Australia Consults On 150-Day Priority Review, Provisional Approval
Executive Summary
Plans for new speedier routes to market are moving ahead as the Australian government announces a public consultation on the proposals for priority review and provisional approval pathways that were announced in September.
You may also be interested in...
Australian Provisional Approval Pathway To Get Tough On Sponsors Upfront
Plans by Australia’s Therapeutic Goods Administration to develop a provision approval pathway for drugs have moved up a gear.
No Delays Expected As Australian Bill On Faster Drug Approvals Goes To Parliament
The Australian parliament has held its first reading of a bill that will implement a number of new measures in the pharmaceutical area, including two new expedited drug approval pathways and a risk-based approach to variations.
English A Must In Australian Proposals On Using Overseas Assessments
Australia believes that using overseas assessment reports will help the Therapeutic Goods Administration cut the time it takes to review drug applications by up to three months. Meanwhile, a work-sharing scheme could make it easier for applicants to enter multiple international markets.