Regulation Impact Statement Updates

Official website for publishing regulatory impact analysis information for regulatory decisions announced by the Australian Government, COAG and COAG Councils.

Government Response to the Review of Medicines and Medical Devices Regulation

Aust Gov
7th December 2016

Independent Review – Department of Health

On 15 September 2016, the Minister for Health announced Reforms to Regulation of Medicine and Medical Devices.

These reforms are based on recommendations from the Independent Review of Medicines and Medical Devices Regulation conducted by an expert panel.

The purpose of the Review was to identify areas of regulatory burden that could be removed or streamlined to encourage innovation and global competitiveness in the medicines and medical devices sector.

Of the Review’s 58 recommendations, 56 are supported by the Government, with the majority of these supported in-full. The resulting reforms are expected to reduce regulatory burden for the industry and expedite patient access to medicines, without compromising safety, quality or efficacy of medicines and medical devices.

Under the Government’s best practice regulation requirements, a Regulation Impact Statement (RIS) is not required for a regulatory proposal where an independent review or other mechanism has undertaken a process and analysis equivalent to a RIS.

The Office of Best Practice Regulation does not assess independent reviews. Instead, an agency is required to self-assess (at the Secretary or Deputy Secretary level) whether a review meets the best practice requirements.

The Independent Review has been certified at the Deputy Secretary level by the Department of Health, as consistent with best practice.

Department of Health has estimated that the reforms will result in a reduction in regulatory costs of $75 million per year. The Office of Best Practice Regulation has agreed with this figure.

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