Page 2 of the Application Wizard
The second page of the Application Wizard collects additional information about the application required by the health authority you are submitting to. This section explains the fields available in the Application Wizard, broken down by region:
United States (FDA)
European Union (EMA)
Canada (Health Canada)
Australia (TGA)
Switzerland (SwissMedic)
Japan
• 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 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.
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.
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.
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.
Application Number: A maximum of 50 characters (numbers and letters) may be used for the application number.
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.
Application Number: A maximum of 50 characters (numbers and letters) may be used for the application number.
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 (this is case sensitive).
Application Type: Jnda (Japanese New Drug Application)
Application Number: A maximum of 50 characters (numbers and letters) may be used for the application number.
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).
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