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Prescription medicines determination and designation notices

14 October 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

Displaying 1 - 10 of 139

Pfizer Australia Pty Ltd

Designation/determination: Provisional approval

Effective Date: 14/10/2020

Lapse date: 14/04/2021

Medicine Name: BNT162b2 [mRNA]

Therapeutic area: Infectious diseases

Active immunisation against COVID-19 disease caused by SARS-CoV-2 virus in individuals aged 16 years and over

AstraZeneca Pty Ltd

Designation/determination: Provisional approval

Effective Date: 09/10/2020

Lapse date: 09/04/2021

Medicine Name: ChAdOx1-S [recombinant]

Therapeutic area: Infectious diseases

For the prevention of COVID-19

Sanofi-Aventis Australia Pty Ltd

Designation/determination: Orphan drug

Effective Date: 15/09/2020

Lapse date: 15/03/2021

Medicine Name: avalglucosidase alfa

Dosage Form(s): Powder for injection

Therapeutic area: Inherited metabolic disorders

Avalglucosidase alfa is intended for long-term enzyme replacement therapy (ERT) for the treatment of patients with Pompe disease (acid ?-glucosidase deficiency)

Kadmon Oceania Pty Ltd

Designation/determination: Priority review

Effective Date: 15/09/2020

Lapse date: 15/03/2021

Medicine Name: belumosudil

Therapeutic area: Oncology

Treatment of patients 12 years and older with chronic Graft Versus Host Disease (GVHD) after failure of at least one prior line of systemic therapy

GlaxoSmithKline Australia Pty Ltd

Designation/determination: Provisional approval

Effective Date: 15/09/2020

Lapse date: 15/03/2021

Medicine Name: dostarlimab

Therapeutic area: Oncology

Merck Healthcare Pty Ltd

Designation/determination: Orphan drug

Effective Date: 10/09/2020

Lapse date: 10/03/2021

Medicine Name: tepotinib (as hydrochloride monohydrate)

Dosage Form(s): Film-coated tablet

Therapeutic area: Oncology

For the treatment of non-small cell lung cancer (NSCLC) with genetic MET alterations

Kadmon Oceania Pty Ltd

Designation/determination: Orphan drug

Effective Date: 04/09/2020

Lapse date: 04/03/2021

Medicine Name: belumosudil

Dosage Form(s): Film-coated tablet

Therapeutic area: Oncology

Treatment of Graft versus Host Disease

Apellis Australia Pty Ltd

Designation/determination: Orphan drug

Effective Date: 04/09/2020

Lapse date: 04/03/2021

Medicine Name: pegcetacoplan

Dosage Form(s): Solution for injection

Therapeutic area: Haematology

Treatment of patients with paroxysmal nocturnal haemoglobinuria (PNH)

AstraZeneca Pty Ltd

Designation/determination: Priority review

Effective Date: 13/08/2020

Lapse date: 13/02/2021

Medicine Name: osimertinib [as mesilate]

Therapeutic area: Oncology

For the adjuvant treatment after tumour resection in patients with non-small cell lung cancer (NSCLC) whose tumours have activating epidermal growth factor receptor (EGFR) mutations

Recordati Rare Diseases Australia Pty Ltd

Designation/determination: Orphan drug

Effective Date: 31/07/2020

Lapse date: 31/01/2021

Medicine Name: cysteamine hydrochloride

Dosage Form(s): eye drop solution

Therapeutic area: Ophthalmology

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

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