Hitting the Accelerator
The Therapeutic Goods Administration’s (TGA) priority pathway provides a formal mechanism for faster assessment of vital and life-saving prescription medicines.
The priority review pathway is suitable for products with a strong unmet need where there are no other treatments available and/or the product is better than existing registered products. Medicines intended for submission via the provisional pathway are not eligible for a priority review.
What medicines are eligible for the priority review pathway?
Applicants must secure TGA approval of a priority determination for their application prior to submission of a registration application. The eligibility criteria for priority determination are designed to ensure that only medicines providing the most benefit to patients are approved.
All approved priority determinations are published on the TGA website here.
To qualify for a priority determination the application must:
- be intended to treat a serious condition and either be a new medicine or a new use for an existing medicine;
- represent a major therapeutic advance for treating the condition based on the data available and
- compares favourably in terms of safety or efficacy against any existing therapeutic goods used for the condition.
The TGA strongly encourages applicants who consider their medicine is suited to the priority review pathway to organise a pre-submission meeting, preferably 6 months prior to the planned submission date. Additionally, modified arrangements for the submission of GMP applications are required to be met. More information on the priority determination process and pathway is available here.
How is the priority review pathway different to the standard registration process?
Just like the standard regulatory pathway, the priority review regulatory evaluation is based on a complete regulatory dossier that comprehensively demonstrates quality, safety and efficacy. The target TGA evaluation timeframe for evaluation is 150 working days, which is up to three months shorter than the standard prescription medicines registration process. The cost structure for priority review applications is higher than for standard TGA prescription medicine applications, with application potentially incurring TGA fees for the priority request determination and the regulatory evaluation fee.
In terms of the regulatory process, instead of fixed regulatory milestones, priority review applications have dynamic evaluation milestones and TGA questions can be sent to applicants at any time during the evaluation (unlike the Milestone 3 consolidated questions in a standard review process). Priority review applicants are generally required to respond within 2 weeks of requests for information and must nominate a 30-day response timeline for any remaining questions received once the initial evaluation has been completed (vs. a choice of either 30 or 60 days for standard review applications). If all rolling questions have been responded to by the end of the first round of evaluation, then the evaluation can proceed to the next phase more expediently. In addition, for priority review applications there are more flexible arrangements for the TGA to access expert advice during the evaluation.
Whilst the priority review pathway is not appropriate for all products, where there is a high unmet medical need, and the available clinical development suggests the proposed treatment is better than any existing options it can provide a path that will ultimately allow patients earlier access to medicines that treat life-threatening or seriously debilitating conditions.
If you are considering an opportunity for your medicine to be authorised in Australia and think that it meets the criteria for the priority review pathway, please contact Brandwood CKC for assistance or further information.
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