How a Medicine Joins the ARTG

Roughly 600 prescription medicines are added to or varied on the Australian Register of Therapeutic Goods each year. Cannabis-derived medicines have been chasing that number since 2016, and the gap between "approved overseas" and "registered here" remains surprisingly wide. I get asked about this constantly , usually by people who've just discovered that a medicine available in Canada or the UK isn't listed here, and want to understand why.

The short version is that registration is a quality, safety, and efficacy hurdle, not a customs one. Let's walk through what that actually means in practice.

What the ARTG is, and what it isn't

The Australian Register of Therapeutic Goods (ARTG) is a public database maintained by the Therapeutic Goods Administration. Every medicine, medical device, or biological product that is legally supplied in Australia must either appear on the ARTG or qualify for an explicit exemption. There is no third option.

Being on the register doesn't mean a medicine is available at your local pharmacy. It means the TGA has evaluated , to a defined standard , the evidence submitted by a sponsor and concluded the product meets requirements for quality, safety, and efficacy. The registration is then linked to a sponsor (usually the company that applied), a specific formulation, specific indications, and specific labelling. Change any of those materially, and you're looking at a new or varied entry.

For cannabis-derived medicines specifically, scheduling under the Poisons Standard (the document formally known as the Standard for the Uniform Scheduling of Medicines and Poisons, or SUSMP) runs alongside ARTG status. A product can be ARTG-registered and still require a Schedule 8 controlled drug prescription, which is what applies to most THC-containing medicines. Cannabidiol products meeting the low-dose criteria under Schedule 3 occupy a different lane; but even those went through a formal TGA scheduling process before any pharmacist could hand one over the counter.

The three registration pathways

The TGA runs two main evaluation pathways for prescription medicines, plus a separate route for listed (lower-risk) products. Understanding which lane a cannabis medicine falls into determines almost everything about cost, timeline, and evidence requirements.

Registered medicines, the full evaluation route. This is the pathway for higher-risk products, including all controlled substances and most prescription-only items. The sponsor lodges a dossier, think of it as an evidence package, often running to tens of thousands of pages; covering chemistry and manufacturing data, pre-clinical toxicology, and human clinical trial results. The TGA's evaluation team works through that dossier, typically over 12 to 18 months for a standard application. The sponsor pays an evaluation fee; as of the 2024–25 fee schedule these run into six figures for a full Category 1 application.

For a cannabis-derived medicine to reach registered status via this route, the sponsor must also demonstrate Good Manufacturing Practice (GMP) compliance, at every site in the supply chain that touches the medicine. That includes overseas cultivation and extraction facilities. The TGA may accept GMP clearances issued by comparable overseas regulators, but it isn't automatic.

Listed medicines, the lower-risk route. Listed products (ARTG entries beginning with "AUST L") are generally complementary medicines making only low-level claims. The sponsor self-certifies compliance against a list of permitted ingredients and indications; the TGA audits rather than pre-evaluates. Very few cannabis products qualify here, because cannabinoids are not currently on the permitted ingredients list for listed medicines with any meaningful indication.

Biosimilars and generic pathways. A generic applicant can reference an already-registered "innovator" product's clinical data and submit an abridged dossier, relying on demonstrated bioequivalence rather than full trial programs. This matters for cannabis because if one full-spectrum oral product is registered for a given indication, a later applicant with a comparable formulation may be able to follow an abridged route; though the pharmacokinetics of cannabis extracts are notoriously variable, and proving bioequivalence is genuinely difficult. Bioavailability data across different oral formulations, inhalation products, and the like can diverge considerably.

What the evidence dossier must cover

The TGA follows the Common Technical Document (CTD) format, the same international template used by regulators in the EU, US, Canada, and Japan. Module 3 covers quality (chemistry, manufacturing, controls). Module 4 covers non-clinical (laboratory and animal) data. Module 5 covers clinical data.

For any medicine containing THC or other controlled cannabinoids, Module 3 carries extra weight. The TGA will want to see detailed characterisation of the extract, not just the primary cannabinoid but the full profile, including minor constituents. If a product is marketed as full-spectrum, the composition needs to be defined and controlled batch-to-batch. That's harder than it sounds when you're working with a botanical extract; natural variation is real, and the analytical chemistry has to account for it.

Module 5; the clinical evidence, is where most applications for novel cannabis medicines hit friction. The TGA requires adequate and well-controlled clinical trials demonstrating efficacy for the proposed indication. Observational data, case series, and compassionate-use reports are supportive at best; they don't substitute for randomised controlled trial evidence. This is worth saying plainly because there's a persistent belief in some quarters that the TGA is simply being obstructionist about cannabis. I'd argue that's not quite right: the agency is applying the same evidentiary standard it applies to every other medicine, and that standard is demanding by design.

After registration: scheduling, PBS, and what "approved" really means

ARTG registration and PBS listing are separate decisions made by separate bodies. A medicine can be registered, meaning the TGA is satisfied with quality, safety, and efficacy evidence; and still not be subsidised under the Pharmaceutical Benefits Scheme. The Pharmaceutical Benefits Advisory Committee (PBAC) conducts its own cost-effectiveness assessment, and the minister makes the final call on PBS listing. For patients paying out of pocket, ARTG-registered cannabis medicines carry price tags that vary widely by formulation and dose.

Scheduling determines who can prescribe or supply the medicine and under what conditions. Most THC-containing registered products sit at Schedule 8, which means controlled drug prescription rules apply, state and territory permit requirements, prescription limits, and dispensing record-keeping. Schedule 4 applies to most CBD-dominant registered medicines above the low-dose threshold.

For medicines not yet registered, the Special Access Scheme and the Authorised Prescriber pathway exist as lawful routes to access unapproved therapeutic goods, but that's a separate article, and the mechanics are quite different from what I've described here.

Why registration matters beyond the paperwork

I spent a chunk of last Tuesday evening down a rabbit hole of historical TGA consultation documents; not everyone's idea of a relaxing night, I'll admit, but vintage survey maps were drying so there wasn't much choice. What struck me, rereading the 2016 cannabinoid scheduling amendments, was how much the framework anticipated the supply-chain complexity that later played out. The requirement for GMP-compliant manufacturing wasn't an afterthought; it was the hinge on which the whole access model turned.

That complexity matters to patients and prescribers in a practical way. An ARTG-registered product comes with a defined, tested formulation. The standardised extract on the label reflects what's in the bottle, with a documented tolerance. Batch records exist. Post-market surveillance obligations attach to the sponsor. None of that is guaranteed for a product accessed outside the registration framework, and the TGA has been increasingly active in enforcement action on that front.

The register, for all its administrative weight, is doing real work. Getting a medicine onto it is genuinely hard. But that hardness is, mostly, the point.

Sources

• Australian Register of Therapeutic Goods (ARTG), Therapeutic Goods Administration (TGA)
• Guidance on the registration of prescription medicines, TGA
• Poisons Standard (SUSMP); Federal Register of Legislation, Australian Government
• Medicinal cannabis, Therapeutic Goods Administration (TGA)

, Marcus Hale, Regulatory researcher, TGA & access law

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