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.
What is designation?
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.
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.
Does a determination or designation mean that the medicine is registered?
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
Period for which a determination or designation remains in force
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.