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Prescription medicines determination and designation notices

26 March 2020

On this page: What is determination? | What is designation? | Approved determinations and designations for prescription medicines

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.

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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 1 - 10 of 103

Dr Reddy's Laboratories Australia Pty Ltd

Designation/determination: Orphan drug

Effective Date: 25/03/2020

Lapse Date: 25/09/2020

Medicine Name: carboprost tromethamine

Dosage Form(s): Injection

Therapeutic area: Obstetrics and Gynaecology

Indication:

For the treatment of post partum haemorrhage due to uterine atony following failure of conventional treatments

Vertex Pharmaceuticals Australia Pty Ltd

Designation/determination: Orphan drug

Effective Date: 17/02/2020

Lapse Date: 17/08/2020

Medicine Name: tezacaftor, ivacaftor

Dosage Form(s): Film-coated tablet

Therapeutic area: Respiratory

Indication:

For the treatment of patients with cystic fibrosis

Specialised Therapeutics Pharma Pty Ltd

Designation/determination: Orphan drug

Effective Date: 17/02/2020

Lapse Date: 17/08/2020

Medicine Name: lurbinectedin

Dosage Form(s): IV injection/powder for solution;

Therapeutic area: Respiratory

Indication:

For the treatment of small cell lung cancer

Merck Sharp & Dohme (Australia) Pty Ltd

Designation/determination: Provisional approval

Effective Date: 11/02/2020

Lapse Date: 11/08/2020

Medicine Name: pembrolizumab

Therapeutic area: Oncology

ANSTO t/a ANSTO Health

Designation/determination: Orphan drug

Effective Date: 22/01/2020

Lapse Date: 22/07/2020

Medicine Name: Lutetium-177 chloride (non-carrier-added)

Dosage Form(s): solution

Therapeutic area: Oncology

Indication:

For the treatment of non resectable or metastatic neuroendocrine tumours (NETS) expressing somatostatin subtype 2 receptors when coupled with a suitable carrier molecule

Specialised Therapeutics Pharma Pty Ltd

Designation/determination: Orphan drug

Effective Date: 21/01/2020

Lapse Date: 21/07/2020

Medicine Name: trabectedin

Dosage Form(s): IV injection/powder for solution;

Therapeutic area: Oncology

Indication:

For the treatment of soft tissue sarcoma

Alphapharm Pty Ltd

Designation/determination: Priority review

Effective Date: 21/01/2020

Lapse Date: 21/07/2020

Medicine Name: rifampicin

Therapeutic area: Infectious diseases

Indication:

For the treatment of patients with Buruli ulcer. Rifampicin is usually recommended to be used in combination with another antibiotic for the treatment of Buruli ulcer

Alphapharm Pty Ltd

Designation/determination: Orphan drug

Effective Date: 21/01/2020

Lapse Date: 21/07/2020

Medicine Name: rifampicin

Dosage Form(s): capsule

Therapeutic area: Infectious diseases

Indication:

For the treatment of patients with Buruli ulcer. Rifampicin is usually recommended to be used in combination with another antibiotic for the treatment of Buruli ulcer

Roche Products Pty Limited

Designation/determination: Priority review

Effective Date: 10/01/2020

Lapse Date: 10/07/2020

Medicine Name: atezolizumab

Therapeutic area: Oncology

Indication:

atezolizumab in combinatinon with bevacizumab, is indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

Roche Products Pty Limited

Designation/determination: Orphan drug

Effective Date: 10/01/2020

Lapse Date: 10/07/2020

Medicine Name: atezolizumab

Dosage Form(s): concentrated injection

Therapeutic area: Oncology

Indication:

Treatment of hepatocellular carcinoma

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