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MMDR: Prescription medicines regulatory reforms

14 November 2018

Reforms to the regulation of prescription medicines have been implemented in response to the recommendations arising from the Review of Medicines and Medical Devices Regulation.

The reforms include changes that will bring medicines to market sooner in Australia, while maintaining a robust framework for safety, quality and efficacy.

Reforms

Provisional approval pathway

The new provisional approval pathway allows for certain promising new medicines that show a major therapeutic advance for Australians to come to the market up to two years sooner than through standard processes.

Priority review pathway for prescription medicines

The new priority review pathway allows for a faster assessment of vital and life-saving prescription medicines, with a target assessment timeframe up to three months shorter than standard processes.

Notification process for minor variations to registered medicines

Introduction of a notification process for certain 'low risk' minor variations to registered medicines and biologicals, using electronic forms and automatic processes.

Comparable overseas regulators for prescription medicines

New processes allowing the better use of prescription medicine assessments from comparable international regulators and work-sharing with international regulators on joint evaluation reports.

Further information

Consultations related to prescription medicines

Up-to-date information about the reforms and their status.

Information on the Review of Medicines and Medical Devices Regulation, including links to the complete Review and the Australian Government's response.