Prescription medicines determination and designation notices

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

Ipsen Pty Ltd

Designation/determination: Orphan drug

Effective Date: 17/07/2018

Lapse Date: 17/01/2019

Medicine Name: mecasermin

Dosage Form(s): Injection, solution

Mecasermin is indicated for the long-term treatment of growth failure in children and adolescents with severe primary insulin-like growth factor-1 deficiency (severe primary IGFD).

Therapeutic area: Endocrinology

Teruma BCT Australia Pty Ltd

Designation/determination: Orphan drug

Effective Date: 21/06/2018

Lapse Date: 21/12/2018

Medicine Name: methoxsalen

Dosage Form(s): solution

Treatment of Cutaneous T-Cell Lymphoma (CTCL

Therapeutic area: Haematology

Novartis Pharmaceuticals Australia Pty Ltd

Designation/determination: Priority review

Effective Date: 21/06/2018

Lapse Date: 21/12/2018

Medicine Name: eltrombopag olamine

Dosage Form(s): Powder for oral suspension & Tablet, film-coated

Eltrombopag olamine in combination with standard immunosuppressive therapy (IST) for the first-line treatment of patients 2 years and older with severe aplastic anaemia (SAA).

Therapeutic area: Haematology

Teruma BCT Australia Pty Ltd

Designation/determination: Orphan drug

Effective Date: 19/06/2018

Lapse Date: 19/12/2018

Medicine Name: methoxsalen

Dosage Form(s): solution

For the treatment of Graft versus Host Disease (GVHD) following allogeneic Hematopoietic Stem Cell (HSC) transplantation.

Therapeutic area: Immunology

Merck Sharp & Dohme (Australia) Pty Ltd

Designation/determination: Priority review

Effective Date: 23/05/2018

Lapse Date: 23/11/2018

Medicine Name: pembrolizumab

Pembrolizumab in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumour aberrations.

JACE Pharma Pty Ltd

Designation/determination: Orphan drug

Effective Date: 23/05/2018

Lapse Date: 23/11/2018

Medicine Name: cenegermin

Dosage Form(s): Eye drops, solution

For the treatment of neurotrophic keratitis

Merck Sharp & Dohme (Australia) Pty Ltd

Designation/determination: Provisional approval

Effective Date: 16/05/2018

Lapse Date: 16/11/2018

Medicine Name: pembrolizumab

Therapeutic area: Oncology

Celgene Pty Ltd

Designation/determination: Orphan drug

Effective Date: 30/04/2018

Lapse Date: 30/10/2018

Medicine Name: enasidenib

Dosage Form(s): Tablet, film-coated

For the treatment of patients with acute myeloid leukaemia with an isocitrate dehydrogenase-2 (IDH2) mutation.

Eli Lilly Australia Pty Ltd

Designation/determination: Provisional approval

Effective Date: 12/04/2018

Lapse Date: 12/10/2018

Medicine Name: olaratumab (rmc)

Therapeutic area: Oncology

Roche Products Pty Limited

Designation/determination: Priority review

Effective Date: 22/03/2018

Lapse Date: 22/09/2018

Medicine Name: emicizumab

Emicizumab is indicated for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in patients with haemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors.

Pages