While planning a clinical program it is valuable to consider the designations and determinations available through the Therapeutic Goods Administration (TGA). Where deemed appropriate, these pathways can help bring your product to market more quickly and with the potential for reduced costs.
The team at Mister Wolf Consulting (MWC) has collectively more than 80 years’ experience in the pharma and medtech industry and can provide valuable advice on how you might take advantage of these pathways.
There are four key pathways to consider:
- Orphan drug designation (medicines)
- Provisional determination (medicines)
- Priority review determination (medicines and medical devices)
- Comparable Overseas Regulator (COR) (medicines and medical devices)
Orphan drug designation (ODD) allows companies to pursue registration for new medicines, new indications, or new dosage forms for treating life-threatening or seriously debilitating conditions which are classified as rare conditions and/or are not financially viable.
The benefit to the sponsor is that the application and evaluation fees for the registration application are waived by the TGA to allow the company to reduce their costs associated with bringing such a product to market.
Orphan drug products must meet a list of eligibility criteria. The first criteria to consider is whether there are any other products on the ARTG registered for the treatment, prevention or diagnosis of the same condition. If not, then you can proceed to evaluate your product and indication against the remaining eligibility criteria.
Applications for orphan drug designation should be made at least 6 months prior to your planned registration application.
Provisional determination allows for a quicker registration based on preliminary clinical data. It provides a significant financial advantage allowing companies to achieve registration and commercialisation prior to completing their comprehensive clinical program, while bringing important products to patients where existing treatments are otherwise lacking.
For an application to be evaluated through the provisional registration pathway it must first have been approved for a provisional determination and must have the standard requirements for nonclinical and quality data and evidence of Good Manufacturing Practices.
To achieve a provisional determination the medicine must meet the eligibility criteria and the company must provide evidence that they will continue with the proposed clinical program. Furthermore, the company must be able to submit comprehensive clinical safety and efficacy data for evaluation prior to the end of the 6 years total provisional registration.
An application under the provisional approval pathway must be made within 6 months of being granted a provisional determination.
Priority review determination provides an opportunity for companies to have their medicine or medical device registration application evaluated and approved up to three months earlier than would be achieved through the standard registration pathway. Unlike the provisional pathway, priority review involves the same amount and type of evidence as the standard review process, and products reviewed under this process will receive full approval, identical to the standard registration pathway.
To be eligible for priority review determination the medicine or medical device must be a new product or an existing product with a new indication for the treatment of a serious or life-threatening condition which demonstrates a major therapeutic advance and with no comparator product registered on the ARTG.
To have a product reviewed via the priority review pathway, an application for priority determination is recommended to be submitted 3 months prior to submission of the marketing application. A priority review application must be made within 6 months of the priority determination being granted.
Comparable Overseas Regulator (COR) – While not strictly a designation or determination, there is a fourth pathway which has the potential to expedite your registration application in Australia. If your medicine or device has already gained marketing authorisation in a comparable global market, the TGA allow sponsors to apply an abbreviated registration strategy, potentially halving your evaluation timeframe.
You will need to demonstrate that the target regulator and their regulatory framework are sufficiently comparable, by TGA standards, and in addition, you will also need to check that the TGA has a MOU in place with your target regulator.
The date your product was approved by your COR, and the degree of variation in the original dossier since registration will dictate the length of evaluation the TGA will apply.
As with most deviations away from a standard pathway, presubmission consultation is recommended.
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While it is best to consider these alternative pathways during the development of your clinical program, in our experience it is never too late to consider alternative registration pathways.
MWC can help you explore these pathways to confirm if any may apply to your current situation. Give the team a call or email to discuss.
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