Australia: The Regulatory and Reimbursement Environment
This article is the third in a three-part series that aims to provide sponsors with information about Australia as a highly attractive option for drug research and development. Australia offers a mature infrastructure and experienced, capable local resources, especially important given global geopolitical uncertainties. Here, we examine the clinical trial start-up processes, regulatory pathway, market access, pricing system, and pricing control, with particular emphasis on cell and gene therapy with a case study to illustrate.
Interested in more? Check out part 1 and part 2.