Therapeutic Goods Regulation and Advertising

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.

An experienced team with a deep understanding of our business.

Chambers Asia Pacific

Major social media platform

Advising on the application of the Therapeutic Goods Act to the rollout and launch of a new application with medical diagnostic features and regulations around software as a medical device.

Manufacturer of prescription products

Advising on advertising and marketing campaign for products to healthcare professionals including relevant restrictions under the Therapeutic Goods Act and Australian Consumer laws.

NASDQ listed US biotechnology company

Advised on the regulatory regime applicable to the conduct of clinical trials in Australia. Our advice assisted the company to understand what steps it would need to take in order to lawfully commence clinical trials in Australia.

Leading Queensland University

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.