TGA - SME Assist ‘Navigating therapeutic goods regulation‪‘‬ SME Assist

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