Ennov InSight RIM Publisher 7.1

Extension Type: Regional Folders

Eurasian Economic Union

Extension Type Associated Attributes Applied to Assembly Element Result
EAEU Module 1 Envelope Information
  • EDoc Id
  • EDoc Reference Id
  • EDoc Date Time
  • Country
  • Registration Number Id
  • Application Id
  • Registration Kind Code
  • Submission Sequence
EAEU Module 1 Envelope Information folder in EAEU Template v1.0 assembly template Attribute values provided for each folder with this type complete the envelope information within the index-r-022.xml file.
Quality Overall Summary No additional attributes Quality Overall Summary folder in EAEU Template v1.0 assembly template. Creates the appropriate <m2-3-quality-overall-summary> element in the index-r-022.xml file.
Drug Substance
  • Drug Product Name
  • Drug Substance Manufacturer
Drug Substance folder in EAEU Template v1.0 assembly template. Creates the appropriate <drug_substance> element in the index-r-022.xml file.
Solvent
  • Solvent Name
  • Solvent Manufacturer
Solvent folder in EAEU Template v1.0 assembly template. Attribute values provided for each folder of this type contain information about every solvent set within index-r-022.xml file and included under each leaf entry as additional attributes.

European Union

Extension Type Associated Attributes Applied to Assembly Element Result
EU Module 1 folder No additional attributes 1 Administrative Information and Prescribing Information folder in EU Module 1 assembly template When applied to an Assembly folder that is using the eu-2-0 XML Definition file, triggers the creation of the eu-regional.xml file during publishing. The child folders of this folder complete the content included in the eu-regional.xml file.
EU Module 1 Envelope Information folder (v3.1)
  • Country
  • UUID
  • Submission Type
  • Submission Mode
  • High-Level/ Worksharing Submission Number
  • Application Tracking Number
  • Submission Unit Type
  • Applicant
  • Agency Name
  • Procedure Type
  • Invented Name
  • INN
  • Sequence
  • Related Sequence
  • Submission Description
Depending on the procedure type/template selected, there will be appropriate CC Envelope Information folder(s) that is a child of the EU Envelope Information leaf in EU Module 1 assembly template. A folder for each country applicable in the sequence should be included to provide the appropriate envelope information. Attribute values provided for each folder with this type complete the envelope information for the country specified within the eu-regional.xml file. You must create a separate folder for each country for which envelope information is provided. These folders should reside beneath the EU Envelope Information Leaf to ensure proper behavior during life cycle updates. Multiple comma-separated values can be provided for:
  • Application Tracking number
  • Invented Name
  • INN
  • Related Sequence
EU Module 1 Envelope Information folder (v3.0, v3.0.1)
  • Country
  • UUID
  • Submission Type
  • Submission Mode
  • High-Level/ Worksharing Submission Number
  • Application Tracking Number
  • Submission Unit Type
  • Applicant
  • Agency Name
  • Procedure Type
  • Invented Name
  • INN
  • Sequence
  • Related Sequence
  • Submission Description
Depending on the procedure type/template selected, there will be appropriate CC Envelope Information folder(s) that is a child of the EU Envelope Information leaf in EU Module 1 assembly template. A folder for each country applicable in the sequence should be included to provide the appropriate envelope information.
Attribute values provided for each folder with this type complete the envelope information for the country specified within the eu-regional.xml file. You must create a separate folder for each country for which envelope information is provided. These folders should reside beneath the EU Envelope Information Leaf to ensure proper behavior during life cycle updates. Multiple comma-separated values can be provided for:
  • Application Tracking number
  • Invented Name
  • INN
  • Related Sequence
EU Module 1 Envelope Information folder (v2.0)
  • Country
  • Submission Type
  • Submission Mode
  • High-Level/ Worksharing Submission Number
  • Application Tracking Number
  • Applicant
  • Agency Name
  • Procedure Type
  • Invented Name
  • INN
  • Sequence
  • Related Sequence
  • Submission Description
Depending on the procedure type/template selected, there will be appropriate CC Envelope Information folder(s) that is a child of the EU Envelope Information leaf in EU Module 1 assembly template. A folder for each country applicable in the sequence should be included to provide the appropriate envelope information. Attribute values provided for each folder with this type complete the envelope information for the country specified within the eu-regional.xml file. You must create a separate folder for each country for which envelope information is provided. These folders should reside beneath the EU Envelope Information Leaf to ensure proper behavior during life cycle updates. Multiple comma-separated values can be provided for:
  • Application Tracking number
  • Invented Name
  • INN
  • Related Sequence
EU Module 1 Country-specific Information folder
  • Country
  • Language
  • In EU Module 1 Assembly template, applied to the following folders:
  • 1.0 Cover Letter
  • 1.2 Application Forms
  • 1.3.2 Mock-up
  • 1.3.3 Specimen
  • 1.3.4 Readability Testing
  • 1.3.5 SPCs already approved in Member States
Creates the appropriate <m1-0-cover>, <m1-2-form>, <m1-3-2-mockup>, <m1-3-4-readability>, and <m1-3-5-approved> elements in eu-regional.xml with country values for the <specific> child element. Also includes the appropriate country values in the output directory structure. Each folder with this type can be duplicated for different countries and/or languages for which information is being provided.
EU Module 1 Labeling Information folder
  • Country
  • Language
  • Labeling type
  • 1.3.1 SPC, Labeling and Package Leaflet folder in EU Module 1 Assembly template
Creates the appropriate <m1-3-1--spc-label-pl> element with the <pi-doc> child element using attribute values to populate the attributes of the <pi-doc> element. Also includes appropriate country and language information in the output directory structure. Each folder with this type can be duplicated for different countries, languages, and/or labeling types for which information is being provided. The Create eCTD Wizard allows the user to indicate which sections should be included for all countries.
EU Responses folder
  • Country
  • Language
Responses to Questions folder in the EU Module 1 Assembly template Creates the appropriate <m1-responses> element in eu-regional.xml with country values for the <specific> child element. Also includes appropriate country information values in the output directory structure. 
EU Additional Information folder
  • Country
  • Language
Additional Data folder in the EU Module 1 Assembly template Creates the appropriate <m1-additional> element in eu-regional.xml with country values for the <specific> child element. Also includes appropriate country information values in the output directory structure.

Canada

Extension Type Associated Attributes Applied to Assembly Element Result
Canadian Module 1 folder (v2.2)
  • Applicant
  • Product Name
  • Dossier Identifier
  • Dossier Type
  • Regulatory Activity Type
  • Regulatory Activity Lead
  • Sequence Number
  • Submission Description
  • Related Sequence Number
1 Administrative and Product Information folder in Canadian Module 1 assembly template When applied to a folder in an Assembly that is using the ca-2-2 XML Definition file, triggers the creation of the ca-regional.xml file during publishing. The values of the attributes populated on this folder are used to complete the values of the elements and attributes in the <ectd-regulatory-transaction-information> element of the ca-regional.xml file. The child folders of this folder complete the remainder of the ca-regional.xml file.

China

Extension Type Associated Attributes Applied to Assembly Element Result
CN Module 1 v1.0 folder
  • Application Number
  • Application Type
  • Product Type
  • Original Number
  • Related Sequence
  • Regulatory Activity Type
  • Sequence Number
  • Sequence Type
  • Sequence Description
  • Sequence Contact Name
  • Sequence Contact Telephone
  • Sequence Contact Email
CN Module 1 Administration Information folder in CN Module 1 assembly template When applied to an Assembly folder that is using the cn-1-0 XML Definition file, triggers the creation of the cn-regional.xml file during publishing. The child folders of this folder complete the content included in the cn-regional.xml file.

United States

Extension Type Associated Attributes Applied to Assembly Element Result
US Module 1 folder (v2.01)
  • Company Name
  • Submission Date
  • Application Number
  • Product name and type
  • Application Type
  • Submission Type
  • Sequence Number
  • Related Sequence Number
1 Administrative Information and Prescribing Information folder in US Module 1 assembly template (v2.01) When applied to folder in an Assembly that is using the us-2-0-1 XML Definition file, triggers the creation of the us-regional.xml file during publishing. The values of the attributes populated on this folder are used to complete the values of the elements and attributes in the <admin> element of the us-regional.xml file. Multiple related sequence number values may be added by separating them with commas. The child folder and leaf elements in this folder complete the remainder of the us-regional.xml file.
US Module 1 folder (DTD v3.3)
  • Applicant ID
  • Company Name
  • Submission Description
  • Applicant Contact
  • Application Number
  • Application Contains Files?
  • Application Type
  • Cross-Reference Application 
  • Sequence Number
  • Submission ID
  • Submission Type
  • Submission Sub-Type
  • Supplement Effective Date Type
1 Administrative Information folder in US Module 1 assembly template (v3.3) When applied to a folder in an Assembly that is using the us-3-3 XML Definition file, triggers the creation of the us-regional.xml file during publishing. The values of the attributes populated on this folder are used to complete the values of the elements and attributes in the <admin> element of the us-regional.xml file. The child folders of this folder complete the remainder of the us-regional.xml file.
US Admin Forms folder Application Form Type The following folders in US Module 1 assembly template (v3.3):
  • 1.1.1 Form FDA 1571: Investigational New Drug Application (IND)
  • 1.1.2 Form FDA 356h: Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use folders in
Creates the appropriate <form form-type=""> element within the <submission-information> element in us-regional.xml.
US Forms folder Application Form Type The following folders in US Module 1 assembly template (v3.3):
  • 1.1.3 Form FDA 3397: User Fee Cover Sheet
  • 1.1.4 Form FDA 2252: Transmittal of Annual Reports for Drugs and Biologics for Human Use
  • 1.1.5 Form FDA 2253: Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use
  • 1.1.6 Form FDA 2567: Transmittal of Labels and Circulars
  • 1.1.7 Form FDA 3674: Certification of Compliance
  • 1.1.8 Form FDA 3792: Biosimilar User Fee Cover Sheet (BsUFA)
  • 1.1.9 Form FDA 3794: Generic Drug User Fee Cover Sheet (GDUFA)
Creates the appropriate <form form-type=""> element within the  <m1-1-forms> element in us-regional.xml.
Promotional Material Audience Type folder Promotional Material Audience Type 1.15 Promotional Material Audience Type folder in US Module 1 assembly template (v3.3) Creates the appropriate <m1-15-promotional-material> element in us-regional.xml. The value of the attribute populated on this folder is used to complete the promotional-material-audience-type attribute of <m1-15-promotional-material> element.
Promotional Material Doc Type folder Promotional Material Doc Type 1.15.2 Materials folder in US Module 1 assembly template (v3.3) Creates the appropriate <m1-15-2-materials> element in us-regional.xml. The value of the attribute populated on this folder is used to complete the promotional-material-doc-type attribute of <m1-15-2-materials> element.
Promotional Material Type folder
  • Promotional Material Type
  • Promotional Material ID
  • Issue Date
1.15.2.1 Material folder in US Module 1 assembly template (v3.3) Creates the appropriate <m1-15-2-1-material> element in us-regional.xml. The values of the attributes populated on this folder are used to complete the attributes <m1-15-2-1-material> element.

Japan

Extension Type Associated Attributes Applied to Assembly Element Result
JP Module 1 folder
  • Submission Number
  • Brand Name
  • Sequence Number
  • Generic Name
  • Applicant
  • Submission Date
  • Submission Type
  • Operation
1 Administrative Information and Prescribing Information folder in JP Module 1 assembly template When applied to a folder in an Assembly that is using the jp-1-0 XML Definition file, triggers the creation of the jp-regional-index.xml file during publishing. The values of the attributes populated on this folder are used to complete the values of the elements and attributes in the <content-block param="admin"> element of the jp-regional-index.xml file.

Multiple values for fields Brand Name, Generic Name, Applicant and Submission Type may be added by separating them with commas. The child folder and leaf elements of this folder complete the remainder of the jp-regional-index.xml file.

Jordan

Extension Type Associated Attributes Applied to Assembly Element Result
JO Module 1 folder (v1.0, v1.1) No additional attributes JO Module 1 folder in JO Module 1 assembly template When applied to an Assembly folder that is using the jo-1-0 or the jo-1.1 XML Definition file, triggers the creation of the jo-regional.xml file during publishing.
JO Module 1 Envelope Information folder (v1.0, v1.1)
  • Application Reference Number
  • UUID
  • Applicant
  • MAH
  • Agency
  • ATC
  • Submission Type
  • Submission Unit
  • Procedure
  • Invented Name
  • INN
  • Sequence
  • Related Sequence
  • Submission Description
  • Number
JO Envelope Information folder is a child of the JO Envelope Information leaf in JO Module 1 assembly template. Attribute values provided for each folder with this type complete the envelope information within the jo-regional.xml file. Multiple comma-separated values can be provided for:
  • Application Reference Number
  • ATC
  • Invented Name
  • INN
  • Related Sequence
JO Product Information folder
  • Language
  • Product Information Type
In JO Module 1 assembly template, applied to the product information subfolders of the following folders:
  • 1.3.1 Arabic SPC
  • 1.3.1 English SPC
  • 1.3.1 Arabic SPC-comp
  • 1.3.1 English SPC-comp
  • 1.3.2 Arabic
  • 1.3.2 English
  • 1.3.3 Arabic Patient Information Leaflet (PIL)
  • 1.3.3 Arabic Patient Information Leaflet (COMP)
  • 1.3.3 English Patient Information Leaflet (PIL)
  • 1.3.3 English Patient Information Leaflet (COMP)
Populates the labeling and language attribute of the <pi-doc> element within appropriate elements in the jo-regional.xml file. Also includes appropriate language values in the output directory structure.
JO Additional Information folder No additional attributes Additional Data folder in JO Module 1 assembly template Creates the appropriate <m1-additional-data> element in the jo-regional.xml file.

Switzerland

Extension Type Associated Attributes Applied to Assembly Element Result
CH Module 1 folder (v1.2 , v.1.3, and v1.4)
  • Application Number
  • Submission Description
  • Invented Name
  • DMF Number
  • PMF Number
  • INN
  • Applicant
  • DMF Holder
  • PMF Holder
  • Agency
  • Submission Type
  • Paragraph 13 TPA
  • Sequence Number
  • Related Sequence
1 Administrative Information and Prescribing Information folder in CH Module 1 assembly template When applied to a folder in an Assembly that is using the ch-1-2, ch-1-3, or ch-1-4 XML Definition file, triggers the creation of the ch-regional.xml file during publishing. The values of the attributes populated on this folder are used to complete the values of the elements and attributes in the <ch-envelope> element of the ch-regional.xml file. Multiple comma-separated values can be provided for:
  • Application Number
  • Invented Name
  • INN
  • Related Sequence

The child folders of this folder complete the remainder of the ch-regional.xml file.

CH Module 1 folder (v1.5)
  • Application Number
  • Submission Description
  • Invented Name
  • DMF Number
  • PMF Number
  • INN
  • Applicant
  • DMF Holder
  • PMF Holder
  • Agency
  • Submission Type
  • Article 13 TPA
  • Sequence Number
  • Related Sequence
1 Administrative Information and Prescribing Information folder in CH Module 1 assembly template When applied to a folder in an Assembly that is using the ch-1-5 XML Definition file, triggers the creation of the ch-regional.xml file during publishing. The values of the attributes populated on this folder are used to complete the values of the elements and attributes in the <ch-envelope> element of the ch-regional.xml file. Multiple comma-separated values can be provided for:
  • Application Number
  • Invented Name
  • INN
  • Related Sequence

The child folders of this folder complete the remainder of the ch-regional.xml file.

CH Galenic Form folder
  • Galenic Form Name
  • SwissMedic Number
  • Galenic Language Name
  • Galenic Language Text
Galenic Form folder in CH Module 1 assembly template Creates the <galenic-form> element within the <envelope country="ch"> element in the ch-regional.xml. If there are leafs submitted under the subfolders of the folder with this extension applied, creates the <m1-galenic-form> element in the ch-regional.xml file. The values of the attributes populated on this folder are used to complete the attributes of <galenic-form> and <m1-galenic form> elements.
CH Common Form folder No additional attributes Common folder in CH Module 1 assembly template Creates the <m1-galenic-form> element in the ch-regional.xml file with the name="common" attribute populated.
CH Swiss Responses folder No additional attributes Responses to Swissmedic LoQ folder in CH Module 1 assembly template Creates the appropriate <m1-swiss-responses> element in the ch-regional.xml file.
CH Additional Data folder No additional attributes Additional Information in CH Module 1 assembly template Creates the appropriate <m1-additional-data> element in the ch-regional.xml file.

Gulf Cooperation Council

Extension Type Associated Attributes Applied to Assembly Element Result
GCC Module 1 folder (v1.5) No additional attributes GCC Module 1 folder in GCC Module 1 assembly template When applied to an Assembly folder that is using the gc-1-5 XML Definition file, triggers the creation of the gc-regional.xml file during publishing. The child folders of this folder complete the content included in the gc-regional.xml file. Multiple comma-separated values can be provided for:
  • Application Number
  • ATC
  • Invented Name
  • INN
  • Related Sequence
GCC Module 1 folder (v1.2) No additional attributes GCC Module 1 folder in GCC Module 1 assembly template When applied to an Assembly folder that is using the gc-1-2 XML Definition file, triggers the creation of the gc-regional.xml file during publishing. The child folders of this folder complete the content included in the gc-regional.xml file.
GCC Module 1 Envelope Information folder (v1.5)
  • Country
  • Application Number
  • Applicant
  • Agency Name
  • ATC
  • Submission Type
  • Submission Unit Type
  • Procedure Type
  • Invented Name
  • INN
  • Sequence
  • Related Sequence
  • Submission Description
Depending on the procedure type/template selected, there will be appropriate CC Envelope Information folder(s) that is a child of the CC Envelope Information leaf in GCC Module 1 assembly template. A folder for each country applicable in the sequence should be included to provide the appropriate envelope information. Attribute values provided for each folder with this type complete the envelope information for the country specified within the gc-regional.xml file. You must create a separate folder for each country for which envelope information is being provided. These folders should reside beneath the GCC Envelope Information leaf. This is to ensure proper behavior during life cycle updates. Multiple comma-separated values can be provided for:
  • Application Number
  • ATC
  • Invented Name
  • INN
  • Related Sequence
GCC Module 1 Envelope Information folder (v1.2)
  • Country
  • Application Number
  • Applicant
  • Agency Name
  • ATC
  • Submission Type
  • Procedure Type
  • Invented Name
  • INN
  • Sequence
  • Related Sequence
  • Submission Description
Depending on the procedure type/template selected, there will be appropriate CC Envelope Information folder(s) that is a child of the GCC Envelope Information leaf in GCC Module 1 assembly template. A folder for each country applicable in the sequence should be included to provide the appropriate envelope information. Attribute values provided for each folder with this type complete the envelope information for the country specified within the gc-regional.xml file. You must create a separate folder for each country for which envelope information is being provided. These folders should reside beneath the GCC Envelope Information leaf. This is to ensure proper behavior during life cycle updates. Multiple comma-separated values can be provided for:
  • Application Number
  • ATC
  • Invented Name
  • INN
  • Related Sequence
GCC Country-Specific Information folder
  • Country
  • Language
In GCC Module 1 assembly template, applied to the country-specific subfolders of the following folders:
  • 1.0 Cover Letter Application Form Summary of Product Characteristics (SPC)
  • 1.3.2 Labeling
  • 1.3.3 Patient information leaflet
  • 1.3.4 Artwork (mock-ups)
  • 1.3.5 Samples
  • 1.7.4 Certificate of analysis - Excipients
  • 1.7.5 Alcohol-content declaration
  • 1.7.6 Pork-content declaration
  • 1.7.7 Certificate of suitability for TSE
  • 1.7.8 The diluents and coloring agents in product formula
  • 1.7.9 Patent Information
  • 1.7.10 Letter of access or acknowledgements to DMF
  • 1.8.1 Price list
  • 1.8.2 Other documents related
Populates the country attribute of the <specific> element within appropriate elements in the gc-regional.xml file. Also includes appropriate country information values in the output directory structure.
GCC Label folder
  • Country
  • Language
  • Labeling Type
In GCC Module 1 assembly template, applied to the language specific subfolders of the following folders:
  • 1.3.1 Summary of Product Characteristics (SPC)
  • 1.3.2 Labeling
  • 1.3.3 Patient information leaflet
Populates attributes for the <pi-doc> element within appropriate elements in the gc-regional.xml file. Also includes appropriate language values in the output directory structure.
GCC Responses folder Country 1.9 Responses to Questions folder in GCC Module 1 assembly template Creates the appropriate <m1-9-responses> element in the gc-regional.xml file with country values for the <specific> child element. Also includes appropriate country information values in the output directory structure.
GCC Additional Data folder Country Additional Data folder in GCC Module 1 assembly template Creates the appropriate <m1-additional-data> element in the gc-regional.xml file with country values for the <specific> child element. Also includes appropriate country information values in the output directory structure.

South Africa

Extension Type Associated Attributes Applied to Assembly Element Result
ZA Module 1 folder v3.1
  • Application Type
  • Application ID
  • Application Number
  • Proprietary Name
  • Dosage Form
  • INN
  • APIMF Number
  • PMF Number
  • VAMF Number
  • SMF Number
  • Submission (Submission Type/Evaluation Pathway/Submission Lead/Submission Number
  • Sequence Type
  • Sequence Description
  • Sequence Date
  • Sequence Number
  • Related Sequence
  • Multiple Applications (Application Number/Proprietary Name)
  • Contact
1 Administrative Information and Prescribing Information folder in ZA Module 1 assembly template When applied to a folder in an Assembly that is using the za-3-1 Definition file, triggers the creation of the za-regional.xml file during publishing. The values of the attributes populated on this folder are used to complete the values of the elements and attributes in the <za-envelope> element of the za-regional.xml file. Multiple comma-separated values can be provided for:
  • SMF Number
  • Application Number
  • Dosage Form
  • INN
  • APIMF Number
  • VAMF Number
  • Proprietary Name
  • PMF Number
  • Related Sequence
Note: Multiple paired values can be provided for the Multiple Applications attribute. While Multiple Applications is not required (both Application Number and Proprietary Name can be empty) it is required to have both values either populated or empty. If only one field is populated, a validation message is displayed.

The child folders of this folder complete the remainder of the za-regional.xml file.

ZA Module 1 folder v2.1
  • Application Number
  • Applicant
  • Submission Type/Proof of Efficacy
  • Proprietary Name
  • Dosage Form
  • INN
  • eCTD Sequence
  • Related Sequence
  • Duplicated Applications (Proprietary Names/Application Numbers)
1 Administrative Information and Prescribing Information folder in ZA Module 1 assembly template When applied to a folder in an Assembly that is using the za-2-1 Definition file, triggers the creation of the za-regional.xml file during publishing. The values of the attributes populated on this folder are used to complete the values of the elements and attributes in the <za-envelope> element of the za-regional.xml file. Multiple comma-separated values can be provided for:
  • Application Number
  • Proprietary Name
  • Dosage Form
  • INN
  • Related Sequence

The child folders of this folder complete the remainder of the za-regional.xml file.

ZA Module 1 folder v1.0
  • Application Number
  • Applicant
  • Submission Type
  • Proof of Efficacy
  • Proprietary Name
  • Dosage Form
  • INN
  • eCTD Sequence
  • Related Sequence
  • Duplicated Applications (Proprietary Names/Dates of Application
1 Administrative Information and Prescribing Information folder in ZA Module 1 assembly template When applied to folder in an Assembly that is using the za-1-0 Definition file, triggers the creation of the za-regional.xml file during publishing. The values of the attributes populated on this folder are used to complete the values of the elements and attributes in the <za-envelope> element of the za-regional.xml file. Multiple comma-separated values can be provided for:
  • Application Number
  • Proprietary Name
  • Dosage Form
  • INN
  • Related Sequence

The child folders of this folder complete the remainder of the za-regional.xml file.

Australia

Extension Type Associated Attributes Applied to Assembly Element Result
AU Module 1 folder (v3.1)
  • e-Identifier
  • eBS Client ID
  • Approved Name(s)
  • Trade Name(s)
  • ARTG Number(s)
  • Submission or Application Number(s)
  • Sequence Number
  • Related Sequence Number
  • Regulatory Activity Lead
  • Submission Mode
  • Sequence Type
  • Sequence Description
  • Contact Email
1 Administrative Information and Prescribing Information folder of the AU eCTD template When applied to a folder in an Assembly that is using the au-3-1 Definition file, triggers the creation of the au-regional.xml file during publishing. The values of the attributes populated on this folder are used to complete the values of the elements and attributes in the <au-envelope> element of the au-regional.xml file. Multiple, comma-separated values can be provided for:
  • Approved Name
  • Trade Name
  • ARTG Number
  • Submission or Application Number
  • Contact Email

The child folders of this folder complete the remainder of the au-regional.xml file.

AU Module 1 folder (v0.90 and v3.0)
  • eSubmission Identifier
  • Applicant
  • Australian Approved Name(s)
  • Product Name
  • ARTG Number
  • Sequence Description
  • Sequence Number
  • Related Sequence Number
  • Regulatory Activity Lead
  • Sequence Type
1 Administrative Information and Prescribing Information folder of the AU eCTD template When applied to a folder in an Assembly that is using the au-0-90 or au-3-0 Definition file, triggers the creation of the au-regional.xml file during publishing. The values of the attributes populated on this folder are used to complete the values of the elements and attributes in the <au-envelope> element of the au-regional.xml file. Multiple, comma-separated values can be provided for:
  • Australian Approved Name(s)
  • Product Name
  • ARTG Number

The child folders of this folder complete the remainder of the au-regional.xml file.

Thailand

Extension Type Associated Attributes Applied to Assembly Element Result
TH Module 1 folder (v1.0)
  • eSubmission Identifier
  • Sequence Type
  • Regulatory Activity Lead
  • Licensee Number
  • Licensee Type
  • Licensee Name
  • INN/Generic Name
  • Product Name
  • Sequence Number
  • Related Sequence Number
  • Sequence Description
  • Contact Email
1 Administrative Information and Prescribing Information folder of the TH eCTD template When applied to a folder in an Assembly that is using the th-1-0 Definition file, triggers the creation of the th-regional.xml file during publishing. The values of the attributes populated on this folder are used to complete the values of the elements and attributes in the <envelope> element of the th-regional.xml file. Multiple, comma-separated values can be provided for:
  • INN/Generic Name
  • Product Name

The child folders of this folder complete the remainder of the th-regional.xml file.

TH Module 1 folder (v0.92)
  • eSubmission Identifier
  • Sequence Type
  • Regulatory Activity Lead
  • Licensee
  • INN/Generic Name
  • Product Name
  • Sequence Number
  • Related Sequence Number
  • Sequence Description
1 Administrative Information and Prescribing Information folder of the TH eCTD template When applied to a folder in an Assembly that is using the th-0-92 Definition file, triggers the creation of the th-regional.xml file during publishing. The values of the attributes populated on this folder are used to complete the values of the elements and attributes in the <envelope> element of the th-regional.xml file. Multiple, comma-separated values can be provided for:
  • INN/Generic Name
  • Product Name

The child folders of this folder complete the remainder of the th-regional.xml file.

Taiwan

Extension Type Associated Attributes Applied to Assembly Element Result
TW Module 1 folder (v1.0)
  • Identifier
  • Submission Type Tier 1
  • Submission Type Tier 2
  • Submission Type Tier 3
  • Submission Type Tier 4
  • Submission Type Tier 5
  • Submission Objective
  • Submission Unit
  • Applicant Name
  • Applicant Corporate Certification Authority
  • Applicant Phone Number
  • Applicant Email Address
  • Invented Names (Name/Drug Permit License/ Pre-Assigned Application Number)
  • Code
  • INN
  • Sequence
  • Related Sequence
  • Submission Description
1 Administrative Information and Prescribing Information folder of the TW eCTD template When applied to a folder in an Assembly that is using the tw-1-0 Definition file, triggers the creation of the tw-regional.xml file during publishing. The values of the attributes populated on this folder are used to complete the values of the elements and attributes in the <envelope> element of the tw-regional.xml file.

The child folders of this folder complete the remainder of the tw-regional.xml file.

Multiple comma-separated values can be provided for:
  • Applicant Phone Number
  • Applicant Email Address
  • Invented Names
  • Drug Permit License
  • INN
  • Related Sequence

World Health Organization (WHO)

Extension Type Associated Attributes Applied to Assembly Element Result
WHO Module 1 folder (v1.0)
  • Identifier
  • Product Type
  • Product Subtype
  • Product Name
  • Application Type
  • Application Subtype
  • Submission Unit Type
  • Applicant
  • Contact Email
  • Product ID
  • SF Case ID
  • Sequence
  • Related Sequence
  • Submission Description
1 Administrative Information and Prescribing Information folder of the WHO eCTD template When applied to a folder in an Assembly that is using the who-1-0 Definition file, triggers the creation of the whopqt-regional.xml file during publishing. The values of the attributes populated on this folder are used to complete the values of the elements and attributes in the <envelope> element of the whopqt-regional.xml file.

The child folders of this folder complete the remainder of the whopqt-regional.xml file.

Multiple comma-separated values can be provided for:
  • Contact Email Address
  • Related Sequence