TGA Business services - how to use the site
Update on access to TGA Business Services for clinical trial sponsors
The TGA Business Services (TBS) system allows for different structures and relationships to be developed.
The type of access structure that sponsors set up in TBS will determine who can see Clinical Trial Notification (CTN) form information. You can control the visibility of CTN information within your organisation by choosing the appropriate access framework currently available on the TBS system.
The TGA Business Services site allows industry to manage some therapeutic good registration applications, and view and cancel their current entries on the Australian Register of Therapeutic Goods (ARTG). Sponsors are able to view, download and print ARTG Register entries for their products and generate certificates online.
Clients can also keep up to date with the latest TGA-wide and Industry specific news - directly from the site.
To apply for access to TGA Business Services please see the TGA Business services: getting started with the TGA.
For those who frequently report adverse events to the TGA, the TGA Business Services site also provides registered users with access to the Australian Adverse Drug Reaction Reporting System (ADRS). Please refer to the specific Information for registered users of the Australian Adverse Drug Reaction Reporting System for further details. If you do not report adverse events on a regular basis, but you still wish to report online, you can report via ADRS as a non-registered user. Reporting as a non-registered user will mean that you do not need to maintain login and password details.
General questions and answers
Watch our video: Welcome to the TGA Business Services site.
- Click on Reset password on the login screen.
- Enter your email address or user ID and click reset. An email will be sent to the email address registered to the account.
- Click the link within this email and you will be sent to a new screen to enter a new password.
You have 24 hours to reset your password once you receive the email.
- Contain a minimum of 10 characters
- Have three of the following four categories
- English uppercase characters (A to Z)
- English lowercase characters (a to z)
- Numbers (0 to 9)
- Non-alphabetic characters (for example; !, $,#,%).
Passwords must not:
- Contain your account name or more than two consecutive characters of your full name.
- Be the same as your last eight passwords.
You can change your password once a day.
Click on View my organisation then on View all contacts. You will be presented with a list of Active and Inactive Organisation Contacts.
Each Contact will show:
You can refine the list by typing in the search field.
Click on View my organisation then on View all contacts. The list of Organisation Contacts will be displayed.
Click on View my organisation then on View all connections. The list of Organisation Connections will be displayed.
Yes, the terms and conditions are available on the TGA Business Services (TBS) Terms and Conditions page.
If you are within the application section, you will need to return to your dashboard before you can sign out.
Click Back to Business Portal in the menu on the left hand side.
Then to sign out:
- Click on your name on the top right hand side of the screen. A menu will be displayed.
- Select Sign out
- Close your browser including all tabs to complete the sign out process.
Roles: what each user can do
Individuals can have multiple system roles. For example, an Administrator with Financial access can do all of the tasks for both roles.
|Dashboard||Yes 1||Yes 1||Yes 1||Yes 1|
|News||Yes 1||Yes 1||Yes 1||Yes 1|
|View organisation contact||Yes||Yes||Yes||Yes|
|View organisation connections||Yes||Yes||Yes||Yes|
|Update my contact details||Yes||Yes||Yes||Yes|
|Search for organisation contact||Yes||Yes||Yes||Yes|
|Reset my password||Yes||Yes||Yes||Yes
Also resets other users' passwords within their organisation.
|View drafts and submissions||Yes 2||Yes 2||No||No|
|Activate/deactivate organisation contact||No||No||No||Yes|
|Update organisation details||No||No||No||Yes|
|Assign/modify roles||No||No||No||Yes 3|
|View invoices and make payments||No||No||Yes||No|
- Customised for each role
- If there are multiple Drafters/Submitters for a single TBS Client ID, each of these people will be able to view the drafts/submissions of their colleagues.
- Administrators cannot assign the Administrator role to another contact within their organisation.