The TGA Special Access Pathway

The Special Access Scheme (SAS) is an Australian regulatory pathway that allows qualified doctors to access unapproved therapeutic goods (including unapproved peptides) for individual patients with serious conditions when approved alternatives are unavailable or unsuitable.

SAS is not a blanket approval; each application is assessed individually for a specific patient.

A patient must have a serious condition or life-threatening illness. Approved alternative treatments must be unavailable or unsuitable. A registered medical practitioner (with appropriate qualifications) must apply and provide clinical justification. The proposed unapproved peptide must be therapeutically relevant.

SAS is not for cosmetic or enhancement purposes.

A doctor submits an application to the TGA with: patient details (de-identified), diagnosis and clinical justification, rationale for why approved options are unsuitable, details of the unapproved peptide, proposed dose and monitoring plan. The TGA assesses the application and grants approval or requests more information.

Some applications are approved rapidly; others require back-and-forth discussion.

SAS approval is patient-specific; a doctor must apply separately for each patient. The approved peptide may have restrictions on sourcing, duration of use, or monitoring requirements. SAS is not a path to unlimited access; it is for individual medical necessity.

Supply may be from a compounding pharmacy or through other regulated channels.

SAS is a clinical access pathway, not a research pathway. Using SAS approval to obtain research peptides for non-medical purposes is not permitted and may constitute fraud.