no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods) or.Comparison with registered therapeutic goods the Medicines and Healthcare Products Regulatory Agency of the United Kingdom Ħ.the United States Food and Drug Administration.None of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine's safety: It is not likely that it would be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) of the Regulations were waived in relation to the medicineĥ. it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) of the Regulations were waived in relation to the medicine.if the medicine is intended to prevent or diagnose the condition the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register.if the medicine is intended to treat the condition – the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made.It is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class The indication is the treatment, prevention or diagnosis of a life-threatening or seriously debilitating condition The indication is the treatment, prevention or diagnosis of a life-threatening or seriously debilitating condition in a particular class of patients (the relevant patient class) The application is for only one indication of the medicine Orphan drug eligibility criteria Application type a syrup), where a tablet is already registered.Ĭombinations of medicines that are not fixed dose combinations require separate applications (one for each component of the non-fixed dose combination). An example of a new dosage form medicine is a new oral liquid dose form (e.g. Eligibility for new dosage form medicines is intended to provide an incentive to sponsors to register medicines on the Australian Register of Therapeutic Goods (ARTG) that introduce a new dosage form that would not be financially viable in the absence of a TGA fee waiver. In addition to the standard orphan designation, a pathway to seek orphan designation for new dosage form medicines is available. an already registered medicine with a new orphan indication, a new dosage form medicine or a major variation application that meets all relevant criteria including the significant benefit criterionĮligibility criteria for the Orphan Drug designationĪ medicine, including vaccines or in vivo diagnostic agents, may be eligible for orphan drug designation if all orphan criteria in the table below are satisfied (regulation 16J of the Therapeutic Goods Regulations 1990 (the Regulations)).Orphan drug designation may be granted for: On this page: Eligibility for orphan drug designation | Orphan drug designation | Supporting documentation requirements | Content of the designation application | Definitions | Flowchart guide to determine eligibility for standard orphan designation | References Eligibility for orphan drug designationĬonsider all of the eligibility criteria below before you lodge a designation application.
ORPHAN DRUG DESIGNATION REGISTRATION
Please read the guidance on the Prescription medicines registration process for assistance with registration. This guidance is for sponsors preparing an application for orphan drug designation and covers eligibility criteria and supporting documentation.įor assistance with the orphan designation process, please refer to the guidance for sponsors seeking prescription medicines orphan drug designation.
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