On 5 August 2024, the Agreement Among the Government of Australia, the Government of the United Kingdom of Great Britain and Northern Ireland, and the Government of the United States of America for Cooperation Related to...more
Earlier this year, the Administrative Appeals Tribunal handed down its decision in a matter between Clearview AI and the Australian privacy regulator, the Office of the Australian Information Commissioner. Crucially, this...more
On 1 June 2023, the Federal Government released the Safe and Responsible Use of Artificial Intelligence in Australia Discussion Paper which set out a number of potential mechanisms and regulatory approaches through which AI...more
In a joint statement released by Prime Minister Albanese and President Biden, Australia and the United States have committed to a number of new agreements that may have a significant impact on climate and biodiversity action,...more
In support of Privacy Awareness Week and this year’s theme of ‘back to basics’, we provide you with an in-depth analysis of the key proposals that arise from the Attorney General’s Final Privacy Act Review Report (Report)...more
The Security of Critical Infrastructure (Critical Infrastructure Risk Management Program Rules) (LIN 23/006) 2023 (CIRMP Rules) came into force on 17 February 2023. Responsible entities for certain critical infrastructure...more
Increased penalties and wider application of the scope of the Privacy Act 1988 (Cth) (Privacy Act) come into effect shortly, with the Privacy Legislation Amendment (Enforcement and Other Measures) Bill 2022 (Bill) now...more
Australian regulation of cell, tissue, and gene therapies (CTGT) is relatively new, with the regulatory framework for biological medical products first being introduced in 2011. A decade onwards, the Therapeutic Goods...more
The second round of amendments to the Security of Critical Infrastructure Act 2018 (Cth) (SoCI Act) has now come into effect, with the Security Legislation Amendment (Critical Infrastructure Protection) Bill 2022 (Bill)...more
The Australian Government has released draft legislation aimed at ensuring Australia’s privacy law remains well equipped to tackle the next digital era. The exposure draft of the Privacy Legislation Amendment (Enhancing...more
The Department of Health (Department) has opened a public consultation on the review of the National Medicines Policy (NMP). As part of the review, the Expert Advisory Committee (Committee) is seeking feedback on a number of...more
On 29 July 2021, the Federal Court of Australia (the “Court”) handed down its largest ever pecuniary penalty for serious, sustained and knowing contravention of the Therapeutic Goods Act 1989 (Cth) (“TG Act”). The decision...more
Businesses are reminded to review their customer terms and conditions ahead of the impending changes to the Australian Consumer Law and unfair contract term regime, and ensure all internal policies are up to date....more
Recently, Ad Standards Australia (Ad Standards) found two social media influencers breached the Australian Association of National Advertisers Code of Ethics (the Code) in relation to their obligations to disclose paid...more
In 2020, heightened demand for health care resulted in an influx of therapeutic goods being included on the Australian Register of Therapeutic Goods (ARTG). A large portion of these goods are manufactured in China however,...more
3/18/2021
/ Australia ,
China ,
Coronavirus/COVID-19 ,
Infectious Diseases ,
Life Sciences ,
Manufacturers ,
Masks ,
Medical Devices ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Public Health ,
Regulatory Requirements ,
Supply and Demand ,
Supply Chain
The new classification rules for software-based medical devices (“SaMDs”) and personalised medical devices introduced by the Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 commences this week,...more