Regulation Impact Statement Updates
Official website for publishing regulatory impact analysis information for regulatory decisions announced by the Australian Government, COAG and COAG Councils.
Regulatory scheme for personalised medical devices, including 3D-printed devices
Regulation Impact Statement – Therapeutic Goods Administration
On 12 December 2019, the Minister for Health amended the Therapeutic Goods (Medical Devices) Regulations 2002 to incorporate reforms to the Australian medical devices regulatory framework.
The amendments address the rapid emergence of new technologies and rapid uptake of personalised medical devices; the continued need for international alignment; and the lack of suitable alternative mechanisms to manage issues...
In-service safety for automated vehicles
COAG Consultation Regulation Impact Statement – COAG Transport and Infrastructure Council
On 1 July 2019, the National Transport Commission (NTC) released for public consultation, a Regulation Impact Statement (RIS) examining the safe operation of automated vehicles on Australian roads.
The RIS has been prepared in accordance with Council of Australian Governments (COAG) requirements for the purpose of eliciting information to inform a decision by the COAG Transport and...
Anti-money laundering and counter-terrorism financing
On 17 October 2019, the Government introduced the Anti Money Laundering and Counter Terrorism Financing and Other Legislation Amendment Bill 2019 to Parliament.
The Bill amends the Anti-Money Laundering and Counter‑Terrorism Financing Act 2006 and the Criminal Code 1995, to implement the second phase of reforms in response to the recommendations of the Report on the statutory review of the Anti-Money Laundering and Counter-Terrorism Financing Act 2006 and associated Rules and...
Japan Australia Economic Partnership Agreement (JAEPA) Post-Implementation Review
On April 7 2014, then Prime Minister Tony Abbot and Prime Minister Shinzo Abe announced the conclusion of negotiations on the Japan-Australia Economic Partnership Agreement (JAEPA). This agreement was signed on 8 July 2014, and came into force on 15 January 2015.
A Regulation Impact Statement (RIS) was prepared by the Department of Foreign Affairs and Trade to support the decision to endorse the signing of the JAEPA. As this regulatory change was assessed as being highly significant,...
Bank Credit Risk Management
Independent Review – Australian Prudential Regulation Authority
On 12 December 2019, the Australian Prudential Regulation Authority (APRA) released a new prudential standard for banks and other authorised deposit-taking institutions (ADIs), Prudential Standard APS 220 Credit Risk Management, to replace Prudential Standard APS 220 Credit Quality from January 2021.
The standard places a requirement on ADIs to control credit risk by adopting prudent credit risk management policies...
Clarifying eligibility for origin claims in the Complementary Medicines Sector
Non-compliance with COAG’s best practice regulation requirements – Legislative and Governance Forum on Consumer Affairs (CAF)
On 12 December 2019, the Legislative and Governance Forum on Consumer Affairs (CAF) agreed interim and on-going measures to allow complementary medicines which meet certain Australian manufacturing eligibility requirements to make an Australian origin claim, and to have access to the Australian Made, Australian Grown (AMAG) logo. Further details can be found in...
Better Targeting the Research and Development (R&D) Tax Incentive
Regulation Impact Statement – Department of the Treasury
On 5 December 2019, the Treasurer introduced the Treasury Laws Amendment (Research and Development Tax Incentive) Bill 2019, which implements a revised version of the Better targeting the research and development tax incentive measure announced in the 2018-19 Budget and introduced into the previous Parliament in September 2018.
The 2018 Bill was accompanied by a Regulation Impact Statement (RIS) that had been assessed by...
Addressing prescription opioid use and misuse in Australia
Independent Review – Therapeutic Goods Administration
On 12 December 2019, the Therapeutic Goods Administration introduced changes to the regulatory framework for prescription opioids to address prescription opioid use and misuse in Australia.
Changes will include:Registration of smaller pack sizes for oral immediate-release prescription opioids. Requiring boxed warnings and class statements in the Product Information (PI) documents for all prescription opioids in...
Live sheep exports to, or through, the Middle East – Northern Hemisphere Summer
Regulation Impact Statement for consultation – Department of Agriculture
On 20 December 2019, a Regulation Impact Statement on live sheep exports to, or through, the Middle East during the Northern Hemisphere Summer was released for consultation.
The RIS presents three options to manage the risk of heat stress in live sheep exported to, or through, the Middle East during the Northern Hemisphere Summer. The RIS considers the impacts of the status quo; prohibiting live sheep...
Phasing out certain waste exports
COAG Consultation Regulation Impact Statement
On 20 December 2019, the Department of Environment and Energy released for public consultation a COAG Consultation Regulation Impact Statement (RIS) on phasing out certain waste exports.
On 9 August 2019 at the meeting of the Council of Australian Governments (COAG), Australia’s First Ministers agreed Australia should establish a timetable to ban the export of waste plastic, paper, glass and tyres, while building Australia’s...