How medicines and medical devices get approved in Australia

The standard route for a new prescription medicine, including biological medicines and vaccines. The agency runs the review in eight phases with fixed milestones. The rules set a limit of 255 working days from acceptance to decision.

Full application, new active substance · target 220 days · verified October 3, 2026

The route to add a new use, or to make a major change such as a new strength, dosage form or formulation, for a medicine already on the register when clinical, nonclinical or bioequivalence data are needed. It follows the same eight-phase process as a new medicine.

Full or mixed application, known active substance · verified October 3, 2026

A shortened review for a medicine already approved by a comparable overseas regulator within the last 12 months. The agency critically reviews the overseas assessment reports and evaluates the Australian label, Product Information and, where needed, the risk management plan. The legal limit is 120 working days.

Reliance route, abridged review · relies on CA, CH, EU, GB, JP, SG, US · verified October 3, 2026

A shortened review based mostly on the overseas assessment reports, with room for the agency to evaluate some extra data, such as updated stability data or a new manufacturing site. There is no limit on how old the overseas approval is. The legal limit is 175 working days.

Reliance route, abridged review · relies on CA, CH, EU, GB, JP, SG, US · verified October 3, 2026

A faster review for vital and life-saving prescription medicines with a complete dossier. The sponsor first obtains a priority determination. The registration review then has a target of 150 working days, with questions sent as they arise. The approval is the same as a standard approval.

Priority or accelerated review · target 150 days · verified October 3, 2026

Time-limited registration based on preliminary clinical data for a promising medicine, while the sponsor completes confirmatory studies. The sponsor first obtains a provisional determination. Provisional registration lasts 2 years and can be extended twice, by up to 2 years each time.

Conditional or accelerated approval · target 220 days · verified October 3, 2026

A designation for prescription medicines for rare conditions. It waives the application and evaluation fees for registration while it is in force. The designation lasts 6 months and can be extended once by 6 months. The registration itself can use any eligible pathway.

Orphan or rare disease designation · verified October 3, 2026

Australia works with Canada, Singapore, Switzerland and the United Kingdom on coordinated reviews. Each agency makes its own decision. There are work-sharing initiatives for new active substances, generic medicines and biosimilars.

Work-sharing or joint review · relies on CA, CH, GB, SG · verified October 3, 2026

A framework led by the US Food and Drug Administration for collaborative review of promising cancer medicines. The agency takes part and makes its own decision. Applications can go through the standard, provisional or priority review pathway.

Work-sharing or joint review · relies on US · verified October 3, 2026

A biosimilar is a version of a biological medicine already registered in Australia. The application meets the same requirements as other prescription medicines and uses the same milestone process. Comparability studies against the reference medicine are central.

Biosimilar application · verified October 3, 2026

The route for a generic version of a registered prescription medicine. It uses the same milestone process, with shorter planned first round and decision phases. Advisory committee review is optional.

Generic application · verified October 3, 2026

Non-prescription medicines are registered at one of five risk-based levels. N1 covers clones of an evaluated parent. N2 covers medicines that meet an OTC monograph. N3 and N4 cover generics, and N4 needs safety or efficacy data. N5 covers extensions and new chemical entities.

Non-prescription application · verified October 3, 2026

Products made from human cells or tissues, or from live animal cells, are regulated as biologicals in four risk classes. Class 2, 3 and 4 products need an evaluated dossier. Genetically modified cells, such as CAR T cells, are Class 4. The legal limit for evaluation is 255 working days.

Other route · target 220 days · verified October 3, 2026

There is no separate combination product route. The principal therapeutic effect decides whether the product follows the medicine, device or biological route. Integral single-use drug delivery products, such as auto-injectors, are usually regulated as medicines. Devices with an ancillary medicine, such as heparin-coated catheters, are usually regulated as devices.

Other route · verified October 3, 2026

The lowest risk devices are included in the register through a declaration process. The manufacturer applies the declaration of conformity procedure. For Class I devices, the sponsor sends the manufacturer's declaration of conformity with the application. Class 1 IVDs not for self-testing or point of care use a self-declaration.

Device: premarket notification · verified October 3, 2026

Most devices above the lowest risk are included in the register on the basis of manufacturer evidence. This evidence can be a certificate from the agency or from a comparable overseas regulator or assessment body. Some applications must be audited, but certain overseas approvals remove the mandatory audit.

Reliance route, recognition or verification · relies on CA, EU, GB, JP, SG, US · verified October 3, 2026

The agency itself can assess a manufacturer's quality system and, for high risk devices, the device design, and issue a conformity assessment certificate. When the design is examined, the rules set a decision limit of 255 working days, with clock stops for questions. Overseas reports can support an abridged assessment.

Device: conformity assessment by a certification body · verified October 3, 2026

A priority applicant determination gives front-of-queue handling for a register inclusion application or a conformity assessment application. It is for devices for serious conditions with unmet need and a major clinical advantage, or IVDs with a major public health benefit.

Device: breakthrough or priority program · verified October 3, 2026