Question 1

What does Assyro support for TGA submissions?

Accepted Answer

Assyro supports submissions to the Therapeutic Goods Administration (TGA), Australia. Your Australian filing runs in the same workspace as your FDA, Health Canada, and EMA submissions. Book a demo to walk through your Australian program.

Question 2

What is the TGA?

Accepted Answer

The Therapeutic Goods Administration (TGA) is Australia's regulator for therapeutic goods, including prescription medicines, biologicals, and medical devices, under the Therapeutic Goods Act 1989. Products must be entered on the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia.

Question 3

What is the ARTG?

Accepted Answer

The Australian Register of Therapeutic Goods (ARTG) is the TGA's register of therapeutic goods that can be lawfully supplied in Australia. A medicine, biological, or medical device must be entered on the ARTG before it is supplied, unless an exemption applies.

Question 4

How do you register a medicine with the TGA?

Accepted Answer

An Australian sponsor, meaning an Australian resident or a company doing business in Australia, applies to the TGA to enter the product on the ARTG. For a prescription medicine, the TGA evaluates the application through the standard pathway or one of its other pathways, such as priority review, provisional approval, or the comparable overseas regulator pathway, which can draw on an approval from a trusted regulator like FDA or EMA.

Question 5

What is the Australian eCTD Module 1?

Accepted Answer

Australia uses its own regional Module 1 for administrative and product information, set out in the TGA's Australian Module 1 specification, while Modules 2 to 5 follow the ICH Common Technical Document (CTD) structure. The TGA updates the specification over time, so check the current version and its mandatory dates on the TGA website.

Question 6

How does TGA approval compare to FDA's?

Accepted Answer

In broad terms it follows the same two stages: clinical trials first, then an application to register the product. Where FDA approves an NDA or BLA, TGA registers a prescription medicine on the ARTG after evaluating the application. Timelines, data requirements, and local steps differ, so confirm the current requirements for your product with TGA guidance or an Australian regulatory partner.

Question 7

How do clinical trials work with TGA compared to an FDA IND?

Accepted Answer

Australia has two schemes. Under the Clinical Trial Notification (CTN) scheme, the sponsor notifies TGA and the trial is reviewed by a human research ethics committee. Under the Clinical Trial Approval (CTA) scheme, TGA evaluates the trial before it starts. An FDA IND, by comparison, lets a trial generally proceed 30 days after submission unless FDA places it on clinical hold.

Question 8

Can we manage TGA, FDA, Health Canada, and EMA submissions in one place?

Accepted Answer

Yes. Your Australian submission sits in the same Assyro workspace as your FDA, Health Canada, and EMA submissions for the same program, so one team sees every filing.

Question 9

Does Assyro decide what we file with TGA?

Accepted Answer

No. AI drafts, checks, and triages the work. Your regulatory professionals review it and decide what is submitted to TGA.

Question 10

How do we start a TGA submission with Assyro?

Accepted Answer

Book a demo with your program details: the product, the submission type, and your target filing date. We walk through how Assyro handles your Australian submission.

TGA Registration and eCTD Submissions for Australia

TGA Filing Workflow

Australia in the Same Workspace

Clear Owners for Every Australian Task

Status Without the Rebuild

Decisions You Can Find Again

TGA Filing Controls and Capacity

Maintain Audit-Ready TGA Records

Manage More TGA Programs With the Same Team Size

Guides for your next decision

Questions About TGA Submission Software

See Your Australian Submission in Assyro.