United States-v3.3
| Attribute | Description |
| Applicant Contact | The Applicant Contact for the submission. |
| Applicant ID |
The D-U-N-S® number identifier for the business entity that is the sponsor, applicant, or holder of the submission.The same D-U-N-S number should be used for all submissions to an application, unless there is a change in ownership of the application. The default value is taken from the Application level value. If not defined at the Application level, the default for United States region in Data Administration is used. |
| Application Contains Files? | Indicates if the application contains the files in a grouped submission. |
| Application Number | The application number provided by the agency. |
| Application Type | The type of application. |
| Company Name | The sponsor or applicant name. |
| Cross-Reference Application |
The application number and type of cross-reference applications. Should only be provided when an application makes reference to other application. Multiple paired values can be provided. |
| Sequence Number | The sequence number of the submission. It should start at 0001, and should not exceed 9999. |
| Submission Description | The description of the submission to be included in the XML. |
| Submission ID | The sequence number of the first submission that refers to the same regulatory activity as the sequence that is being submitted. |
| Submission SubType | The filing/submission sub-type for the submission. Dependent on the value selected for Submission Type. |
| Submission Type | The filing/submission type for the submission. Dependent on the selected Application Type. |
|
Supplement Effective Date Type |
The supplement effective date type for the submission. Dependent on the selected Submission Type. |
eCTD Attributes World Health Organization
List of eCTD attributes and their description used for a submission.
World Health Organization-v1.0
| Attribute | Description |
| Identifier | The Universally Unique identifier (UUID) identifies the instances submitted by eCTD |
| Product Type | Product code for product type |
| Attribute | Description |
| Product Subtype | Description of the product type. Mandatory for FPP only. |
| Product Name | The name or proposed product (trade) name used on the Certificate of Registration. |
| Application Type | Administrative information associated with a submission. The type of regulatory activity to which the content is submitted. |
| Application Subtype | Provides further information about a submission. Mandatory for FPP. |
| Submission Unit Type | Submission unit type describes the content at a lower level (a "sub-activity") that is submitted in relation to a defined regulatory activity. |
| Applicant | The name of the company submitting the eCTD. |
| Contact Email | Email address of the contact or an applicant. |
| Product ID | Unique product record identifier, following the format WHO Product ID: Issued by Salesforce. |
| SF Case ID | A Salesforce generated number, unique to the application submitted. It follows a simple 8 digit number format. |
| Sequence | Sequence number for a submission. |
| Related Sequence | This is the sequence number of previous submission(s) to which this submission relates. For example., the responses to questions to a particular variation. In the case of submission unit types 'initial' and 'reformat' related sequence is identical to the sequence number. |
| Submission Description | Description of a Submission included in the XML. |
Repeatable Assembly Sections
The eCTD assembly contains repeatable sections and captures section-specific metadata for their associated extended type.
| Assembly section number | Assembly section name | Associated extended type |
| 1.15.2.1 | Material | Promotional Material Type |
| N/A | Galenic Form | CH Galenic Form |
| 2.3.S | Drug Substance | Drug Substance |
| 2.3.P | Drug Product | Drug Product |
| 2.7.3 | Clinical Indication | Clinical Indication |
| 3.2.S | Drug Substance | Drug Substance |
| 3.2.P | Drug Product | Drug Product |
| 3.2.P.4 | Excipient | Excipient |
| Assembly section number | Assembly section name | Associated extended type |
| 3.2.A.1 | Quality Appendix | Quality Appendix |
| 3.2.A.2 | Quality Appendix | Quality Appendix |
| 3.2.A.3 | Excipient | Excipient |
| 5.3.5 | Clinical Indication | Clinical Indication |
Submission Metadata
You can use the attributes to enter submission metadata on the Set Submission Metadata page in the Create eCTD wizard.
| Metadata | Description |
| Dosage Form | The dosage form (e.g.: liquid, capsules). |
| Drug Product Manufacturer | Enter the name of the manufacturer for the marketing name product. |
| Drug Product Name | The Marketing Name for the product. |
| Drug Substance Manufacturer | The name of the manufacturer for the active ingredient of the product. |
| Drug Substance Name | The active ingredient for the product. |
| Excipient | The nonactive substance for the product. |
| Galenic Form Name | The name of the galenic form. |
| Galenic Language Name | The language of the galenic form. |
| Galenic Language Text | The galenic language text. |
| Indication | The disease or medical problem for which the drug is used. |
| Manufacturer | The name for the marketing manufacturer. |
| Product Name | The marketing name for the product. |
| Promotional Material ID | The applicant identification code or other designation of the specific promotional material. |
| Promotional Material Type | Defines the promotional material document type. |
| Substance | The active ingredients for the product. |
| SwissMedic Number | The number for the galenic form from the SwissMedic agency. 5digits, or 'pending'. |
| Update the sub-folder structure for |
If selected, set submission structure for selected nodes is updated with missing folders and their children. If no folders are missing but leaf elements are missing in the assembly, the update has no effect. The wizard checks for folders only. |