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Prescription medicines determination and designation notices

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

Recordati Rare Diseases Australia Pty Ltd

Designation/determination: Orphan drug

Effective Date: 15/08/2019

Lapse Date: 15/02/2020

Medicine Name: chlormethine (as chlormethine hydrochloride)

Dosage Form(s): Topical gel

For the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-type CTCL)

Therapeutic area: Haematology

Waymade Australia Pty Limited

Designation/determination: Orphan drug

Effective Date: 07/08/2019

Lapse Date: 07/02/2020

Medicine Name: trientine hydrochloride

Dosage Form(s): capsule

Treatment of Wilson's Disease

Therapeutic area: Inherited metabolic disorders

AstraZeneca Pty Ltd

Designation/determination: Provisional approval

Effective Date: 17/07/2019

Lapse Date: 17/01/2020

Medicine Name: acalabrutinib

Therapeutic area: Oncology

Sanofi-Aventis Australia Pty Ltd

Designation/determination: Provisional approval

Effective Date: 16/07/2019

Lapse Date: 16/01/2020

Medicine Name: cemiplimab

Therapeutic area: Oncology

Recordati Rare Diseases Australia Pty Ltd

Designation/determination: Orphan drug

Effective Date: 16/07/2019

Lapse Date: 16/01/2020

Medicine Name: cysteamine hydrochloride

Dosage Form(s): Eye drops, solution

Treatment of corneal cystine deposits in cystinosis in adults and children over two years of age

Therapeutic area: Ophthalmology

Kyowa Kirin Australia Pty Ltd

Designation/determination: Orphan drug

Effective Date: 16/07/2019

Lapse Date: 16/01/2020

Medicine Name: burosumab

Dosage Form(s): Solution for subcutaneous Injection

Treatment of X-linked hypophosphataemia (XLH)

Therapeutic area: Endocrinology

JACE Pharma Pty Ltd

Designation/determination: Orphan drug

Effective Date: 03/07/2019

Lapse Date: 03/01/2020

Medicine Name: trientine tetrahydrochloride

Dosage Form(s): Film-coated tablet

Treatment of Wilson's Disease

Therapeutic area: Inherited metabolic disorders

Emerge Health Pty Ltd

Designation/determination: Orphan drug

Effective Date: 24/06/2019

Lapse Date: 24/12/2019

Medicine Name: dinutuximab beta

Dosage Form(s): intravenous infusion

For the treatment of Neuroblastoma

Therapeutic area: Oncology

Emerge Health Pty Ltd

Designation/determination: Priority review

Effective Date: 24/06/2019

Lapse Date: 24/12/2019

Medicine Name: dinutuximab beta

Qarziba is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months and above who have previously received induction chemotherapy and achieved at least a partial response followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma, with or without residual disease. Prior to the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilised by other suitable measures. In patients with a history of relapsed or refractory disease and in patients who have not achieved a complete response after first line therapy, Qarziba should be combined with interIeukin-2 (IL-2).

Therapeutic area: Oncology

Dr Falk Pharma Australia Pty Ltd

Designation/determination: Orphan drug

Effective Date: 20/06/2019

Lapse Date: 20/12/2019

Medicine Name: budesonide

Dosage Form(s): Orodispersible tablet

For the treatment of eosinophilic oesophagitis (EoE)

Therapeutic area: Gastroenterology

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