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This guidance is to help sponsors understand the eligibility criteria and supporting documentation requirements for a biological to be eligible for priority determination.
For guidance on the process of applying for priority determination, refer to Biologicals (priority applicant) Determination: A step-by-step guide.
If you intend to lodge a priority determination application and either of the following applies, email bloodandtissues@health.gov.au at least 1 month before lodgement:
Before notifying us of your intent to lodge a priority determination application, consider all the following eligibility criteria and supporting documentation requirements.
A biological product may be eligible for priority determination if all eligibility criteria in the following table are satisfied (regulation 16W of the Therapeutic Goods Regulations 1990.
| Eligibility criteria | Requirements for satisfying the eligibility criteria |
|---|---|
| The biological is a separate and distinct Class 2 ,3 or 4 biological, generally it will be either:
|
| The biological is indicated for either:
|
| Either:
|
| 4. Major therapeutic advance | There is substantial evidence demonstrating that the biological provides a major therapeutic advance. |
Under subregulation 16W(3) of the Therapeutic Goods Regulations 1990, a priority determination is specific to the:
A priority determination only applies to a specific biological for a specific indication.
The proposed priority indication at the time of determination may be different to that subsequently approved at the time of inclusion of a biological in the Australian Register of Therapeutic Goods (ARTG).
The approved indication will be based on our assessment of the quality, safety and efficacy data submitted with the inclusion application.
You can apply for only one biological and one priority indication in a determination application.
If you are seeking determination for multiple priority indications, you must submit one application for each indication.
An application that includes a combination of priority and non-priority indications will not be eligible for assessment under the priority review pathway.
However, multiple priority determinations may apply to one priority review application.
The main body of your application should be no more than 10 pages. Include any additional supporting documentation as attachments.
The main body should address:
Attachments can include:
We will determine the validity of the justifications against the eligibility criteria on a case-by-case basis.
As part of the routine determination process, the extent to which criteria are met will be assessed at the time a decision is made on the application.
The biological must be a Class 2, 3 or 4 biological which is separate and distinct.
A separate and distinct biological is generally either:
You need to justify the severity of the disease (that is, its seriously debilitating or life- threatening nature) in Australia based on objective and quantifiable medical information.
Your determination application must justify the:
The serious debilitation or fatal outcome should be a prominent feature of both the target disease or condition and therapeutic indication (that is, affect an important portion of the target population).
The priority indication associated with your determination application should be the same as that proposed for inclusion in the Australian Register of Therapeutic Goods (ARTG).
You must establish either that:
Any reference to a therapeutic good in the ARTG must be limited to the conditions of the relevant ARTG entry. A therapeutic good that is used outside the approved product information (that is, ‘off-label’ use) cannot be considered an existing therapeutic good for the purposes of the Therapeutic Goods Regulations 1990.
Provisionally registered goods in the ARTG are excluded from this comparison.
You must review goods in the Australian Register of Therapeutic Goods (ARTG) for diagnosis, prevention, or treatment for the proposed priority indication in Australia and provide:
You must demonstrate that there is substantial evidence that the biological provides an advantage over therapeutic goods in the ARTG for the priority indication (for treatment, prevention, or diagnosis of the condition) that is the subject of the determination application.
You can do this by addressing either of the following:
If new therapeutic goods for the diagnosis, prevention or treatment of your proposed priority indication are included in the ARTG after you lodge your application, you will have the opportunity to submit a further justification of significant improvement in safety or efficacy in relation to those goods before a decision is made on your application.
Supporting evidence should be based on clinical trial data. Increased safety or efficacy should be demonstrated through established safety and efficacy endpoints that demonstrate direct clinical benefit.
Comparator studies are expected to be generated (pivotal study reports). Scientific argument and/or justification for the significant improvement in safety or efficacy of the biological relative to products not studied in available clinical trials (this may involve cross study comparisons) may be considered.
For a claim of improved efficacy or safety, we will evaluate whether there is a high probability that patients will experience a clinically relevant benefit. It is critical this claim be supported by robust evidence from summaries of full study reports that form the basis of the intended inclusion application and justifications presented by the sponsor.
The evidence and/or data must take into account the particular characteristics of the condition (life expectancy, symptoms) and existing therapeutic goods in the ARTG for the treatment, prevention or diagnosis of the proposed therapeutic indication.
We will not assess significant benefit against comparator products that are the subject of:
Safety of diagnostic agents should be justified in the same way as for all other therapeutic goods. However, you should also consider diagnostic performance (sensitivity and specificity), predictive values and likelihood ratios in addition to other endpoints.
For further information refer to Guideline on Clinical Evaluation of Diagnostic Agents.
Your determination application must provide justification that there is substantial evidence that the biological is a major therapeutic advance based on the following aspects:
You must include an assessment of the magnitude of the demonstrated improvement in safety or efficacy based on established safety and efficacy endpoints.
Demonstration of a biological’s clinically significant benefit based on improved safety and/or efficacy is not sufficient. You must demonstrate that there is a major benefit beyond the level that could be described as clinically significant. For example, a major improvement in mortality endpoints.
Even if the benefit appears in one aspect only, you must assess the overall impact on patient outcomes considering both safety and efficacy.
Patient-reported outcomes may be provided but are not a universal requirement (dependent on the setting).
The biological should provide a substantial therapeutic advance in comparison with other therapeutic goods in the Australian Register of Therapeutic Goods (ARTG).
You must demonstrate that your biological substantially addresses a major or urgent unmet need for Australian patients. You must describe:
The description of the strength of evidence should include a brief outline of the main available evidence on which the claim is based. For example, the number and type of clinical trials with clear delineation of pivotal versus supporting studies, sample size, design and key results. For further information on cross study comparisons, refer to the section on supporting evidence under Criterion 3.
A biological that demonstrates significant improvement in safety or efficacy may constitute a major therapeutic advance if for example, the biological demonstrates beneficial therapeutic effects that are considerably higher than those observed in previous treatment options. It may also replace standard treatment which has poor tolerability and potential for serious side effects.
Title changed from 'Biologicals (priority applicant) determination - Eligibility criteria and supporting documentation requirements' to 'Meeting the eligibility criteria for priority determination applications: biologicals' as part of migration to new 'Guidance' content type:
Original publication.
Title changed from 'Biologicals (priority applicant) determination - Eligibility criteria and supporting documentation requirements' to 'Meeting the eligibility criteria for priority determination applications: biologicals' as part of migration to new 'Guidance' content type:
Original publication.
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