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The TGA has worked with comparable NRAs to develop work-sharing schemes and other reliance mechanisms to facilitate earlier access to novel prescription medicines for the Australian population [18, 19].There are currently seven pathways available to sponsors of prescription medicines in Australia, outlined below: Standard pathway, Priority Review, Provisional Approval, Comparable Overseas Regulator (COR)-A, COR-B and two worksharing and parallel review programs: International work-sharing Australia Canada Singapore Switzerland UK (Access) Consortium, and the Project Orbis with the U.S

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