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The priority review pathway provides a formal mechanism for faster assessment of vital and life-saving biologicals.
The target timeframe of 150 working days is up to 105 days shorter than the timeframe for the standard assessment pathway.
Biologicals eligible for the priority review pathway
A determination process is used to assess the eligibility of a biological for the priority review pathway.
The determination process does not guarantee that a biological will be approved for inclusion in the Australian Register of Therapeutic Goods (ARTG) following assessment.
The eligibility criteria are designed to ensure that only biologicals providing the most benefit to patients are eligible for priority review.
The eligibility criteria that a biological must meet are that it is:
- a separate and distinct product
- for a serious condition
- not equivalent to a product in the ARTG or is a significant improvement over an approved product
- a major therapeutic advance.
For more information refer to priority determination eligibility criteria and supporting documentation requirements for biologicals.
Benefits of the priority review pathway
The priority review pathway for biologicals provides:
- consumers and health professionals with faster access to new biologicals for serious and life-threatening conditions
- alignment with existing priority pathways for prescription medicines and medical devices
- alignment with other overseas regulators that offer expedited pathways for approval of such products
- a predictable and transparent mechanism to formalise the expedited process for sponsors and TGA business areas.
Applications for priority review
Sponsors must first apply for a priority determination before lodging a priority review application for ARTG inclusion.
For more information on the application process refer to:
- Biologicals (priority applicant) determination: A step-by-step guide
- Biologicals priority inclusion process: A step by Step guide for biologicals with priority applicant determination