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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 11 - 20 of 196

Teva Pharma Australia Pty Ltd

Designation/determination: Orphan drug

Effective Date: 17/08/2021

Lapse Date: 17/02/2022

Medicine Name: edaravone

Dosage Form(s): concentrated solution for injection

Therapeutic area: Neurology

For the treatment of amyotrophic lateral sclerosis (ALS)

Merck Sharp & Dohme (Australia) Pty Ltd

Designation/determination: Provisional approval

Effective Date: 09/08/2021

Lapse Date: 09/02/2022

Medicine Name: molnupiravir

Therapeutic area: Infectious diseases

For treatment of COVID-19 in adults

Sanofi-Aventis Australia Pty Ltd

Designation/determination: Provisional approval

Effective Date: 19/07/2021

Lapse Date: 19/01/2022

Medicine Name: cemiplimab

Therapeutic area: Oncology

Merck Healthcare Pty Ltd

Designation/determination: Orphan drug

Effective Date: 02/07/2021

Lapse Date: 02/01/2022

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

Merck Healthcare Pty Ltd

Designation/determination: Provisional approval

Effective Date: 02/07/2021

Lapse Date: 02/01/2022

Medicine Name: tepotinib (as hydrochloride monohydrate)

Therapeutic area: Oncology

Moderna Australia Pty Ltd

Designation/determination: Provisional approval

Effective Date: 24/06/2021

Lapse Date: 24/12/2021

Medicine Name: elasomeran

Therapeutic area: Infectious diseases

For active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older

Recordati Rare Diseases Australia Pty Ltd

Designation/determination: Orphan drug

Effective Date: 22/06/2021

Lapse Date: 22/12/2021

Medicine Name: hemin

Dosage Form(s): Powder for injection

Therapeutic area: Haematology

Indicated for the treatment of acute attacks of hepatic porphyria (acute intermittent porphyria, porphyria variegate, hereditary corproporphyria and delta-aminolevulinic acid dehydratase porphyria)

PPD Australia Pty Ltd

Designation/determination: Orphan drug

Effective Date: 17/06/2021

Lapse Date: 17/12/2021

Medicine Name: crisantaspase

Dosage Form(s): lyophilized powder for solution for injection/infusion

Therapeutic area: Oncology

Indicated in combination with other chemotherapeutic agents to treat patients with paediatric acute lymphoblastic leukaemia (ALL)

BioMarin Pharmaceuticals Australia Pty Ltd

Designation/determination: Orphan drug

Effective Date: 16/06/2021

Lapse Date: 16/12/2021

Medicine Name: vosoritide

Dosage Form(s): Powder for injection and water for injection

Therapeutic area: Inherited bone disorder

For the treatment of achondroplasia (ACH)

Link Medical Products Pty Ltd

Designation/determination: Orphan drug

Effective Date: 11/06/2021

Lapse Date: 11/12/2021

Medicine Name: treosulfan

Therapeutic area: Haematology

Treosulfan is indicated for the conditioning treatment prior to haematopoietic stem cell transplantion

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