To create a new application, click + Add New Application on the main Publish page.
The first step of the Application Wizard contains the following fields.
Region - From the dropdown menu, choose the region to associate with the application.
Version - Choose the format/version desired per the selected region.
Note - Currently, these two regions have two eCTD version options available to select from.
Region | eCTD version |
Japan | 1.0 and 4.0 |
United States | 3.3 and 4.0 |
Click on the region sections below to continue reading about region-specific information for the application.
Australia (TGA)
Australia (TGA)
Application Information
For the region of Australia, the second page of the Application Wizard contains the following fields.
Field name | Details/Purpose |
Application number | Must begin with a lowercase letter followed by six digits. |
Approved names | Name of the active ingredient(s) that are accepted for inclusion in the Australian Approved Name list. Also known as a generic name. |
Product names | Name or proposed medicine (trade) name to be used on the Certificate of Registration. |
ARTG numbers (Optional) | All applicable ARTG numbers (if available). This can be a four-, five-, or six-digit number. Use the '+' icon to add all the available numbers as a list. |
Submission Information
The third page of the Application Wizard contains the following fields.
Field name | Details/Purpose |
Sequence number | Unique four-digit number, generally the next number in the sequence (0000 is typically used for the first sequence). |
Applicant | The name of your company
|
Regulatory activity type | Choose from the list provided as per the specific region. |
Sequence type | Choose from the region-specific list provided. The dropdown options visible are aligned to the option selected under Regular activity type in the previous step. |
Regulatory activity lead | Choose from the list provided. |
Regulatory activity in | Allows you to assign an application and regulatory activity to the submission you are creating
|
Sequence description type | Select from the pre-defined list provided in dropdown as per the sequence type selected above. |
Emails* | Enter the email address of the individual that serves as the point-of contact to the health authority. To add more than one email id, use the '+' icon on the right. |
Submission numbers* | The submission number(s) are applicable to the sequence being submitted. These should be provided as follows: PM-2017-12345-1-5 Prescription medicines submission numbers: Prefix PM followed by the submission number and stream. If the submission number is not yet known it is appropriate to only include the prefix and the stream i.e., PM-1. NOTE that this will apply whether the activity refers to a biological medicine or other molecular type (‘chemical’ medicine). BA-2017-12345-1 Biologicals submission numbers: Prefix BA followed by the submission number. If the submission number is not yet known it is appropriate to only include the prefix e.g. BA. OM-2017-12345-1 OTC medicines submission numbers: Prefix OM followed by the submission number. If the submission number is not yet known it is appropriate to only include the prefix e.g. OM. Complementary Medicines: For registered complementary medicines the same protocol applies as for OTC medicines as detailed above. For listed complementary medicines no validation is planned at this time. PV Pharmacovigilance: No submission number is assigned; PV should be entered for all sequences where pharmacovigilance information is submitted. MF Master Files: No submission number is assigned; MF should be entered for all sequences where master file information is submitted. MD Medical Devices: Depending on whether the eCTD application is a device application or a conformity assessment, the prefix should be DA or DC e.g. DA-2017-12345-1. |
Add existing repeat sections | Refer to 'Add existing repeat sections' under the topic Manage a Submission Unit. |
* These fields are to be filled mandatorily without which the 'Create' button remains disabled in the application wizard
Brazil (ANVISA)
Brazil (ANVISA)
The browser-based Publish currently supports both NeeS and eCTD v4.0 applications for the Brazilian region.
eCTD v4.0
Application Information
Field | Description |
Application type | Choose one of the predefined types of applications from the dropdown options. |
ANVISA Process Number | A unique numerical tracking code generated automatically upon the electronic submission of a petition or product registration application to the ANVISA. It serves as the official identifier for monitoring regulatory filings, technical reviews, and compliance status in Brazil. Format: Typically structured as a 17-digit string (e.g., 25351.XXXXXX/YYYY-ZZ) representing the subject code, sequential identifier, year, and verification digits. |
Do not autocorrect PDFs for this application? | Refer to 'Do Not Auto correct PDF Functionality' under the topic Manage Applications. |
Click Next to go to the third step and enter submission information.
The third page of the Application Wizard contains the following fields.
Submission Information
Field | Description |
Submission-unit number | Numeric starting at 1, 2, etc.
|
Submission-type | Choose the type of submission from the dropdown list. |
Submission unit type | Choose the type of submission unit. Options available depend on the selected submission type. |
ANVISA Expedient Number | A unique tracking identifier assigned by the ANVISA to every electronic petition, application, or dossier submission (such as a GMP certificate request, product registration, or post-approval change). |
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 |
Nees:
The second step of the Application Wizard contains the following fields.
Product Name: 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
Sequence Number: Unique four-digit number, generally the next number in the sequence, (0000 is typically used for the first sequence).
Canada (Health Canada)
Canada (Health Canada)
Application Information
For the region Canada, the second page of the Application Wizard contains the following fields.
Field name | Details/Purpose |
Application type | Select in the dropdown from one of the 3 options below:
|
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. |
Submission Information
The third page of the Application Wizard contains the following fields.
Field name | Details/Purpose |
Sequence number | Unique four-digit number, generally the next number in the sequence. The first sequence must be 0000 and subsequent sequences must be in ascending numerical order. |
Applicant | The name of your company
|
Regulatory activity type | Choose from the list provided as per the specific region. |
Sequence type | Choose from the region-specific list provided. The dropdown options visible are aligned to the option selected under Regular activity type in the previous step. |
Regulatory activity lead | Choose from the list provided. |
Regulatory activity in | Allows you to assign an application and regulatory activity to the submission you are creating
|
Add existing repeat sections | Refer to 'Add existing repeat sections' under the topic Manage a Submission Unit. |
China
China
Application Information
For the region China, the second page of the Application Wizard contains the following fields.
Field name | Details/Purpose |
Application type | Select in the dropdown from one of the 3 options below:
|
Application number | Enter the specific letter followed by nine numeric digits as provided by China's Health authority in response to a request for an application number. Application number format varies with respect to the Application type selected in the previous step.
|
Submission Information
The third page of the Application Wizard contains the following fields.
Field name | Details/Purpose |
Sequence number | Unique four-digit number, generally the next number in the sequence (0000 is typically used for the first sequence) |
Regulatory activity type | Choose from the list provided in dropdown as per the specific region |
Regulatory activity in | Allows you to assign an application and regulatory activity to the submission you are creating
|
Sequence type | Choose from the region-specific list provided. |
Product type | Choose from the list available in the dropdown. |
Product number | Enter the appropriate number (Must be exactly 10 digits) |
Contact name | Enter name of the individual that serves as the point-of contact to the health authority |
Contact phone | Enter phone number of the individual that serves as the point-of contact to the health authority |
Contact email | Enter email address of the individual that serves as the point-of contact to the health authority |
Description | Briefly describe the submission contents |
Add existing repeat sections | Refer to 'Add existing repeat sections' under the topic Manage a Submission Unit. |
European Union (EMA)
European Union (EMA)
The browser-based Publish now allows users to work on both eCTD v3.1.1 and NeeS applications as per EU guidance.
eCTD v3.1.1
eCTD v3.1.1
For the European region, the second page of the Application Wizard contains the following fields for eCTD v3.1.1.
Field name | Details/Purpose |
Sponsor Identifier | Universal Unique Identifier (UUID).
You can use the 'Refresh' toggle to generate random id, if the identifier is not known. |
Procedure | Choose from the dropdown list available |
Agencies | Fields displayed as per the Procedure selected in previous step.
Use the '+ ADD AGENCY' option to include more than one agency |
International Non-Proprietary Names (INN) | Enter a unique, globally recognized, and nonproprietary (generic) name for an active pharmaceutical ingredient, designated by the World Health Organization (WHO) Use the '+ ADD INN' option to include more than one name |
Invented Names | Enter proprietary or brand names proposed for the product to be used on the Certificate of Registration
Use the '+ ADD INVENTED NAME' option to include more than one name |
Note - all fields are mandatory to be filled in the second page.
Click Next to go to the third step and enter submission information.
The third page of the Application Wizard contains the following fields.
Field name | Details/Purpose |
Sequence number | Unique four-digit number, generally the next number in the sequence. The first sequence must be 0000 and subsequent sequences must be in ascending numerical order. |
Applicant | The name of your company
|
Regulatory activity type | 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. |
Mode (Optional) | This field can have a value in variation or line extension regulatory activities and must be included in every sequence of that activity.
|
High level number (Optional) | Must be provided based on the type of Mode selected previously.
|
Tracking Numbers | Enter a number used by European Medicines Agency to track the submission, in any procedure, in relation to the product. This could be one or more of the following:
|
Add existing repeat sections | Refer to 'Add existing repeat sections' under the topic Manage a Submission Unit. |
Finally, press Create to create the application.
NeeS
NeeS
For the European region, the second page of the Application Wizard contains the following fields for Nees application.
Product Name: 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
Sequence Number: Unique four-digit number, generally the next number in the sequence, (0000 is typically used for the first sequence).
Finally, press Create to create the application.
Gulf Cooperation Council (GCC)
Gulf Cooperation Council (GCC)
Application Information
For the GCC region, the second page of the Application Wizard contains the following fields.
Field name | Details/Purpose |
Application folder | Name for the folder where the application will be saved. |
Procedure | Choose from the dropdown list - GCC (or) National |
Agencies | Select from the list provided based on the country associated with the eCTD application's regulatory authority Use the '+ ADD AGENCY' option to include more than one agency |
International Non-Proprietary Names (INN) | Enter a unique, globally recognized, and nonproprietary (generic) name for an active pharmaceutical ingredient, designated by the World Health Organization (WHO) Use the '+ ADD INN' option to include more than one name |
Invented Names | Enter proprietary or brand names proposed for the product to be used on the Certificate of Registration |
Anatomical Therapeutic Classifications (Optional) | This ATC classification component ensures medicines are accurately categorized, routed to the appropriate expert review teams, and consistently evaluated across GCC joint registration processes. |
Note - all fields are mandatory to be filled in the second page except ATC.
Submission Information
The third page of the Application Wizard contains the following fields.
Field name | Details/Purpose |
Applicant | The name of your company
|
Sequence number | Unique four-digit number, generally the next number in the sequence. The first sequence must be 0000 and subsequent 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 (optional) | Allows you to assign an application and regulatory activity to the submission you are creating
|
Description | Briefly describe the submission. |
Application Numbers | Any number, used by an agency or the applicant to track the submission, in any procedure, in relation to a particular product. This field aligns with the agency previously selected in second page. |
Add existing repeat sections | Refer to 'Add existing repeat sections' under the topic Manage a Submission Unit. |
Japan
Japan
The browser-based Publish now allows users to work on both eCTD v1.0 and v4.0 as per Japan's PMDA.
Japan eCTD v1.0
Japan eCTD v1.0
For the Japan region eCTD v1.0, the second page of the Application Wizard contains the following fields.
Application Information
Field | Description |
Application number | The application number must be 9 digits. |
Brand names | 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 Use the icons to add additional brand names or delete the existing ones. |
Generic names (Optional) | Optionally, enter the generic name of the drug, if applicable. Use the icons to add more generic names or delete the existing ones. |
Click Next to go to the third step and enter submission information.
The third page of the Application Wizard contains the following fields.
Submission Information
Field | Description |
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 when sequence is being created. |
Sequence Type | Choose from the region-specific list provided |
Add existing repeat sections | Refer to 'Add existing repeat sections' under the topic Manage a Submission Unit. |
Press Create to finally create the application.
Japan eCTD v4.0
Japan eCTD v4.0
For the Japan region eCTD v4.0, the second page of the Application Wizard contains the following fields.
Application Information
Field | Description |
Application type | Choose one of the predefined types of applications. |
Reception number | Required by Japanese agency. A number provided in response to a request for an application number. |
Application number | Optional. Usually the same number as the reception number. |
Do not autocorrect PDFs for this application? | Refer to 'Do Not Auto correct PDF Functionality' under the topic Manage Applications. |
Click Next to go to the third step and enter submission information.
The third page of the Application Wizard contains the following fields.
Submission Information
Field | Description |
Submission-unit number | 4.0 and higher guidance: Numeric starting at 1, 2, etc. Pre-4.0 guidance: Unique four-digit number, generally the next number in the submission unit (0000 is typically used for the first submission unit). |
Submission-type | Choose the type of submission from the list. |
Submission unit type | Choose the type of submission unit. Options available depend on the selected submission type. |
Category event | Choose an event category that describes the reason for the submission. |
Initial submission-type (optional) | If Category event is set to Initial submission of eCTD, choose the type of submission unit. |
Organization | 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. |
Application references | Optionally reference other applications by entering the Reception number of the application being referenced and selecting one or more predefined Reasons for referencing the application. Use the icons to add another reference or delete the reference. |
Click Next to go to the fourth step and enter product information.
The fourth and final page of the Application Wizard includes:
Product Information
Click + Add Product.
Field | Description |
Product name | Enter name for the product. |
Product category | Choose one or more application classifications for the product. |
Substances | Enter the common Name of the substance involved and select the Type of name. Use the icons to add another substance or delete the substance. |
Save | Click to return to the Products popup. |
Actions
Action | Description |
+ Add Product | Continue adding products after saving each one. When all products have been added, press Create to create the application. |
Edit / Delete | Once defined, use the ... menu in the Actions column to Edit or Delete the product. |
Create | Finalizes and creates the application once all products have been added. |
Switzerland (Swiss medic)
Switzerland (Swiss medic)
Application Information
For the region of Switzerland, the second page of the Application Wizard contains the following fields.
Field name | Details/Purpose |
Application number | Number assigned to the application by Swissmedic. Must be 3 to 9 digit numbers without leading zeros. If unknown, enter 'pending' in lower case (case sensitive) |
Application folder | Name for the folder where the application will be saved. |
Products | Allows to enter Product name based on the associated Product type.
|
Substances / Dosage forms | Includes fields for the following; use the '+' icon to add a list of information
|
Submission Information
The third page of the Application Wizard contains the following fields.
Field name | Details/Purpose |
Sequence number | Unique four-digit number, generally the next number in the sequence (0000 is typically used for the first sequence) |
Applicant | The name of your company
|
Regulatory activity type | Choose from the list provided as per the specific region |
Sequence type | Choose from the region-specific list provided. The dropdown options visible are aligned to the option selected under Regular activity type in the previous step |
Description | Briefly describe the submission contents |
Regulatory activity in | Allows you to assign an application and regulatory activity to the submission you are creating
|
Drug Master File (DMF) |
|
Plasma Master File (PMF) |
|
TPA (Paragraph 13 compliant) | Check-off the box if compliant to Article 13 TPA |
United States
United States
The browser-based Publish now allows users to work on both eCTD v3.3 and v4.0 as per US FDA.
eCTD v3.3
eCTD v3.3
For the United States region eCTD v3.3, the second page of the Application Wizard contains the following fields.
Application Information
Field | Description |
Application type | Choose one of the predefined types of applications.
|
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 zeroes 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.
|
Click Next to go to the third step and enter submission information.
The third page of the Application Wizard contains the following fields.
Submission Information
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. |
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. |
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 as per the specific region. |
Sequence type | Choose from the region-specific list provided. The dropdown options visible are aligned to the option selected under Regular activity type in the previous step. |
Regulatory activity in | Allows you to assign an application and regulatory activity to the submission you are creating.
Note: You may need to set a related submission unit for your new submission unit, if it is being added to an existing Regulatory Activity.
Here are some best practices for related submission units:
|
Description | Briefly describe the submission contents. |
Click Next to go to the final step and enter contact information for individuals that serve as the points-of-contact to the health authority.
Click + Add contact.
Contact Information
Field | Description |
Name | Enter the Full name (first and last name) of the contact. |
Role | Select the contact's job at the organization using the dropdown options |
Email and phone | Select the Type of contact info being provided and enter the contact number or email address in the Value field.
|
Save | Return to the Contacts popup. |
Actions
Action | Description |
+ Add contact | Continue adding contacts after saving each one. When all contacts have been added, press Create to create the application. |
Edit / Delete | Once defined, use the ... menu in the Actions column to edit or delete the contact. |
Create | Finalizes and creates the application once all contacts have been added (For more information on contacts, see "Manage Contacts"). |
eCTD v4.0
eCTD v4.0
For the United States region eCTD v4.0, the second page of the Application Wizard contains the following fields.
Application Information
Field | Description |
Application type | Choose one of the predefined types of applications. |
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 zeroes in front of the application number to reach six digits. |
Application center | Choose one of the predefined centers to associate with the application. |
Cross Reference Applications | Identify applications to serve as references. Choose the Application type and Application center from the dropdowns, and enter the Application number in the field.
|
Do not autocorrect PDFs for this application? | Refer to 'Do Not Auto correct PDF Functionality' under the topic Manage Applications. |
Click Next to go to the third step and enter submission information.
The third page of the Application Wizard contains the following fields.
Submission Information
Field | Description |
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. |
Submission-unit number | Unique four-digit number, generally the next number in the submission unit (0000 is typically used for the first submission unit). |
Submission-type | Choose the type of submission from the list of dropdown options. |
Submission-unit type | Choose the type of submission unit. Dropdown options available depend on the selected submission type. |
Related Submission(s) | Select from the list of created submissions. |
Submission Unit Title | Enter a title for the submission unit. |
Best practices for related submission units:
Guideline | Detail |
Amendments & Resubmissions | Always choose a related submission unit number. This allows them to be grouped with top-level application types such as original applications and supplements to form regulatory activities. Related submission unit numbers cannot be entered for any other submission types. |
Single regulatory activity | Normally, a submission unit is only related to a single regulatory activity. There are rare exceptions (e.g., an amendment that applies to two supplements). |
Click Next to go to the final step and enter contact information for individuals that serve as the points-of-contact to the health authority.
Click + Add contact.
Contact Information
Field | Description |
Given name / Family name | Enter the first and last name of the contact. |
Middle name / Middle initial | Optionally enter a middle name and/or middle initial. |
Organization | Enter the name of the organization to associate with this contact or select from the list of organizations already in the system. |
Role | Select the contact's job at the organization, using the dropdown options |
Email and phone | Select the Type of contact info being provided and enter the contact number or email address in the Value field. Use the buttons on the right to insert another row or delete the row. The order in which information is entered is the order it is displayed in the Contacts tab when viewing details. |
Save | Return to the Contacts popup. |
Actions
Action | Description |
+ Add contact | Continue adding contacts after saving each one. When all contacts have been added, press Create to create the application. |
Edit / Delete | Once defined, use the ... menu in the Actions column to edit or delete the contact. |
Create | Finalizes and creates the application once all contacts have been added. (For more information on contacts, see "Manage Contacts".) |