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Prescription medicines determination and designation notices

20 September 2021

What is determination?

Determination is a formal process that allows the TGA to make a decision regarding whether a medicine is eligible for registration via the provisional approval pathway or the priority review pathway.

The sponsor of the medicine must submit an application for determination to allow the TGA to make a decision on whether the medicine meets the eligibility criteria. These eligibility criteria are designed to ensure that only products providing the most benefit to patients are eligible. Eligibility criteria for provisional determination and priority review determination are published on our website.

Designation is similar to determination, but in this case, it allows the TGA to make a decision regarding whether a medicine is eligible for Orphan drug status. More information on our orphan drug program is available at the Orphan drug program reforms webpage.

Amendments to the Therapeutic Goods Regulations 1990 which came into effect on 1 July 2017 changed the eligibility criteria for orphan drug designation. A transition period applies to orphan drugs designated under the previous orphan drug program. A list of orphan drugs designated under the previous program is available.

A determination or designation does not mean that the medicine has been approved and registered in the Australian Register of Therapeutic Goods (ARTG).

To register a medicine after obtaining a designation or determination, the sponsor must lodge an application for registration. These applications are subject to a rigorous evaluation process resulting in a TGA decision on whether the medicine should be registered on the ARTG. Details of registered products approved for supply in Australia can be obtained by searching the ARTG

Orphan designations, priority review and provisional determinations remain in force for a period of 6 months from the initial effective date.

Provisional determinations and orphan drug designations may be extended for a further six months on application by the sponsor. We will grant one extension if all eligibility criteria for the relevant extension are met. A priority review determination cannot be extended.

Details of prescription medicines that have an approved provisional determination, priority review determination or orphan drug designation are listed below.

Approved determinations and designations for prescription medicines

Displaying 71 - 80 of 196

Bristol-Myers Squibb Australia Pty Ltd

Designation/determination: Priority review

Effective Date: 20/07/2020

Lapse Date: 20/01/2021

Medicine Name: nivolumab

Therapeutic area: Oncology

Opdivo in combination with ipilimumab, is indicated for the first-line treatment of patients with unresectable malignant pleural mesothelioma

Bristol-Myers Squibb Australia Pty Ltd

Designation/determination: Priority review

Effective Date: 20/07/2020

Lapse Date: 20/01/2021

Medicine Name: ipilimumab

Therapeutic area: Oncology

Yervoy in combination with nivolumab, is indicated for the first-line treatment of patients with unresectable malignant pleural mesothelioma

Alphapharm Pty Ltd

Designation/determination: Orphan drug

Effective Date: 20/07/2020

Lapse Date: 20/01/2021

Medicine Name: pretomanid

Dosage Form(s): Tablet

Therapeutic area: Infectious diseases

Indicated in combination with bedaquiline and linezolid, in adults, for the treatment of pulmonary extensively drug resistant (XDR), or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB)

Kyowa Kirin Australia Pty Ltd

Designation/determination: Orphan drug

Effective Date: 16/07/2020

Lapse Date: 16/01/2021

Medicine Name: burosumab

Dosage Form(s): Solution for injection

Therapeutic area: Endocrinology

for the treatment of X-linked hypophosphataemia

Kyowa Kirin Australia Pty Ltd

Designation/determination: Priority review

Effective Date: 16/07/2020

Lapse Date: 16/01/2021

Medicine Name: burosumab

Therapeutic area: Endocrinology

for the treatment of X-linked hypophosphataemia in adult and paediatric patients 1 year of age or older

Pierre Fabre Australia Pty Ltd

Designation/determination: Priority review

Effective Date: 10/07/2020

Lapse Date: 10/01/2021

Medicine Name: encorafenib

Dosage Form(s): Hard capsule

Therapeutic area: Oncology

For the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation as detected by a validated test, who have received prior systemic therapy

Gilead Sciences Pty Ltd

Designation/determination: Provisional approval

Effective Date: 06/07/2020

Lapse Date: 06/01/2021

Medicine Name: remdesivir

Therapeutic area: Infectious diseases

Vertex Pharmaceuticals Australia Pty Ltd

Designation/determination: Orphan drug

Effective Date: 03/07/2020

Lapse Date: 03/01/2021

Medicine Name: ivacaftor

Dosage Form(s): Granules

Therapeutic area: Respiratory

For the treatment of cystic fibrosis

Roche Products Pty Limited

Designation/determination: Orphan drug

Effective Date: 30/06/2020

Lapse Date: 30/12/2020

Medicine Name: risdiplam

Dosage Form(s): Powder for oral solution

Therapeutic area: Neurology

For the treatment of Spinal Muscular Atrophy (SMA)

Roche Products Pty Limited

Designation/determination: Priority review

Effective Date: 30/06/2020

Lapse Date: 30/12/2020

Medicine Name: risdiplam

Therapeutic area: Neurology

For the treatment of 5q Spinal Muscular Atrophy (SMA)

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