The Access Consortium New Active Substance working-sharing procedure – An Australian perspective
- Overview of TGA's reliance pathways and principles- where does Access fit?
- What is Access
- Key features of the work-sharing procedure
- TGA perspectives
Historically, most regulators have undertaken a de-novo comprehensive evaluation of pharmaceutical applications regardless of whether they have been reviewed and approved elsewhere. However, regulators are now looking at ways to share their workloads and collaborate with other health authorities to streamline the review and approval of new products.
In this session the Australian Therapeutic Goods Administration will provide an outline of recent programs and pilots which facilitate the evaluation activities and timelines through the recognition of product evaluations and approvals by comparable overseas regulators. This session will focus on the Australia-Canada-Singapore-Switzerland-United Kingdom (Access) New Active Substance work-share procedure and will include case studies and commentary on the TGA’s experiences with this innovative pathway.