Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

Australia Plans New Approval Pathways To Foster Earlier Access To Novel Drugs

Executive Summary

The Australian government has come up with a set of proposals for reforming the drug and medical device regulatory framework, which include speeding up access to innovative drugs through expedited and provisional approval mechanisms and greater use of assessments by overseas regulators. The changes will be phased in over a period of about three years and may include some recovery of costs from industry.


Related Content

Australia To Make Access To Unauthorized Products Faster And Less Bothersome
No Delays Expected As Australian Bill On Faster Drug Approvals Goes To Parliament
English A Must In Australian Proposals On Using Overseas Assessments
Australia Consults On 150-Day Priority Review, Provisional Approval
Australia Gets Tough on Orphan Drug Makers: Delay Filing and Designation Will Lapse
Landmark review calls for faster drug approval pathways in Australia