How Australia’s TGA Priority Review Pathway Helps Speed Up Access to New Medicines.
The ultimate goal of every regulatory submission is patient access. Whether seeking approval for a new prescription medicine or an additional indication for an existing drug, the objective remains the same — providing patients with the best possible treatment options as quickly and safely as possible.
Speeding Up the Review Process
The Therapeutic Goods Administration (TGA)’s priority review pathway is a fast-tracked evaluation process that accelerates the evaluation of eligible medicines, reducing the time between submission and patient access.
Under the standard registration process a new medicine or indication undergoes evaluation for up to 255 working days following acceptance – typically around a year from initial submission.
However, medicines granted priority determination are usually evaluated within 150 working days, cutting the approval time by up to three months!
Eligible Therapeutic Goods
To qualify for priority determination, medicines must meet certain criteria. For a new medicine or additional indication for a serious condition, two key factors are assessed:
- The medicine must either be the first therapeutic good available in Australia for this indication or demonstrate a significant improvement in efficacy or safety compared to existing approved treatments.
- The medicine also must represent a major therapeutic advance in safety or efficacy.
This is to ensure that priority determination is granted to products that will be significantly beneficial to patients.
Considerations
If your product is eligible and you are deciding whether to pursue the priority determination pathway, there are several considerations that may factor into your decision.
Milestones:
The milestones of the priority review pathway differ from those of the standard process. After Milestone 2, companies face three-months of rolling questions, with typical response timeframes 14 calendar days. This accelerated pace can place significant strain on company resources.
Fees:
When deciding whether the priority determination pathway is right for your product, consider the associated fees should be considered. The priority review pathway comes with higher fees than the standard pathway, including an additional priority determination application fee.
Application Form:
It is also essential to consider the time required to prepare the priority determination pathway application. While this pathway can lead to TGA approval up to three months earlier than the standard process, the determination application demands significant time and resources. Additionally, the TGA has a target decision timeframe of 20 working days.
Having an experienced team to guide you through the complexities of the priority determination pathway is invaluable.
The Adjutor Advantage
The Adjutor Healthcare Group has extensive experience in registering medicines via the priority review pathway. Our consultants can provide hands-on assistance in all aspects of the process including –
- eligibility assessment
- TGA pre-submission advice and meetings
- Application preparation, through to
- The evaluation and approval process, and beyond.
At Adjutor Healthcare Group, we are committed to guiding you through every step of the priority review process—helping you navigate regulatory complexities and expedite patient access to your medicine.
Explore Australia’s TGA Priority Review Pathway
Need expert guidance on the TGA’s priority review pathway? Contact Adjutor Healthcare Group today to discuss how we can help streamline your regulatory submission.
