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
• accessing unapproved therapeutic goods like medicinal cannabis

This podcast series is presented by the SME Assist team at TGA. SME Assist is a dedicated service that TGA offers to help small to medium enterprises (SMEs), researchers, start-ups and those unfamiliar with regulation to understand their regulatory and legislative obligations.

You can find more information about TGA and SME Assist at www.tga.gov.au/sme-assist and through our social media channels or contacting us directly.

Phone: 1800 020 653

Email: sme.assist@tga.gov.au

Social Media: https://www.tga.gov.au/social-media

TGA BLOG: https://www.tga.gov.au/blogs/tga-topics

Links and useful information

• TGA website tga.gov.au
• The ARTG https://tga-search.clients.funnelback.com/s/search.html?query=&collection=tga-artg
• What is a therapeutic good? https://www.tga.gov.au/what-are-therapeutic-goods
• Software based medical devices https://www.tga.gov.au/regulation-software-based-medical-devices
• Risk based approach to regulation https://www.tga.gov.au/tga-regulatory-framework#risk
• Special Access Scheme (unapproved goods) https://www.tga.gov.au/form/special-access-scheme
• Authorised Prescribers (unapproved goods) https://www.tga.gov.au/form/authorised-prescribers
• Medicinal cannabis https://www.tga.gov.au/medicinal-cannabis
• Advertising hub https://www.tga.gov.au/hubs/advertising-therapeutic-goods
• Compliance and enforcement hub https://www.tga.gov.au/hubs/compliance-and-enforcement
• COVID-19 landing page https://www.tga.gov.au/collection/covid-19

Host: Dr Jayne Foster

Guest: Gillian Mitchell