submission values can be created and maintained under Submission Maintenance:

Value Description
Applicant Contact Type The applicant contact types that match the codes that the regulatory agency provides.
Applicant Contact All active applicant contact values.
Applicant ID The applicant ID.
Application Form Type The application form types that match the codes that the regulatory agency provides.
Drug Registration File Documents Section The values that EAEU defines to describe a drug registration file documents section.

Drug Registration File

Documents

 The values that EAEU defines to describe a drug registration file documents.
Value Description
Evaluation Pathway The Evaluation Pathway applicable to the ZA submissions.
Font Definition The fonts that you can use in tab sheets created in Ennov InSight Publisher. For further information, refer to the Font Definition Attribute table below.
Leaf Status

The status that can be assigned to a leaf. When assigned, helps to identify the leafs in an assembly that need to be published or have already been published. Three "out-of-the-box" statuses are provided:

— Planned

— Ready for Publish — Published

Default value is Planned. For further information, refer to the Leaf Status Attributes table below.
PDF Properties The PDF properties that you can use in Leaf Elements and Publishing Settings Library. For further information, refer to the PDF Properties Attributes table below.
Promotional Material Audience Type The promotional material audience types that match the code that the regulatory agency provides.
Promotional Material Doc Type The promotional material doc types that match the codes that the regulatory agency provides.
Promotional Material Type The promotional material types that match the codes that the regulatory agency provides.
Regulatory Activity Lead Health Canada groups that can take the lead in reviewing the regulatory activity that a regulatory transaction supports.
Sequence Description The values that Health Canada defines to describe a sequence (regulatory transaction).
Submission Product Type The values that describe a submission product type as defined by the China region.
Sub Filing Type The sub filing types that match the codes that the regulatory agency provides.
Supplement Effective Date Type The supplement effective date types that match the codes that the regulatory agency provides.
Telephone Number Type The telephone number types that match the codes that the regulatory agency provides.

Applicant Contact Type Attributes To define an applicant contact type, enter values for the following attributes:

Attribute Description
eCTD Standard Type Can be either eCTD 3.2 or eCTD 4.0 defining the version where the value is applicable. By default, the eCTD 3.2 is displayed. It is always eCTD 4.0 if associated from eCTD 4.0 controlled vocabulary. See Associate eCTD 4.0 Applicant Contact Type and eCTD 4.0 Applicant Contact Type Attributes.
Region All active values of Regulatory Region type from the Region Values are available for selection.
Regulatory Code Regulatory Code provided by the Regulatory Agency.
Applicant Contact Type Applicant Contact Type name matching the code provided by the agency.
Last User Updated Indicates the name of the user who last created/updated the applicant contact type. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active Indicates if the entity is active or inactive.

Applicant Contact Attributes To define an applicant contact, enter values for the following attributes:

Attribute Description
Region All active values of Regulatory Region type from the Region Values are available for selection.
Applicant Contact Name Name of the applicant contact.
Applicant Contact Type All active values from the Applicant Contact Type Values.
UUID Universal Unique Identifier of the applicant contact.
Prefix A title placed before the applicant contact name. Example: Mr.(Mister), Mrs. (Missis), Dr. (Doctor), Prof. (Professor).
First Name First name of the applicant contact.
Middle Name Middle name of the applicant contact.
Last Name Last name of the applicant contact.
Suffix A title placed after the applicant contact name. Example: Jr.(Junior), Sr. (Senior), Ph.D (Doctor of Philosophy).
Initials Capitalized letters representing each word of in an applicant contact name. Example: M.J.S (Mary Jane Smith).
Delimiter Character used to separate different parts of texts.
Attribute Description

Represented Company

Name

 Name of the company or organization.
Last User Updated Indicates the name of the user who last created/updated the applicant contact. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active Indicates if the entity is active or inactive.

Applicant ID Attributes

To define an applicant ID, enter values for the following attributes:

Attribute Description
Region All active values of Regulatory Region type from the Region Values are available for selection.
Applicant ID Format The format for the Applicant ID. Allowed values: DUNS.
Applicant Name Applicant Name matching the Applicant ID.
Applicant ID Applicant ID must be unique within the region.
Default for Region Yes and No values are available for selection to indicate if the region is the default or not.
Note: Only one region can have the default flag set to Yes within the system. When you change the region to the default, the previously defaulted entity is automatically updated to have the default flag set to No.
Last User Updated Indicates the name of the user who last created/updated the applicant ID values. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active Indicates if the entity is active or inactive.

Application Form Type Attributes

To define an application form type, enter values for the following attributes:

Attribute Description
Region All active values of Regulatory Region type from the Region Values are available for selection.
Regulatory Code Regulatory Code provided by the Regulatory Agency.
Application Form Type Application Form Type name matching the code provided by the agency.
Last User Updated Indicates the name of the user who last created/updated the application form type. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active Indicates if the entity is active or inactive.

Drug Registration File Documents Section Attributes

To define a drug registration file documents section, enter values for the following attributes:

Attribute Description
Section Code Section code provided by agency.
Name Name provided by agency.
Last User Updated Indicates the name of the user who last created/updated the drug registration file documents section. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active Indicates if the entity is active or inactive.

Drug Registration File Document Attributes

To define a drug registration file document, enter values for the following attributes:

Attribute Description
Section Section code provided by agency. All active values of Section Code from the Drug Registration File Documents Section Values are available for selection.
Document Code Document code provided by agency.
Name Name provided by agency.
Attribute Description
Last User Updated Indicates the name of the user who last created/updated the drug registration file document. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active Indicates if the entity is active or inactive.

Evaluation Pathway Attributes

To define an evaluation pathway, enter values for the following attributes:

Attribute Description
Region All active values of Regulatory Region type from the Region Values are available for selection.
Applicable DTD/Schema All active DTD/Schemas from the Assembly DTD/Schema Types limited by the selected Region.
eCTD Code The regulatory code from the controlled vocabulary provided by the agency.
Evaluation Pathway The Evaluation Pathway applicable to the submission.
Last User Updated Indicates the name of the user who last created/updated the evaluation pathway. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active Indicates if the entity is active or inactive.

Font Definition Attributes

To define a font, enter values for the following attributes:

Attribute Description
Font Display Name The font name that appears on the Tab Sheet Attributes page.
Font Name Must match the font name on the Ennov InSight Rendering server.
Font Code Used when an assembly with tab settings is exported from or imported into Ennov InSight .
Attribute Description
Last User Updated Indicates the name of the user who last created/updated the font definition. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active Indicates if the entity is active or inactive.

Leaf Status Attributes

To define a leaf status, enter values for the following attributes:

Attribute Description
Leaf Status Name The leaf status name that appears in Leaf Elements. The name must be unique within the system.
Default Flag Yes and No values are available for selection to indicate if the leaf status is the default or not.
Note: Only one leaf status can have the default flag set to Yes within the system. When you change leaf status to the default, the previously defaulted entity is automatically updated to have the default flag set to No.
Internal System Status

The internal system status to associate to the leaf status. The values available for selection are PLANNED, NOT APPROVED, and PUBLISHED.

Or, you can leave the field blank.
Last User Updated Indicates the name of the user who last created/updated the leaf status. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active Indicates if the entity is active or inactive.

PDF Properties Attributes

To define a PDF property, enter values for the following attributes:

Attribute Description
PDF Property Name The PDF property name that appears in Leaf Elements and Publishing Settings Library.
Attribute Description
Source Property Yes and No values are available for selection to indicate if the property is a source or not.
Target Property Yes and No values are available for selection to indicate if the property is a target or not.
Last User Updated Indicates the name of the user who last created/updated the PDF properties. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active Indicates if the entity is active or inactive.

Promotional Material Audience Type Attributes

To define a promotional material audience type, enter values for the following attributes:

Attribute Description
Region All active values of Regulatory Region type from the Region Values are available for selection.
Regulatory Code Regulatory Code provided by agency.
Promotional Material Audience Type Promotional Material Audience Type name matching the code provided by the agency.
Last User Updated Indicates the name of the user who last created/updated the promotional material audience type. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active Indicates if the entity is active or inactive.

Promotional Material Doc Type Attributes

To define a promotional material doc type, enter values for the following attributes:

Attribute Description
Region All active values of Regulatory Region type from the Region Values are available for selection.
Regulatory Code Regulatory Code provided by agency.
Attribute Description
Promotional Material Doc Type Promotional Material Doc Type name matching the code provided by the agency.
Last User Updated Indicates the name of the user who last created/updated the promotional material doc type. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active Indicates if the entity is active or inactive.

Promotional Material Type Attributes

To define a promotional material type, enter values for the following attributes:

Attribute Description
Region All active values of Regulatory Region type from the Region Values are available for selection.
Regulatory Code Regulatory Code provided by agency.
Promotional Material Type Promotional Material Type matching the code provided by the agency.
Last User Updated

Indicates the name of the user who last created/updated the promotional

material type. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active Indicates if the entity is active or inactive.

Regulatory Activity Lead Attributes

To define a regulatory activity lead, enter values for the following attributes:

Attribute Description
Region All active values of Regulatory Region type from the Region Values are available for selection.
eCTD Code The regulatory code from the controlled vocabulary provided by the agency.
Regulatory Activity Lead The regulatory activity lead which corresponds to the eCTD code.
Attribute Description
Applicable DTD/Schema All active DTD/Schemas from the Assembly DTD/Schema Types limited by the selected Region.
Last User Updated

Indicates the name of the user who last created/updated the regulatory

activity lead. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active Indicates if the entity is active or inactive.

Submission Product Type Attributes

To define a submission product type, enter values for the following attributes:

Attribute Description
Region Region value for Submission Product Type. All active values of Regulatory Region type from the Region Values are available for selection.
eCTD Code eCTD Code provided by agency.
Product Type Description of Product Type. Allowed values:Chemical Product or Biological Product .
Applicable DTD/Schema List of DTD names filtered out by selected region.
Last User Updated

Indicates the name of the user who last created/updated the submission

product type. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active Indicates if the entity is active or inactive.

Sequence Description Attributes

To define a sequence description, enter values for the following attributes:

Attribute Description
Region All active values of Regulatory Region type from the Region Values are available for selection.
eCTD Code The regulatory code from the controlled vocabulary provided by the agency. Combination of DTD/Schema and eCTD Code must be unique.
Sequence Description The submission description which corresponds to the regulatory code.
Attribute Description
Sequence Description Additional Data Type The type of additional data (variables) that can be used in the description. Values available for selection are: Text, Date Range, Date, Number and Date.
Applicable DTD/Schema All active DTD/Schemas from the Assembly DTD/Schema Types limited by the selected Region.
Last User Updated

Indicates the name of the user who last created/updated the sequence

description. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active Indicates if the entity is active or inactive.

Sub Filing Type Attributes

To define a sub filing type, enter values for the following attributes:

Attribute Description
Sub Filing Type Sub Filing Type matching the code provided by the agency. Sub Filing Type must be unique.
Countries Countries that are applicable to this sub type.
Last User Updated Indicates the name of the user who last created/updated the sub filing type. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active Indicates if the entity is active or inactive.

Supplement Effective Date Type Attributes

To define a supplement effective date type, enter values for the following attributes:

Attribute Description
Supplement Effective Date Type Name Supplement Date Effective Type name matching the code provided by the agency.
Countries A list of all countries that this effective date type applies to.
Attribute Description
Last User Updated Indicates the name of the user who last created/updated the supplement effective date type. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active Indicates if the entity is active or inactive.

Telephone Number Type Attributes

To define a telephone number type, enter values for the following attributes:

Attribute Description
Region All active values of Regulatory Region type from the Region Values are available for selection.
Regulatory Code Regulatory Code provided by the Regulatory Agency.
Telephone Number Type Telephone Number Type name matching the code provided by the agency.
Last User Updated

Indicates the name of the user who last created/updated the telephone

number type. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active Indicates if the entity is active or inactive.

Associate eCTD 4.0 Applicant Contact Type

Associate applicant contact type to conform to the eCTD 4.0 submission requirements.

To associate eCTD 4.0 applicant contact type:

  1. On the homepage, click Go To > Data Administration > Submission Maintenance.
  2. Click Applicant Contact Type Values.
  3. Click the Associate eCTD 4.0 Applicant Contact Type .

    The list of all active values from Submission Contact Type CV is displayed, excluding those already added.

  4. Filter the values with by Region, CV OID, Code or Value.
  5. Select the required information from the list.
  6. Click Associate .

Update Applicant Contact Type Values

Make changes to existing applicant contact type values to include appropriate information in submission.

To update applicant contact type values:

  1. On the homepage, click Go To > Data Administration > Submission Maintenance.
  2. Click Applicant Contact Type Values.
  3. Click Regulatory Code for the selected applicant contact type.
  4. Modify the attributes.
  5. Click Save.

eCTD 4.0 Applicant Contact Type Attributes

Use the following attributes to filter eCTD 4.0 applicant contact type values.

Attribute Description
Region The region name taken from Data Administration > Region Values.
CV OID Object identifier of the controlled vocabulary profile provided by CV service.
Code Regulatory code provided by the regulatory agency.
Value The contact type of the controlled vocabulary profile provided by CV service.