You are here
- Webinar presentation: Unique Device Identification, 15 June 2021
An introduction to the Australian Unique Device Identification system, including Q&A
- Webinar presentation: Proposed improvements to the Therapeutic Goods Advertising Code, 3 June 2021
An overview of the key issues contained in the public consultation paper. The consultation is seeking feedback on options for improving the clarity and performance of the Code.
- Webinar presentation: Quality Control of Biotechnological or Biological Medicines, 25 May 2021
Manufacturing quality perspective
- Presentation: EU Medical Device Regulation: Implications for the TGA and Australia, 18 May 2021
EU Medical Device Regulation changes and the implications for the TGA and Australia.
- Webinar presentation: Medicinal cannabis advertising compliance, 18 March 2021
Advertising rules and responsibilities, including how they may affect the preparation of public facing communications and other activities.
- Webinar presentation: Special Access Scheme Portal, 11 March 2021
Walkthrough changes to the SAS Category B forms and Authorised Application form.
- Webinar presentation: TGO 110: Standard for unapproved vaporiser nicotine products, 4 March 2021
An overview of TGA's proposed safety and quality requirements for unapproved vaporiser nicotine products
- Medicinal cannabis advertising compliance, 3 March 2021
Overview to assist industry and other interested parties to understand their obligations in regards to advertising medicinal cannabis.
- The regulation of medical device software, February 2021
An overview of medical device software regulation in Australia.
- Webinar presentation: Australian Dental Industry Association (ADIA), 16 February 2021
Overview of the new framework including regulatory concepts and worked examples for the dental industry
- Webinar presentation: Australian Orthotic Prosthetic Association (AOPA), 16 February 2021
Overview of the new framework including regulatory terminology and worked examples
- Webinar presentation: Personalised Medical Devices Framework
Guidance for industry on the new regulatory framework for personalised medical devices commencing on 25 February 2021.
- Webinar presentation: Section 7 Declaration that certain sports supplements are Therapeutic Goods
Help sponsors to understand the changes to the regulation of sports supplements arising from the recent declaration
- Webinar recordings and presentations: Proposed changes to the way nicotine is supplied, 8 and 9 October 2020
Information sessions to explain the interim decision on nicotine
- Webinar presentation: Remote Inspections from TGA manufacturing quality perspective
Remote Inspections from TGA perspective - Impact of Covid-19 Restrictions on Manufacturers and Test Laboratories
- Online presentation: Work-sharing, reliance, and other novel approaches to accelerating review, approvals, and access
An overview of TGA's comparable overseas regulator pathways and international work-sharing activities for prescription medicines. Delivered in a joint session with representatives from the US Food and Drug Administration and Health Canada.
- Webinar presentation: Adopting the improved CMI template - Information for sponsors, 22 July 2020
Changes and guidance on the new CMI template for sponsors
- Guidance on bioequivalence, 4 June 2020
New bioequivalence and biowaiver data summary templates to be included in the dossier for new generic prescription medicine submissions
- Webinar presentation: Supplying and advertising certain therapeutic goods for COVID-19, 28 May 2020
Information for new sponsors of hand sanitisers, disinfectants and personal protective equipment
- Webinar recording: SME Assist - Supplying and advertising therapeutic goods for COVID-19, 28 May 2020
Regulation requirements specific to hand sanitisers, disinfectants and Personal Protective Equipment for COVID-19