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
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