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.


Open PDF

Return to Insights Center

Related Insights

Video

How to transition existing trials under EU-CTR

Feb 1, 2023

Blog

Ensuring future success in a new market by delivering a robust safety database solution

Aug 4, 2023

Blog

Adoption of the ICH Q12 guideline: New Horizons for Efficient Product Supply Chain Management for a Key Global Market

Nov 13, 2023

Article

Near-term strategies for biotech drug developers facing shifting healthcare dynamics

Feb 14, 2024

Video

Part 3: Risk-based Quality Management Video (RBQM) Series

Nov 11, 2021

Video

Part 2: Risk-based Quality Management Video (RBQM) Series

Nov 11, 2021

Article

Expedited Pathways Comparisons - US EU CHN

Oct 19, 2021

Article

Part 1 - Preparing for a Risk-Based Future: What ICH Revisions Mean for Clinical Trial Design and Conduct

Sep 14, 2021

Article

Decentralized trial tools and technologies are here to stay: A regulatory perspective

Jul 23, 2021

Article

Lessons from China and the United States on the use of RWE in regulatory submissions

Jul 19, 2021

Article

Australia: Infrastructure and Innovations for Clinical Trials

Aug 28, 2023

Report

New Medicines, Novel Insights: Advancing rare disease drug development

May 22, 2023