How the TGA regulates CBD

The Therapeutic Goods Administration (TGA) treats CBD as a medicine. It decides which schedule CBD sits in, approves or declines medicines for the national register, runs the pathways that let prescribers use unapproved products, sets the quality standard, and enforces the ban on advertising. What it has not done, for nearly all CBD products, is assess whether they are safe or work.¹

What is the TGA?

The TGA is the part of the Australian Government health department that regulates medicines and medical devices. A medicine it has assessed and approved is entered on the Australian Register of Therapeutic Goods (ARTG). Such a medicine is called “registered” or “approved”.

Which CBD medicines are approved?

As of the latest official statements we found (Ahpra guidance reviewed in September 2026), two cannabis medicines are registered.² They are Epidyolex, a CBD medicine for seizures in two rare epilepsy syndromes, and Sativex, a spray containing both THC and CBD for spasticity in multiple sclerosis. See the registered cannabis medicines.

No low-dose, pharmacist-only CBD product has been registered. See over-the-counter CBD.

What does “unapproved” mean?

The TGA puts it this way: “Most medicinal cannabis products in Australia are unapproved therapeutic goods, meaning they are not included in the Australian Register of Therapeutic Goods (ARTG) and have not been assessed by us for safety, quality or effectiveness.”¹

Unapproved does not mean illegal. It means the TGA has not done its usual assessment of the product, and the prescriber takes on more responsibility. According to the TGA, more than 1,000 unapproved medicinal cannabis products have been supplied, and over 99% of the products prescribed are unapproved.³

How do unapproved products reach patients?

There are three routes: the Special Access Scheme (which has two categories), the Authorised Prescriber scheme and clinical trials. All of them run through a health practitioner.⁴

The descriptions above are summarised from the TGA.¹ Patients cannot apply themselves. Access “can only be arranged through an Australian registered health practitioner”.¹

The TGA says doctors and nurse practitioners may use these pathways “if all other clinically appropriate treatment options on the ARTG have been considered”.¹ The TGA has confirmed that since 2021, applications are made by category of active ingredient and not by brand.³

Use of the pathways has grown quickly. Special Access Scheme Category B approvals for medicinal cannabis rose from 57,711 in 2020 to 177,762 in 2024.³ Most of these were not for CBD-only products. See the Special Access Scheme and the Authorised Prescriber scheme.

How does the TGA classify products?

The TGA groups medicinal cannabis products into five categories by how much of the cannabinoid content is CBD.⁵

The TGA describes Categories 2 to 5 as Schedule 8.⁴ Only Category 1 is CBD-only in the legal sense. A Category 2 “CBD-dominant” oil is a Schedule 8 controlled drug and may contain meaningful THC. The TGA also notes the categories “were not intended to differentiate products based on their relative psychoactivity or THC content”.³ See CBD scheduling explained.

What rules apply to unapproved products?

Quality. All medicinal cannabis supplied in Australia must meet a standard known as TGO 93, which covers cannabinoid content, pesticides, microbes and other contaminants.³ The TGA does not test every product. It uses risk-based surveillance testing.³ See quality standards.

Supply chain. Companies must keep unregistered medicinal cannabis under their “direct control” until it is supplied under one of the pathways. Wholesaling unregistered finished products is prohibited.⁶

Prescriber duties. Prescribers must obtain and record informed consent, tell patients the product is unapproved and may affect driving, and report adverse events (harmful reactions) to the TGA within 15 calendar days.⁷

Advertising. Advertising medicinal cannabis to the public is prohibited.⁸ See why clinics cannot advertise CBD.

Importing. Imports are controlled by a separate body, the Office of Drug Control, and need a licence and a permit.⁹ See importing CBD.

Who else regulates CBD?

• Ahpra and the National Boards regulate the practitioners. In July 2025 they published guidance on medicinal cannabis prescribing, after finding that eight practitioners had each issued more than 10,000 scripts in six months.¹⁰ The guidance says medicinal cannabis is “never a first line treatment” and that prescribing needs a real-time consultation.²
• State and territory health departments apply the schedules through their own medicines laws and may add prescribing requirements.¹¹
• The Pharmaceutical Benefits Advisory Committee decides which medicines are subsidised. See PBS, Medicare and health insurance.

What is the TGA review, and what might change?

From 11 August to 7 October 2025 the TGA ran a public consultation called “Reviewing the safety and regulatory oversight of unapproved medicinal cannabis products”.¹² It received close to 800 submissions. TGA documents give the figure as 790 in one place and 786 in another.¹³¹⁴

The headline finding was that stakeholders agreed the current framework is “not fit-for-purpose and not proportionate to the potential safety and quality risks”.¹² On CBD specifically, most stakeholders viewed it as “generally well tolerated” with a better safety profile than THC, while noting adverse events, drug interactions and a shortage of high-quality data.¹²

The TGA reported 1,101 adverse event cases for medicinal cannabis from 2016 to 31 July 2025, of which 24% were serious.³ It also told its scheduling committee in March 2026: “To date a safety signal has not been flagged for any unapproved medicinal cannabis product”.¹³

Ideas raised in the review include limits on THC concentration, plain packaging, child-resistant closures, restrictions on gummies and separate schedule entries for other cannabinoids. None has been adopted.¹³

The TGA has set out staged next steps. In the short term, public awareness. In the medium term, to “consider current scheduling arrangements, reviewing quality requirements”. In the long term, reform options for government to decide.¹⁴ Medicinal cannabis is also a named TGA compliance priority for 1 January 2026 to 31 December 2027.¹⁴

As of the latest TGA documents we could find (mid-2026), no reform has been decided.¹⁴ We could not confirm whether anything further was announced between July and November 2026.

This page is general information, not medical or legal advice. Laws and evidence change; we show the date we last checked the facts at the top of every page. Talk to your doctor or pharmacist before starting, stopping or changing any medicine.

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