Special Access Scheme (SAS)

The Special Access Scheme (SAS) is the pathway the Therapeutic Goods Administration (TGA) uses to let a registered Australian health practitioner lawfully access and supply an ‘unapproved’ therapeutic good — a medicine, medical device, or biological not entered on the Australian Register of Therapeutic Goods (ARTG) for the use in question — to a specific patient, or a defined group of patients, outside a formal clinical trial. It operates under the Therapeutic Goods Act 1989 (Cth) and is administered through the SAS and AP Online System.

For a research administrator, SAS matters because it sits directly adjacent to, but is legally and procedurally distinct from, the two pathways that govern supply of an unapproved good inside a trial — the CTN and CTA schemes. A research office that only tracks CTN/CTA can miss the moment a product needs to move onto SAS: most commonly when a trial closes to enrollment or a participant’s involvement ends, but a treating clinician wants to keep supplying the same still-unapproved product because the patient is still benefiting from it.

The three SAS categories

SAS has three access pathways, distinguished by urgency and by how much evidence already exists for the product:

• Category A — a notification-only pathway for patients who are seriously ill. The practitioner can use the product immediately and must notify the TGA within 28 days of supply. No prior TGA sign-off is required.
• Category B — an application-based pathway for patients who do not meet Category A or C criteria. The practitioner submits an application and must wait for TGA approval before supplying the product; approval typically takes 2 to 5 working days.
• Category C — a notification-only pathway limited to products on a specific TGA-published list of goods with an established history of safe use. The practitioner can start supply immediately and notifies the TGA afterward.

All three categories require the practitioner to have first considered any ARTG-listed alternative, to follow good medical practice (including informed consent), and to report adverse events to the TGA.

SAS vs. the Authorised Prescriber (AP) scheme

SAS and AP both authorise supply of an unapproved good outside a trial, and practitioners sometimes confuse the two. The distinction is about scope and duration, not the product itself: SAS is scoped to an individual patient or a specific, defined group, assessed per request; AP is limited to medical practitioners and is designed for repeat prescribing to an open-ended class of patients over time, without a fresh SAS request for each one. A hospital anticipating ongoing need for the same unapproved product across many future patients typically moves toward an AP application rather than filing repeated individual SAS requests.

Why this is a research-office issue, not just a prescribing one

SAS requests involving a product that was previously under an active clinical trial are not purely a clinical decision — they carry the same product-history, sponsor-relationship, and supply-chain considerations the research office already manages under CTN/CTA. Confirming ARTG status, checking whether the sponsor is still willing and able to supply the product, and documenting the shift from trial-governed supply to SAS-governed supply are exactly the kind of continuity questions a clinical trials or research governance office is positioned to catch that an individual treating clinician, acting alone, may not think to raise. This is functionally the same problem CASRAI’s guide to FDA compassionate use and expanded access describes for the U.S. system: a named-patient access mechanism that sits adjacent to, but outside, the formal trial-authorisation pathway, requiring its own separate compliance judgment once a patient’s route to a still-unapproved product stops running through the trial itself.

Example

A phase II oncology trial closes to new enrollment. Two participants who responded well to the investigational drug have no comparable approved alternative. Rather than extending the trial protocol — which would require HREC and CTN/CTA amendment — the treating oncologist and the sponsor arrange continued supply through SAS Category B, since the patients are seriously ill but the situation allows time for the standard TGA approval turnaround. The research office tracks this as a distinct, non-trial supply arrangement, separate from the now-closed trial’s own TGA notification.

Counter-example

A sponsor is preparing to supply an investigational drug to newly enrolled participants in a trial that has just received HREC approval and is about to lodge its TGA notification. This is a CTN/CTA matter, not SAS — SAS only covers access outside a clinical trial. Filing an SAS application for participants who are about to be formally enrolled in a notified or approved trial is the wrong pathway and would not satisfy the trial’s own regulatory requirements.

Related terms

• TGA CTN and CTA Schemes — the pathways governing supply of an unapproved good used IN a clinical trial, as distinct from SAS’s outside-a-trial, individual-patient scope.
• HREC (Human Research Ethics Committee) — the ethics-review body relevant to the trial an SAS request may follow on from, though SAS itself does not require HREC approval.
• Compassionate Use and Expanded Access (FDA) — the closest US functional analogue: a named-patient access mechanism for an unapproved product outside a formal trial.

Verified against the SAS and AP Online System’s own description of the two schemes (compliance.health.gov.au) and corroborated by TGA’s published guidance on SAS categories and the Australian Government Department of Health’s Special Access Scheme overview page; a direct fetch of tga.gov.au itself failed to connect during this session (consistent with prior sessions’ notes on tga.gov.au fetch reliability), so category timeframes are corroborated across two independent government sources rather than a single primary fetch.

Frequently Asked Questions

What is the TGA Special Access Scheme?

The Special Access Scheme (SAS) is the pathway that lets a registered Australian health practitioner access an unapproved therapeutic good — one not on the ARTG for the intended use — for a specific patient or defined group, outside a formal clinical trial. It runs under the Therapeutic Goods Act 1989 through three categories (A, B, C) distinguished by urgency and existing safety evidence.

What is the difference between SAS Category A, B, and C?

Category A is notification-only for seriously ill patients, with immediate use and TGA notification within 28 days. Category B requires a TGA-approved application before supply, typically taking 2 to 5 working days. Category C is notification-only, limited to products on a specific TGA-published list with an established history of safe use.

How is SAS different from the Authorised Prescriber (AP) scheme?

Both let a practitioner supply an unapproved product outside a trial, but SAS is scoped to an individual patient or a specific defined group assessed per request, while AP is limited to medical practitioners and designed for ongoing, repeat prescribing to an open-ended class of patients without a fresh request each time.

Does a clinical trial use SAS to supply its investigational product?

No. Supply of an unapproved good used IN a clinical trial is governed by the CTN or CTA scheme, not SAS. SAS applies only to access outside a formal trial — most commonly when a trial closes or a participant’s involvement ends but continued individual access to the same product is still needed.

Why does an SAS request matter to a research or clinical trials office, not just the prescribing clinician?

An SAS request that follows on from a closed or ending clinical trial carries the same product-history, sponsor-supply, and continuity questions the research office already manages under CTN/CTA. Confirming ARTG status and sponsor willingness to keep supplying the product are exactly the kind of checks a research governance office is positioned to catch that an individual treating clinician might not raise alone.