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Scientific interest, trial access, Australian medicine registration and PBS subsidy are different questions. A compound may be under investigation without an approved product for routine supply. An overseas decision does not become an Australian decision. This guide shows where to check each claim and how to describe what the public record actually says.
Editorial review: 7 October 2026. Regulatory material is time-sensitive; use the linked authority record for current status. This is general information, not legal or medical advice.
Current Australian answer desk
Start with the question you are actually trying to answer. Each guide below uses the relevant authority record and keeps approval, subsidy, testing and trial evidence separate.
GLP-1 medicines and PBS
Ozempic, Wegovy, Mounjaro and other marketed medicines by indication, PBAC stage and live PBS status.
Retatrutide trial status
Peer-reviewed Phase 3 results, active programme records and why publication is not approval.
TGA, ARTG, PBAC or PBS?
A plain-language map of the four systems most often confused in Australian searches.
Lab test or regulatory approval?
What CoAs, HPLC, mass spectrometry, GMP evidence and ARTG inclusion each prove—and do not prove.
The Australian status map
| Question | Check this record | What the answer means |
|---|---|---|
| Is a particular medicine registered or listed for supply? | Search the ARTG through the TGA by product name, active ingredient or sponsor. | Inspect the actual product entry, indication and sponsor. A similar molecule name on a website is not that entry. |
| Can an unapproved good be studied in Australia? | TGA clinical-trial pathways, including CTN and CTA. | A lawful research pathway has its own controls; it does not mean routine public approval. |
| Is there an Australian safety alert? | TGA safety alerts and the linked primary notice. | Read the event date, tested material and scope. A finding from one tested sample is not automatically a finding about every product. |
| Is a medicine subsidised? | Pharmaceutical Benefits Scheme and the specific listing. | PBS funding is a separate decision. An ARTG entry alone does not establish a PBS listing. |
| What is its scheduling? | The current Australian Poisons Standard and TGA scheduling guidance. | Scheduling controls access and handling; it does not itself demonstrate clinical benefit or ARTG approval. |
How to check a claim in three minutes
- Name the exact thing: molecule, finished product, brand, sponsor and claimed indication. These are not interchangeable.
- Name the jurisdiction: Australia, the United States and other countries can reach different decisions at different times.
- Open the authority record: use the ARTG entry, TGA notice or PBS listing itself. Record the publication or effective date and the date you checked it.
- Separate the routes: a registered clinical trial, an exceptional access pathway, a scheduling category and routine marketing approval each answer a different question.
- Read the exact wording: a statement that research is underway is not an approval; a “research use only” label is not an exemption from therapeutic-goods rules.
A current case study: retatrutide
On 14 September 2026, the TGA reported testing a product sold as retatrutide after a serious adverse-event report. The tested unmarked vial contained undeclared semaglutide and no retatrutide. The regulator said retatrutide was still in human clinical trials and had not been approved by the TGA or a comparable international regulator. These are the authority’s findings about a specific sample and the status stated in that notice; they are not a claim that every online product has the same contents.
Our alert briefing explains exactly what was tested. Our GLP-1 medicines in Australia guide separates TGA-approved indications, PBAC recommendations and current PBS listings. The trial tracker now separates peer-reviewed Phase 2 and TRIUMPH-1 Phase 3 results from sponsor summaries, registries and regulatory decisions. The GLP-3 guide corrects a popular nickname without confusing a receptor mechanism with approval.
Is retatrutide named in the October 2026 Poisons Standard?
No individual entry for “retatrutide” was found in our 20 October 2026 text search of instrument F2026L01327. That is a search result, not a legal determination. The instrument’s reader’s guide explains group entries and derivatives; an individual-name search cannot resolve those questions. Scheduling also does not confer ARTG approval.
The TGA’s peptide-products guidance addresses unapproved therapeutic goods separately. A trial programme, laboratory result or overseas publication does not create general Australian approval.
New NSW surveillance briefing
Our NSW emergency-department surveillance analysis explains the new reported-use signal and why a triage mention, chemically verified exposure and causal finding are different kinds of evidence.
Current enforcement example: Melanotan II
On 21 May 2026, the TGA announced 27 paid infringement notices totalling A$101,412 over the alleged unlawful supply of Melanotan II. The regulator stated that Melanotan II is prescription-only, is not approved for sale or use as a tanning agent, and that no products containing it were on the ARTG or approved for supply in Australia. The October 2026 Poisons Standard lists Melanotan II in Schedule 4.
Our Melanotan II Australia evidence profile examines the small human tanning studies, the difference between a safety signal and proof of melanoma causation, serious toxicity case reports and why a laboratory purity claim cannot substitute for product approval. Read the TGA enforcement notice for the authority record.
NAD and NMN: current listed-medicine rules
The TGA’s NAD/NMN information, updated on 3 February 2026, states that NAD, NAD+ and NADH are not permitted ingredients in listed medicines. NMN can be used in a listed medicine only when all current sponsor, ingredient, route, indication and other conditions are met. An AUST L entry permits only the product and low-level indications in that record; it does not establish that NAD-related products reverse ageing or that an IV service has demonstrated clinical benefit.
On 12 August 2026, the TGA published detailed guidance on how NAD- and NMN-related representations can breach advertising and presentation rules. Read the TGA consumer and sponsor notice, the advertising guidance and our NAD+ Australia human-evidence profile.
Common claims that need a second look
- “It is in Phase 3, so it is approved.” Phase 3 describes development. Approval requires a separate regulatory decision for a defined product and use.
- “The FDA approved it, so it is legal here.” Verify both the overseas claim and the Australian ARTG record. Overseas status cannot substitute for an Australian decision.
- “The molecule is scheduled, so any vial with its name is genuine.” Scheduling says nothing about the identity, strength or sterility of that vial.
- “It is not on the PBS, so it must be unapproved.” Registration and subsidy are separate; check both systems.
- “Research use only makes it safe or lawful for personal use.” A marketing label cannot establish product quality, regulatory status or clinical safety. See the TGA’s public advertising guidance.
New TGA peptide-products guidance
On 23 September 2026, the TGA published a consolidated peptide-products information hub covering regulation, online-product risks, practitioner responsibilities and reporting. It states that some peptide medicines are approved, while many products promoted online are unapproved and may be unlawful to import, supply or advertise.
A laboratory result and a regulatory decision answer different questions. Our new peptide lab tests versus TGA approval guide shows how a CoA, independent test, TGA sample result, GMP evidence, ARTG entry and unapproved-goods pathway differ—and why a “pass” is not blanket approval.
Read further
Start with our guide to ARTG, unapproved goods and trials. Then use the Research Library for molecule-specific evidence and the Clinical Trials hub for the distinction between registration, toplines and full results. To report a factual error or a changed authority notice, contact the editorial team; see our corrections process.
Boundary: We explain public records. We do not provide legal advice, prescribing advice, purchasing routes, dosing or instructions for human use.