We speak with Gillian Mitchell, First Assistant Secretary of the Regulatory Practice and Support Division at TGA and learn about: the role of TGA; what a therapeutic good is; the Australian Register of Therapeutic Goods; how the COVID-19 pandemic has impacted operations at TGA; and accessing unapproved therapeutic goods like medicinal cannabis.

In this episode, we talk with Brian Chamberlain from the Medical Devices Authorisation Branch at TGA and explore: some of the products being supplied for COVID-19; how these are regulated; where to start if considering supplying these products in Australia; how the features of a product can impact how it’s regulated; tools and information helpful for those new to supplying therapeutic goods; and the application process.

In this episode, we take a peek behind the curtains of the TGA laboratories with Dr Lisa Kerr, Assistant Secretary of the Laboratories Branch at TGA and Lucan Baillie, Director of the Biomaterials and Engineering section in the Laboratories Branch, to discuss: the history of the TGA labs and what actually happens there; what and how we test therapeutic goods; the current face mask testing program; and tips for sponsors providing samples to TGA for testing.

Join us for this episode as we speak with Nadia Saleh, Inspector in the Manufacturing Quality Branch at TGA and discuss: what role TGA plays in ensuring quality manufacturing practices and why this is important; what Good Manufacturing Practice (GMP) is; how this applies to manufacturers of medicines and biologicals; the inspection process; how COVID-19 has affected the way we work; and some of the innovative ways TGA is working with manufacturers of medicines and biologicals including some of the technology being used for remote inspections.

In this episode, we be speak with Leanne McCauley, Director of the Advertising and Compliance, Education and Policy Section at TGA about: what you can and can’t do when advertising therapeutic goods; what constitutes an advertisement; what responsibilities a sponsor has when advertising product; how the world of social media, including hash tags and testimonials, ties into advertising; some tips and pointers for those working in this space; and advertising compliance, including what constitutes a breach, potential penalties and how to make a report.