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Navigating the Complexities of Medicine Registration

Evaluating alternative regulatory pathways for a timely and cost-effective registration process

For a sponsor considering entering the prescription medicine space, it is important to consider all possible regulatory pathways

The standard prescription medicine registration process, from acceptance for evaluation through to the delegate’s decision, has a legislated commitment of 255 working days and can cost up to $258,450 in application and evaluation fees. Therefore, exploring alternative pathways may save time and money.

The COR Pathway: Accelerated Medicine Registration in Australia through Overseas Assessments

The comparable overseas regulators (COR) pathway offers sponsors of medicines shortened TGA evaluation timeframes by utilising completed assessment reports from an eligible overseas regulatory agency. Overseas regulators can be eligible for participation in the COR registration pathway based on several criteria, including:

  • The degree of similarity and robustness of the country’s regulatory framework with the TGA
  • The consistency of the international guidelines and standards used
  • The ability of the participating regulator to release reports in English

Where prescription medicines have already been approved by a COR, duplication of the medicine evaluation is reduced, while the medicine standards for products supplied in Australia are maintained.

  • COR-A applications are evaluated in 120 working days, with the TGA decision based on a critical review of the COR assessment reports and an evaluation of the Australian label, Product Information (PI) and where required, the Risk Management Plan (RMP). The full overseas approval for the medicine cannot be older than 1 year.
  • COR-B applications are evaluated in 175 working days, with the TGA decision based on largely a critical review of the COR assessment reports, in combination with a TGA evaluation of certain data and the label, PI and RMP. Under the COR-B pathway, there is an allowable difference in the data presented to TGA for evaluation compared to the overseas regulator.

Project Orbis: International Collaboration for Evaluating Promising Cancer Treatments

Project Orbis is an initiative of the FDA’s Oncology Centre of Excellence that aims to provide patients with faster access to promising cancer treatments from around the world. This initiative consists of a collaborative review approach where multiple international regulatory partners, including the TGA, combine to evaluate new medicines and extensions to existing medicines.

  • Project Orbis Type A applications are evaluated by the TGA in parallel with the FDA and allows the participating regulatory agencies to share review documents, exchange requests for information and observe and participate in multi-country discussions.
  • Project Orbis Type B applications are evaluated by the TGA provided no more than 30 days have lapsed since submission to FDA.  The process allows the participating regulatory agencies to receive FDA review reports, exchange or receive requests for clarification and observe and participate in some multi-country discussions.
  • Project Orbis Type C applications are evaluated by the TGA after the FDA has completed a full evaluation of a medicine. This pathway allows the FDA to share their completed review documents to the participating regulatory agencies to assist them in their evaluation.

The TGA evaluation timeline for Project Orbis applications is 255 working days unless the medicine is under priority review.

ACCESS Consortium: Streamlined Evaluation Process for Medicines in Multiple Countries

If the same medicine dossier is to be submitted in Australia, Canada, Singapore, Switzerland and the United Kingdom, the medicine may be eligible to be evaluated by the Australia-Canada-Singapore-Switzerland-United Kingdom (ACCESS) Consortium. The ACCESS Consortium consists of a combination of regulatory authorities that work together to promote greater regulatory collaboration and alignment of regulatory requirements.

This pathway enables work sharing and information sharing amongst the regulatory agencies so that a medicine can be evaluated at the same time in the ACCESS countries, streamlining the approval process. ACCESS applications in Australia are evaluated within 255 working days.  

Priority Review Pathway

Why not see if your medicine is eligible to be evaluated by TGA quicker than the standard time frame? Pending meeting the eligibility criteria, the priority review pathway will have your medicine evaluated in just 150 working days instead of the standard 255 working days.

Provisional Determination: Medicines with limited clinical data

If you have limited clinical data, the medicine may be eligible for the provisional determination pathway, whereby if your data shows promising efficacy results, you have a plan to create a more robust dataset and your risk-benefit profile is favourable, you may be eligible to a provisional registration.

Pending meeting the eligibility criteria, the provisional pathway will have your medicine evaluated in 255 working days and will to get your medicine to those who need it most while generating your final data at the same time.

Benefits of Orphan Drug Designation

The product may be eligible for an Orphan Drug Designation (ODD), where the medicine is required to meet certain eligibility criteria, one of which is intended to treat a condition affecting fewer than 5 in 10,000.

Sponsors who are successful at obtaining an ODD for the medicine have their TGA application and evaluation fees waived.  It is possible to have both an ODD and Priority Review, which means your product could be evaluated in 150 days and without the fees.

Streamlining the Entire Regulatory Pathway with Commercial Eyes

At Commercial Eyes, we offer a comprehensive range of commercialisation services to help streamline the entire regulatory pathway. Our clients can benefit from our expertise in product registration through complex regulatory pathways and post-approval considerations like Pharmaceutical Benefits Scheme (PBS) listing. By incorporating these elements into one streamlined process, our clients can optimise their medicine dossier to ensure it works for them. With 21 years of experience, our team of experienced consultants can take the stress out of navigating the complex strategic options for your medicine, delivering timely and cost-effective solutions.

If you are looking to develop your submission strategy and require support, please contact our experienced team at [email protected]