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Prescription medicines determination and designation notices

16 March 2021

On this page: What is determination? | What is designation? | Approved determinations and designations for prescription medicines

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.

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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 162

PTC Therapeutics Australia Pty Ltd

Designation/determination: Orphan drug

Effective Date: 09/03/2021

Lapse Date: 09/09/2021

Medicine Name: ataluren

Dosage Form(s): granules for oral suspension

Therapeutic area: Musculoskeletal

Indication

For the treatment of patients with Duchenne muscular dystrophy

Link Medical Products Pty Ltd

Designation/determination: Orphan drug

Effective Date: 25/02/2021

Lapse Date: 25/08/2021

Medicine Name: thiotepa

Dosage Form(s): Powder for injection/Solution for infusion

Therapeutic area: Oncocoloy

Indication

Thiotepa is indicated in combination with other chemotherapy medicinal products as conditioning treatment prior to Haematopoietic Progenitor Cell Transplantation (HPCT)

Merck Sharp & Dohme (Australia) Pty Ltd

Designation/determination: Provisional approval

Effective Date: 09/02/2021

Lapse Date: 09/08/2021

Medicine Name: belzutifan

Therapeutic area: Oncology

Merck Sharp & Dohme (Australia) Pty Ltd

Designation/determination: Orphan drug

Effective Date: 09/02/2021

Lapse Date: 09/08/2021

Medicine Name: belzutifan

Dosage Form(s): Immediate-release tablet

Therapeutic area: Oncology

Indication

For the treatment of von Hippel-Lindau (VHL) disease

Biocelect Pty Ltd

Designation/determination: Provisional approval

Effective Date: 19/01/2021

Lapse Date: 19/07/2021

Medicine Name: SARS-CoV-2 rS (NVX-CoV2373)

Therapeutic area: Infectious diseases

Indication

Active immunisation of adults ? 18 years of age for the prevention of disease caused by SARS-CoV-2

Reach Pharmaceuticals Pty Ltd

Designation/determination: Orphan drug

Effective Date: 07/01/2021

Lapse Date: 07/07/2021

Medicine Name: thiotepa

Dosage Form(s): Powder for injection

Therapeutic area: Oncogoly

Indication

Indicated in combination with other chemotherapy medicinal products as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT)

Merck Sharp & Dohme (Australia) Pty Ltd

Designation/determination: Provisional approval

Effective Date: 07/01/2021

Lapse Date: 07/07/2021

Medicine Name: human papillomavirus 9-valent vaccine

Therapeutic area: Infectious diseases

Amgen Australia Pty Ltd

Designation/determination: Provisional approval

Effective Date: 07/01/2021

Lapse Date: 07/07/2021

Medicine Name: sotorasib

Therapeutic area: Oncology

Novartis Pharmaceuticals Australia Pty Ltd

Designation/determination: Orphan drug

Effective Date: 21/12/2020

Lapse Date: 21/06/2021

Medicine Name: ruxolitinib (as phosphate)

Dosage Form(s): tablets

Therapeutic area: Immunology

Indication

Jakavi is indicated for the treatment of patients with Graft versus Host Disease (GvHD).

Novartis Pharmaceuticals Australia Pty Ltd

Designation/determination: Priority review

Effective Date: 21/12/2020

Lapse Date: 21/06/2021

Medicine Name: ruxolitinib (as phosphate)

Therapeutic area: Immunology

Indication

Jakavi is indicated for the treatment of patients with Graft versus Host Disease (GvHD) 12 years and older who have inadequate response to corticosteroids or other systemic therapies

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