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
Speaking at the World Stem Cell Summit hosted by the Regenerative Medicine Foundation, Hogan Lovells partners Mike Druckman, Ernesto Algaba, Mandi Jacobson, Lu Zhou, Mikael Salmela, Charlotte Damiano, and Lowell Zeta, along...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
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
Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more
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