To create a new application, begin by opening Publish and choosing New from the File menu. The Application Wizard will be displayed. Mandatory fields will be marked with an asterisk. There are three different pages that request different information depending on the selections made in previous sections.
The first page of the Application Wizard contains the following fields.
Region: From the dropdown menu, choose the region to which you want to submit to. You have the option to create an application for:
Australia
Canada
China
European Union
GCC
Japan
Swissmedic
United States
Sequence Format: Choose the format desired per the selected region. Please check with the agencies for information on what is currently supported and best practice for submission. The formats will automatically update in this dropdown after choosing a region.
After selecting the Region and Sequence Format for your application, click Next at the bottom of the Application Wizard.
The content of the remaining pages in the Wizard depends on the region specified on the first page.
Australia (TGA)
For the region of Australia, the second page of the Application Wizard contains the following fields.
Application Number: Must begin with a lowercase letter followed by six digits.
Australian Approved Name(s): Name of the active ingredient(s) that are accepted for inclusion in the Australian Approved Name list. Also known as a generic name.
Product Name(s): Name or proposed medicine (trade) name to be used on the Certificate of Registration.
ARTG Number: All applicable ARTG numbers (if available). This can be a four-, five-, or six-digit number.
The third page of the Application Wizard contains the following fields.
Applicant: The name of your company
This should always remain constant, both within an application and across application, unless there is a legitimate name change.
After you create your first application, existing value(s) will be presented in the dropdown list, for you to choose from
Data Types: Check all the applicable type of data contained within this data submission
Description: Description of the sequence’s content such as Safety Related Notification or Period Safety Update Report.
eBS: Enter the eBS number given to you
Regulatory Activity In: Allows you to assign an application and regulatory activity to the submission you are creating
Sequence Number: Unique four-digit number, generally the next number in the sequence (0000 is typically used for the first sequence).
Sequence Type: Choose from the region-specific list provided.
Canada (Health Canada)
For the region Canada, the second page of the Application Wizard contains the following fields.
Application Type
Biologic
Pharmaceutical
Drug Master File
Application Number: The letter ‘e’ followed by six numeric digits as provided by Health Canada in response to a request for an application number
Product Name: Enter the product name, i.e., the product which is being addressed in the application
The third page of the Application Wizard contains the following fields
Applicant: The name of your company
This should always remain constant, both within an application and across applications, unless there is a legitimate name change.
After you create your first application, existing value(s) will be presented in the drop
Sequence Number: Unique four-digit number, generally the next number in the sequence. The first sequence must be 0000 and subsequence sequences must be in ascending numerical order
Regulatory Activity Type: Choose from the list provided
Regulatory Activity In: Allows you to assign an application and regulatory activity to the submission you are creating.
Regulatory Activity Lead: Choose from the list provided
Sequence Type: Choose from the region-specific list provided
European Union (EMA)
For the European Union region, the second page of the Application Wizard contains the following fields.
Sponsor Identifier: Sponsor, Company Name, i.e., Synchrogenix
Procedure: Choose from the list provided
Country: The country information is automatically provided in a list to select from
Agency: Values in this list are dependent on the country selected for eCTD applications. This field is NOT required for NeeS submissions
Product Information: Enter at least one product name. Each Product Name must have an associated Product Type. At least one product of the type Invented Name must be provided.
The third page of the Application Wizard contains the following fields
Applicant: The name of your company.
This should always remain constant, both within an application and across applications, unless there is a legitimate name change.
After you create your first application, existing value(s) will be presented in the dropdown list for you to choose from.
Sequence Number: Unique four-digit number, generally the next number in the sequence, (0000 is typically used for the first sequence).
Regulatory Activity: Choose from the list provided.
Sequence Type: Choose from the region-specific list provided.
Regulatory Activity In: Allows you to assign an application and regulatory activity to the submission you are creating.
Description: Description of the sequence’s contents such as “Original MAA application” or “Responses to questions on Type II variation for ‘Treatment of Pain’ indication.”
Tracking Number: Enter a number used by an agency or yourself to track the submission, in any procedure, in relation to the product. This could be one or more of the following:
MRP/DCP number
National procedure number
EMEA application number
An authorization or license number
Any other number used by an agency to track a submission
A number used by you to manage the submission within your company
Mode: This field should have a value in variation or line extension regulatory activities and must be included in every sequence of that activity.
Enter Single, Grouping, or Work-sharing.
This information should be identical with the information provided/ticked in the application form.
High Level Number: Must be provided if Mode is Grouping or Work-sharing
For Work-sharing, enter the work-sharing number.
For Grouping, enter the group number/periodic report number
GCC
For the GCC region, the second page of the Application Wizard contains the following fields.
Procedure: Choose from the list provided.
Application Folder: Name for the folder where the application will be saved.
Country: The country information is automatically provided. Check the Active box to include that country’s information in the application.
Agency: Values in this list are dependent on the country selected for eCTD applications.
Product Information: Enter at least one product name. Each Product Name must have an associated Product Type. At least one product of the type Invented Name must be provided.
The third page of the Application Wizard contains the following fields.
Applicant: The name of your company.
This should always remain constant, both within an application and across applications, unless there is a legitimate name change.
After you create your first application, existing value(s) will be presented in the dropdown list, for you to choose from.
Sequence Number: Unique four-digit number, generally the next number in the sequence. The first sequence must be 0000 and subsequence sequences must be in ascending numerical order.
Regulatory Activity: Choose from the list provided.
Sequence Type: Choose from the region-specific list provided.
Regulatory Activity In: Allows you to assign an application and regulatory activity to the submission you are creating.
Description: Briefly describe the submission.
Application Number: Any number, used by an agency or the applicant to track the submission, in any procedure, in relation to a particular product.
Japan
For the region of Japan, the second page of the Application Wizard contains the following fields
Application Type: Jnda (Japanese New Drug Application)
Application Number: The application number must be 9 digits.
Brand Name: For the names of new drugs, guidance on the use of a flowchart to avoid use of similar names for newly approved drugs applied in the Japan Pharmaceutical Information Center (JAPIC). Manage Applications 85
The third page of the Application Wizard contains the following fields.
Applicant: The name of your company.
This should always remain constant, both within an application and across applications, unless there is a legitimate name change.
After you create your first application, existing value(s) will be present in the dropdown list for you to choose from.
Sequence Number: Unique four-digit number, generally the next number in the sequence (0000 is typically used for the first sequence).
Sequence Date: Date sequence being created.
Sequence Type: Choose from the region-specific list provided
Switzerland (Swissmedic)
For the region of Switzerland, the second page of the Application Wizard contains the following fields.
Application Number: Number assigned to the application by Swissmedic. Must be 9 digits without leading zeros. If unknown, enter pending (case sensitive)
Application Folder: Name for the folder where the application will be saved
Product Information: Enter at least two product names
Each Product Name must have an associated Product Type.
At least one product of the type Invented Name must be provided.
At least one product of the type International Non-Proprietary Name should be provided
Name: Dosage form in English. EU standard terms are strongly recommended. Lower case letters are preferred per regional standards
Galenic Name: German, French, or Italian term of the dosage form. EU standard terms are strongly recommended
Language: Select from the language list provided in a dropdown
Marketing Authorization Number: The number assigned to the product identifying the product and its galenic form
This is a 5-digit-number and is only assigned once a positive preliminary notice is issued. – If unknown, enter pending (case sensitive).
The third page of the Application Wizard contains the following fields.
Applicant: The name of your company
This should always remain constant, both within an application and across applications, unless there is a legitimate name change
After you create your first application, existing value(s) will be presented in the dropdown list for you to choose fro
Sequence Number: Unique four-digit number, generally the next number in the sequence (0000 is typically used for the first sequence).
Sequence Type: Choose from the region-specific list provided. GlobalSubmit Guide 86
Regulatory Activity In: Allows you to assign an application and regulatory activity to the submission you are creating
Description: Description of the sequence’s contents such as New Active Substance or Renewal of a Marketing Authorization
DMF Holder: The name of the company submitting the DMF. Enter n/a (case sensitive) if the submission is not a DMF
DMF: The number assigned to the DMF (alphanumeric)
Enter pending (case sensitive) if the assigned DMF number is not known. –
Enter n/a (case sensitive) if the submission is not a DMF
PMF Holder: The name of the company submitting the PMF. Enter n/a (case sensitive) if the submission is not a PMF
PMF: The number assigned to the PMF
Enter pending (case sensitive) if the assigned PMF number is not known
Enter n/a (case sensitive) if the submission is not a PMF
Article 13 TPA: Check if compliant
United States (FDA)
For the United States region, the second page of the Application Wizard contains the following fields.
Application Type
New Drug Application
Abbreviated New Drug Application
Investigational New Drug Application
Biologics License Application
Emergency Use Authorization
Application Number: Six numeric digits as provided by the FDA in response to a request for an application number. For an application previously submitted on paper, remove any dashes and add zeros in front of the application number to reach six digits.
Cross Reference Applications: Applications used for referencing. Only available for Applications using DTD version 3.3.
Product Information (Product Name and Type): Enter at least one product name. Each Product Name must have an associated Product Type. Only available for US version 2.01.
The third page of the Application Wizard contains the following fields
Applicant: The name of your company
This should always remain constant, both within an application and across applications, unless there is a legitimate name change
After you create your first application, existing value(s) will be presented in the dropdown list for you to choose from. Manage Applications 87
Contacts: Phone number and email address of the individual that serves as the point-of contact to the health authority. To configure a contact through Publish: Select the row.
In the first column, enter the name of the contact.
In the second column, specify the type of contact. Choose from:
Regulatory, Technical
United States Agent
Promotional Labeling
Advertising Regulatory Contact
After selecting type of contact, provide a number or email address by expanding this row to a sub-level by clicking on the + sign
In the first column of the sub-level, choose which contact info you want to provide:
Business telephone number
Fax number
Mobile number
Email
In the second column of the sub-level, enter the contact information.
If you want to continue adding contacts, repeat steps 1-4 above. When you click Finish, the application will be created. If you added the first sequence, the Table of Contents for the sequence will appear in Publish.
Note: This is only applicable to US DTD version 3.3.
Description: Description of the sequence’s contents.
DUNS Number: The unique nine digit numeric identifier used to identify each location of your company in the Dun and Bradstreet Database. Only applicable to US DTD version 3.3
Regulatory Activity In: Allows you to assign an application and regulatory activity to the submission you are creating
Sequence Number: Unique four-digit number, generally the next number in the sequence (0000 is typically used for the first sequence).
Sequence/Submission Type: Choose from the region-specific list provided