Australia
AUOceania
Regulatory Overview
Australia is regulated by the TGA (Therapeutic Goods Administration). The country has 2 documented regulatory pathways for accessing unapproved or unlicensed medicines, covering named patient programs, compassionate use schemes, and special access arrangements.
Regulatory Authority
TGA (Therapeutic Goods Administration)
Regulatory Pathways (2)
Allows medical practitioners to supply unapproved therapeutic goods to a class of patients with a particular medical condition without requiring individual TGA approvals for each patient.
Application Form: TGA Authorised Prescriber Application
Legal Basis: Therapeutic Goods Act 1989 Section 19
Eligibility: Serious or life-threatening condition with no locally registered alternative
Reference: TGA Authorised Prescriber Guidance
TGA SAS Category B allows supply of unapproved therapeutic goods to individual patients on a case-by-case basis, with TGA approval required before supply.
Application Form: TGA SAS-B Notification/Approval Form
Legal Basis: Therapeutic Goods Act 1989 Section 19
Eligibility: Serious or life-threatening condition with no locally registered alternative
Reference: TGA SAS Guidelines
Drugs Available (186)
Australia
| ISO Code | AU |
| Region | Oceania |
| Regulatory Authority | TGA (Therapeutic Goods Administration) |
| Pathways | 2 documented |
| Drugs Available | 186 drug(s) |