Executive summary
Australia and New Zealand have separate regulators — the TGA (Australia) and Medsafe (New Zealand) — with distinct legislative frameworks. Both require marketing authorisation for peptide drugs. Both offer pathways for access to unapproved medicines through special access schemes and personal importation. Compounding is permitted within strict boundaries.
- Australia: TGA, then ARTG, a clinical-trial or access route, or compounding and supply rules.
- New Zealand: Medsafe, then consent to distribute, a clinical or import pathway, or pharmacy rules.
- There is no automatic transfer of status between the countries.
Side-by-side comparison
| Question | Australia | New Zealand | Source link |
|---|---|---|---|
| Primary authority | TGA administers the Therapeutic Goods Act 1989 | Medsafe administers the Medicines Act 1981 and Medicines Regulations 1984 | Therapeutic Goods Act and Medsafe |
| Authorization record | ARTG entry is generally required unless an exemption, exclusion, or statutory pathway applies | Medsafe consent to distribute is product-specific | ARTG and Medsafe Product Search |
| A clinical-stage candidate with scientific or public relevance. Investigation is not approval, and a studied exposure is not a recommendation. Fuente de la definición: Scope and selection methodology · Glosario pathway | CTN or CTX notification or approval route | No specific New Zealand study route is summarized on this page; verify the current national record | Country sections; current regulator records remain decisive |
| Compounding | Individual-patient prescription exemption within the stated scale boundary | Named-patient pharmacy compounding under section 25; manufacturing licence beyond extemporaneous scale | TGA compounding and the New Zealand country section |
| Personal import | A conditional Personal Importation Scheme, separate from approval | A conditional personal-import route, separate from consent to distribute | TGA personal importation and Medsafe personal import |
| Research-use-only classification | Wording alone is not dispositive; intended use, presentation, claims, and supply facts matter | Research wording is not a safe harbour when therapeutic claims make the product a medicine | The country sections and current national laws |
Australia
Authorities and legal categories
TGA (Therapeutic Goods Administration): regulation under the Therapeutic Goods Act 1989 (Cth).
ARTG (Australian Register of Therapeutic Goods): therapeutic goods must generally be registered or listed unless exempt, excluded, or supplied under an applicable statutory pathway.
ACMS (Advisory Committee on Medicines Scheduling): prepares the Poisons Standard (SUSMP).
Key instruments:
Therapeutic Goods Act 1989 (Cth).
Poisons Standard (SUSMP).
Therapeutic Goods Advertising Code (No. 2).
Approved medicines
Peptide medicines registered on the ARTG include insulin analogues, GLP-1 receptor agonists (semaglutide, liraglutide, tirzepatide, dulaglutide, exenatide), teriparatide, octreotide, leuprolide, goserelin, desmopressin, and calcitonin. Most are Schedule 4 (Prescription Only) under the SUSMP.
Source: https://www.tga.gov.au/resources/artg
A clinical-stage candidate with scientific or public relevance. Investigation is not approval, and a studied exposure is not a recommendation. Fuente de la definición: Scope and selection methodology · Glosario use
Clinical trials require TGA notification or approval under the Clinical Trial Notification (CTN) or Clinical Trial Exemption (CTX) schemes.
Compounding/manufacturing
Extemporaneous compounding for an individual patient on prescription is exempt from ARTG entry under s. 18 of the Act, provided it is not conducted on a scale that makes it "like a manufacturer." The TGA's Compounding of Medicines: A Guide outlines the boundary.
Source: https://www.tga.gov.au/compounding
Import, sale, advertising, and online supply
Personal Importation Scheme: individuals may import up to 3 months' supply of an unapproved therapeutic good for personal use. The goods must be for the individual's own treatment or for a member of their immediate family, and a prescription from an Australian-registered doctor is required for prescription-only medicines. Routine TGA notification is not required for personal importation under this scheme.
Special Access Scheme (SAS): Categories A, B, C — for individual patients with medical need. Category B requires TGA notification/approval.
Authorised Prescriber Scheme: practitioners can apply to prescribe unapproved medicines to a class of patients.
Advertising: Prescription medicines (Schedule 4/8) cannot be advertised to the public. The Therapeutic Goods Advertising Code enforces against peptide vendors using social media or e-commerce platforms.
Sources:
Research-use-only products
A genuine laboratory reagent may fall outside therapeutic-goods regulation depending on intended use, presentation, claims, and supply facts; RUO wording alone is not dispositive. TGA has warned that "not for human consumption" labelling does not shield products marketed with therapeutic claims.
Enforcement examples and uncertainty
TGA has taken action against peptide suppliers marketing via social media and making human-use claims behind "not for human consumption" labels.
New Zealand
Authorities and legal categories
Medsafe (Ministry of Health): administers the Medicines Act 1981 and Medicines Regulations 1984.
Key instruments:
Medicines Act 1981.
Medicines Regulations 1984.
Approved medicines
Peptide medicines with Medsafe consent to distribute include GLP-1 receptor agonists, insulins, growth hormone, and other peptide therapeutics.
Source: Medsafe Product Search, https://www.medsafe.govt.nz/DbSearch/
A clinical-stage candidate with scientific or public relevance. Investigation is not approval, and a studied exposure is not a recommendation. Fuente de la definición: Scope and selection methodology · Glosario use
No specific New Zealand clinical-study pathway is summarized in this page's source material; a current Medsafe or Ministry of Health record is required before drawing a route-specific conclusion.
Compounding/manufacturing
Pharmacy compounding is permitted under s. 25 of the Medicines Act for a named patient. Beyond extemporaneous scale, a manufacturing licence is required under the GMP Code.
Import, sale, advertising, and online supply
Personal import: up to 3 months' supply for prescription medicines, requiring a letter from a New Zealand-registered prescriber. Must be declared on arrival.
Importers under s. 25 can directly import for a named patient.
Source: https://www.medsafe.govt.nz/Consumers/MIET/ImportMedicines.asp
Research-use-only products
Similar to Australia: "research only" labelling is not a safe harbour. Therapeutic claims make the product a medicine requiring consent.
Practical interpretation limits
This is general regulatory research, not legal advice. Classification can turn on composition, claims, intended use, route, supplier role, and facts not captured by a product name.
Related atlas pages: global framework, cross-border supply, WADA and sport, and approved-product label index.
Primary sources
Therapeutic Goods Act 1989 (Cth). https://www.legislation.gov.au/C2004A03952/latest/text
TGA Compounding Hub. https://www.tga.gov.au/compounding
TGA Personal Import. https://www.tga.gov.au/personal-importation-scheme
ARTG Search. https://www.tga.gov.au/resources/artg
Medsafe. https://www.medsafe.govt.nz
Medicines Act 1981 (NZ). http://www.legislation.govt.nz/act/public/1981/0118/latest/DLM53790.html
Medsafe Personal Import. https://www.medsafe.govt.nz/Consumers/MIET/ImportMedicines.asp