Usage Examples
- We cannot ship to Australia until the ARTG entry is live, and TGA has not closed out the evaluation.
- That product goes in under Chapter 4, so it is a TGA inclusion, not a registration.
- Access Consortium work-sharing saved us a duplicate assessment, but TGA still issued its own decision.
What is TGA (Therapeutic Goods Administration)?
TGA is Australia's national regulator of therapeutic goods, applying the Therapeutic Goods Act 1989 to decide which medicines, biologicals and medical devices may enter the Australian Register of Therapeutic Goods and be supplied lawfully.
TGA exists because Australia decided that no medicine, biological or medical device should reach a patient on a sponsor's own assurance. The Therapeutic Goods Act 1989 makes market access a statutory permission rather than a commercial decision: goods enter the Australian Register of Therapeutic Goods first, and criminal offences and civil penalties sit behind that gate.
TGA covers prescription and over-the-counter medicines, complementary medicines, biologicals and medical devices, and its statutory vocabulary differs by product type: medicines and most other goods are registered or listed, while medical devices are included in the Register under Chapter 4 of the Act. TGA regulates the goods themselves, not how a prescriber uses them once supplied.
TGA is applied in practice through the sponsor: the entity that holds the ARTG entry and carries the conditions of registration or listing that section 28 of the Act attaches to it. Regulatory teams therefore plan the Australian dossier around the entry they want, because the ARTG record, not the submission, defines what may lawfully be supplied.
Not to be confused with
- ARTG
- the ARTG is the statutory register maintained under section 9A; the TGA is the regulator that decides what goes on it. Nothing is "TGA approved" in the abstract. A product holds a specific ARTG entry, and the entry is the scope of the approval.
- Access Consortium
- a five-regulator work-sharing coalition the TGA belongs to alongside the MHRA, Health Canada, the Health Sciences Authority of Singapore and Swissmedic. It shares assessment effort; it does not issue approvals. Each member still makes its own national decision.
- Health Canada and MHRA
- national regulators with the equivalent function in their own jurisdictions. An approval from one creates no ARTG entry. Reliance can shorten the assessment, but Australian supply still requires the good to be on the Australian Register.
- Registration versus inclusion
- for medicines the Act speaks of registration or listing; for medical devices it speaks of inclusion in the Register under Chapter 4. Using the wrong verb usually means the project has been scoped under the wrong regime.
These are the obligations that determine whether a product can lawfully reach an Australian patient.
What you must do
- 1Enter the good in the Australian Register of Therapeutic Goods, the register the Act establishes and from which entries can also be varied or removedTherapeutic Goods Act 1989 s 9A
- 2Do not import, export, manufacture or supply therapeutic goods in Australia without the required registration or listing, since criminal offences attach to doing soTherapeutic Goods Act 1989 s 19B
- 3Meet and keep meeting the conditions attached to the registration or listing for the life of the entry, not only at the point of approvalTherapeutic Goods Act 1989 s 28
- 4For a medical device, have the kind of device included in the Register under the separate device regime before supplying itTherapeutic Goods Act 1989 s 41FF
Common mistakes
Assuming an FDA or EMA approval carries into Australia
it does not. Access Consortium work-sharing can reuse assessment effort across its five members, and the FDA is not one of them. Even inside the consortium each regulator issues its own decision, and supply in Australia still requires an ARTG entry.
Treating "TGA approved" as a company-level or product-family status
approval attaches to one ARTG entry with a defined indication, presentation and set of conditions under section 28. Promoting or shipping a variant outside that entry is supplying an unentered good, with the offence and civil penalty provisions in play.
Running a device project on a medicines plan
devices are included in the Register under section 41FF and move through conformity assessment certificates, not a medicines evaluation dossier. Teams that copy the medicines timeline discover the conformity assessment step late and lose months of Australian revenue.
When This Matters
- We cannot ship to Australia until the ARTG entry is live, and TGA has not closed out the evaluation.
- That product goes in under Chapter 4, so it is a TGA inclusion, not a registration.
- Access Consortium work-sharing saved us a duplicate assessment, but TGA still issued its own decision.
Frequently Asked Questions
TGA approval means the product has an entry in the Australian Register of Therapeutic Goods, the register established by section 9A of the Therapeutic Goods Act 1989. The entry, not the company, is approved: it fixes the indication, presentation and the conditions of registration or listing that apply under section 28.
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