The Australian Therapeutic Goods Act regulates the import, export, manufacture and supply of therapeutic goods in Australia. It is a complex regulatory regime and its application can sometimes catch clients unaware.
We regularly advise clients on their compliance with the regulatory regime, including advertising and labelling requirements and conduct of clinical trials.
With the growth in digital health and other innovative health and medical technologies, we also assist clients navigate the path to market for new products at the boundaries of current regulation (including advising on related issues such as privacy). Our team also advises clients on the interfaces between therapeutic goods, foods and cosmetics.
Advised on the University’s role acting as a local sponsor for a phase II clinical trial. Our advice made recommendations on the contractual, structural and regulatory arrangements that should be put in place to manage risk and achieve compliance. We also reviewed and advised on amendments to draft contractual documentation provided by the overseas sponsor, including with respect to the ownership and licensing of intellectual property rights produced during the clinical trial.