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Prescription medicines determination and designation notices

13 January 2020

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

Roche Products Pty Limited

Designation/determination: Priority review

Effective Date: 10/01/2020

Lapse Date: 10/07/2020

Medicine Name: atezolizumab

Therapeutic area: Oncology

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

Treatment of hepatocellular carcinoma

Otsuka Australia Pharmaceuticals Pty Ltd

Designation/determination: Orphan drug

Effective Date: 08/01/2020

Lapse Date: 08/07/2020

Medicine Name: decitabine and cedazuridine

Dosage Form(s): Film-coated tablet

Therapeutic area: Haematology

Treatment of adult patients with MDS intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups, and patients with chronic myelomonocytic leukemia (CMML).

AA-Med Pty Ltd

Designation/determination: Priority review

Effective Date: 08/01/2020

Lapse Date: 08/07/2020

Medicine Name: tucatinib

Indicated in combination with trastuzumab and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received at least 3 prior HER2-directed agents separately or in combination, in the neoadjuvant, adjuvant, or metastatic setting.

Emerge Health Pty Ltd

Designation/determination: Priority review

Effective Date: 18/12/2019

Lapse Date: 18/06/2020

Medicine Name: cannabidiol

Therapeutic area: Neurology

Indicated for use as adjunctive therapy of seizures associated with Dravet syndrome (DS) for patients 2 years of age and older

Emerge Health Pty Ltd

Designation/determination: Priority review

Effective Date: 18/12/2019

Lapse Date: 18/06/2020

Medicine Name: cannabidiol

Therapeutic area: Neurology

Indicated for use as adjunctive therapy of seizures associated with Lennox-Gastaut syndrome (LGS) for patients 2 years of age and older

Vertex Pharmaceuticals Australia Pty Ltd

Designation/determination: Orphan drug

Effective Date: 11/12/2019

Lapse Date: 11/06/2020

Medicine Name: elexacaftor, tezacaftor and ivacaftor

Dosage Form(s): Film-coated tablet

Therapeutic area: Respiratory

For the treatment of cystic fibrosis in patients who have at least one F508del mutation in the CFTR gene

Kyowa Kirin Australia Pty Ltd

Designation/determination: Orphan drug

Effective Date: 11/12/2019

Lapse Date: 11/06/2020

Medicine Name: mogamulizumab

Dosage Form(s): Solution for IV administration

Therapeutic area: Haematology

For the treatment of cutaneous t-cell lympphoma

Tudorrose Consulting Pty Ltd

Designation/determination: Priority review

Effective Date: 04/12/2019

Lapse Date: 04/06/2020

Medicine Name: ripretinib

Therapeutic area: Oncology

Treatment of patients with advanced gastrointestinal stromal tumours (GIST), who have received prior treatment with imatinib, sumitinib and regorafenib.

Tudorrose Consulting Pty Ltd

Designation/determination: Orphan drug

Effective Date: 04/12/2019

Lapse Date: 04/06/2020

Medicine Name: ripretinib

Dosage Form(s): Tablet

Therapeutic area: Oncology

For the treatment of gastrointestinal stromal tumours (GIST)

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