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Prescription medicines determination and designation notices

22 November 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 201 - 210 of 211

Novartis Pharmaceuticals Australia Pty Ltd

Designation/determination: Priority review

Effective Date: 13/12/2017

Lapse Date: 13/06/2018

Registration date: 08/06/2018

Medicine Name: dabrafenib

Dabrafenib, in combination with trametinib, is indicated for the adjuvant treatment of patients with Stage III melanoma with a BRAF V600 mutation, following complete resection.

BioMarin Pharmaceuticals Australia Pty Ltd

Designation/determination: Priority review

Effective Date: 30/11/2017

Lapse Date: 30/05/2018

Registration date: 28/08/2018

Medicine Name: cerliponase alfa

For the treatment of neuronal ceroid lipofuscinosis type 2 (CLN2) disease, also known as tripeptidyl peptidase 1 (TPP1) deficiency.

Merck Sharp & Dohme (Australia) Pty Ltd

Designation/determination: Orphan drug

Effective Date: 28/11/2017

Lapse Date: 28/05/2018

Medicine Name: pembrolizumab

Dosage Form(s): Injection solution

For the treatment of adult and paediatric patients with primary mediastinal B-cell lymphoma

AstraZeneca Pty Ltd

Designation/determination: Priority Review

Effective Date: 24/11/2017

Lapse Date: 24/05/2018

Registration date: 05/07/2018

Medicine Name: osimertinib

Dosage Form(s): Tablet

For the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations

Bristol-Myers Squibb Australia Pty Ltd

Designation/determination: Priority review

Effective Date: 10/11/2017

Lapse Date: 10/05/2018

Registration date: 09/07/2018

Medicine Name: nivolumab

Nivolumab in combination with ipilimumab, is indicated for the treatment of patients with intermediate/poor risk advanced renal cell carcinoma (RCC)

BioMarin Pharmaceuticals Australia Pty Ltd

Designation/determination: Orphan drug

Effective Date: 08/11/2017

Lapse Date: 08/05/2018

Medicine Name: cerliponase alfa

Dosage Form(s): Injection

For the treatment of neuronal ceroid lipofuscinosis type 2 (CLN2) disease, also known as tripeptidyl peptidase 1 (TPP1) deficiency.

Bristol-Myers Squibb Australia Pty Ltd

Designation/determination: Priority Review

Effective Date: 28/09/2017

Lapse Date: 28/03/2018

Registration date: 24/04/2018

Medicine Name: nivolumab

For the adjuvant treatment of Stage III/IV melanoma in patients who have undergone complete resection.

BioMarin Pharmaceuticals Australia Pty Ltd

Designation/determination: Orphan Drug

Effective Date: 19/09/2017

Lapse Date: 19/03/2018

Medicine Name: sapropterin Dihydrochloride

Dosage Form(s): Tablet

For the treatment of hyperphenylalaninemia (HPA) in patients with phenylketonuria (PKU) or tetrahydrobiopterin- (BH4-) deficiency.

Roche Products Pty Limited

Designation/determination: Priority review

Effective Date: 29/08/2017

Lapse Date: 28/02/2018

Registration date: 23/02/2018

Medicine Name: emicizumab

For routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in patients with haemophilia A (congenital factor Vlll deficiency) with factor Vlll inhibitors. HEMLIBRA can be used in all age groups.

Roche Products Pty Limited

Designation/determination: Orphan drug

Effective Date: 25/08/2017

Lapse Date: 25/02/2018

Registration date: 23/02/2018

Medicine Name: emicizumab

Dosage Form(s): Injection solution

For routine prophylaxis in patients with haemophilia A (congenital factor Vlll deficiency)

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