You are here

Prescription medicines determination and designation notices

20 September 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 181 - 190 of 196

Shire Australia Pty Limited

Designation/determination: Orphan drug

Effective Date: 21/02/2018

Lapse Date: 21/08/2018

Medicine Name: lanadelumab

Dosage Form(s): Injection solution

For the routine prevention of angioedema attacks and control of symptoms of hereditary angioedema (HAE) in adolescents and adults

Eli Lilly Australia Pty Ltd

Designation/determination: Orphan drug

Effective Date: 09/02/2018

Lapse Date: 09/08/2018

Medicine Name: olaratumab (rmc)

Dosage Form(s): Injection, intravenous infusion

For the treatment of soft tissue sarcoma

Janssen-Cilag Pty Ltd

Designation/determination: Priority review

Effective Date: 17/01/2018

Lapse Date: 18/07/2018

Registration date: 05/07/2018

Medicine Name: apalutamide

Dosage Form(s): Tablet

For the treatment of patients with castration-resistant prostate cancer at risk of developing metastases

Vertex Pharmaceuticals Australia Pty Ltd

Designation/determination: Orphan drug

Effective Date: 14/12/2017

Lapse Date: 14/06/2018

Medicine Name: tezacaftor/ivacaftor

Dosage Form(s): Tablet

For the treatment of patients with cystic fibrosis (CF) aged 12 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regualtor (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence

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: trametinib

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

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)

Pages