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
• advertising compliance, including what constitutes a breach, potential penalties and how to make a report

This podcast series is presented by the SME Assist team at the 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 advertising hub https://www.tga.gov.au/hubs/advertising-therapeutic-goods
• The Australian regulatory guidelines for advertising therapeutic goods https://www.tga.gov.au/publication/australian-regulatory-guidelines-advertising-therapeutic-goods-argatg
• Therapeutic goods advertising code https://www.tga.gov.au/publication/therapeutic-goods-advertising-code
• Compliance management https://compliance.tga.gov.au/
• Advertising enforcement and outcomes https://www.tga.gov.au/advertising-enforcement-and-outcomes
• Learning resources for advertisers https://www.tga.gov.au/learning-resources-advertisers
• Can I advertise this therapeutic good to the public? https://www.tga.gov.au/can-i-advertise-therapeutic-good-public
• Mandatory information required in advertising for therapeutic goods https://www.tga.gov.au/mandatory-information-required-advertising-therapeutic-goods

Host: Dr Jayne Foster

Guest: Leanne McCauley

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

We also learn about some of the innovative ways TGA is working with manufacturers of medicines and biologicals including some of the technology being used for remote inspections.

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
• Manufacturing therapeutic goods https://www.tga.gov.au/manufacturing-therapeutic-goods
• Manufacturing inspections https://www.tga.gov.au/manufacturing-inspections
• Manufacturing basics https://www.tga.gov.au/manufacturing-basics
• Good manufacturing practice - an overview https://www.tga.gov.au/good-manufacturing-practice-overview
• What type of GMP application do I require? https://www.tga.gov.au/good-manufacturing-practice-application-decision-tree

Host: Steven Smith-Fleury

Guest: Nadia Saleh

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 at TGA 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
• tips for sponsors providing samples to TGA for testing

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
• TGA Laboratories https://www.tga.gov.au/tga-laboratories
• Testing of face masks and respirators https://www.tga.gov.au/testing-face-masks-and-respirators
• Guidance on medical/surgical face masks and respirator standards - key performance aspects https://www.tga.gov.au/publication/guidance-medicalsurgical-face-masks-and-respirator-standards-key-performance-aspects
• Testing of therapeutic goods https://www.tga.gov.au/testing-therapeutic-goods
• Database of TGA laboratory testing results https://www.tga.gov.au/ws-labs-index

Host: Dr Jayne Foster

Guests: Dr Lisa Kerr and Lucan Baillie

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
• the application process

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
• Disinfectants, sterilants and sanitary products https://www.tga.gov.au/disinfectants-sterilants-and-sanitary-products
• COVID-19 landing page https://www.tga.gov.au/collection/covid-19
• Australian regulatory guidelines for medical devices (ARGMD) https://www.tga.gov.au/publication/australian-regulatory-guidelines-medical-devices-argmd
• Australian regulatory guidelines for OTC medicines (ARGOM) https://www.tga.gov.au/publication/australian-regulatory-guidelines-otc-medicines-argom-0
• Is my product a therapeutic good? https://www.tga.gov.au/sme-assist/my-product-therapeutic-good
• Is my product a medical device? https://www.tga.gov.au/my-product-medical-device
• What classification is my medical device? https://www.tga.gov.au/sme-assist/what-classification-my-medical-device

Host: Steven Smith-Fleury

Guest: Brian Chamberlain

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