2022: Jun May Apr Mar Feb Jan

2021: Nov Oct Sep Aug Jul Jun

June 2022

• Unique Device Identification Webinar #10, 21 June 2022
  Information for manufacturers, sponsors and users of UDI data on how to access the AusUDID Sandpit.

May 2022

• TGA presentations: 2022 ARCS Annual Conference, 23-25 May 2022
  TGA presentation slides from ARCS Conference, Sydney (23-25 May 2022).
• Unique Device Identification Webinar #9, 17 May 2022
  Information webinar to discuss and share guest speaker experiences in implementing innovative software solutions to improve Unique Device Identification.
• Personalised medical device framework, 12 May 2022
  Presentation on medical device regulations at the ATSA Independent Living Expo 2022.
• Information on the TGA Good Clinical Practice (GCP) Inspection Program, 9 May 2022
  An overview of the new Good Clinical Practice (GCP) Inspection Program guidance document.

April 2022

• Unique Device Identification Webinar #8, 19 April 2022
  Information webinar including questions and answers, to discuss and share guest speaker experiences from Arthrex.
• Medicinal cannabis reforms, 6 April 2022
  Information on the new requirements for medicinal cannabis products in Australia.

March 2022

• Export of medicines guidance, 31 March 2022
  Guidance material about exporting therapeutic goods from Australia that aligns with current legislation, policy and business operations.
• Reporting medicine adverse events, 30 March 2022
  TGA presentation slides from eMedication Management Conference, Sydney (29-30 March 2022).
• Information session on the revised evidence guidelines for listed medicines, 23 March 2022
  The TGA providing an overview of the revised evidence guidelines for listed medicines.
• Unique Device Identification Webinar #7 - Global manufacturer UDI learnings, 22 March 2022
  A presentation on the current status of the work to establish the Australian UDI system, and questions and answers.
• TGA evidence expectations for medical devices or surfaces with anti-viral or anti-microbial claims, 2 March 2022
  General regulatory requirements of medical devices, what antiviral claims can be made and types of evidence required.

February 2022

• 2021 Therapeutic Goods Advertising Code, 17 February 2022
  Guiding advertisers through the new Therapeutic Goods Advertising Code 2021. It will highlight the changes to the 2021 Code compared to the 2018 Code and explain compliance obligations for advertisers during the six-month transition period and from 1 July 2022 when the 2018 Code will be repealed.

January 2022

• 2021 Therapeutic Goods Advertising Code, 20 January 2022
  Guiding advertisers through the new Therapeutic Goods Advertising Code 2021. It will highlight the changes to the 2021 Code compared to the 2018 Code and explain compliance obligations for advertisers during the six-month transition period and from 1 July 2022 when the 2018 Code will be repealed.

November 2021

• Application for consent to import, supply, or export a medical device non-compliant with the Essential Principles, 29 November 2021
  Consent to supply medical devices that are non-compliant with the Essential Principles (EPs)
• Medicinal cannabis - Changes to Special Access Scheme (SAS) and Authorised Prescriber applications, 23 November 2021
  Guiding you through applying to prescribe 'unapproved' medicinal cannabis products by category of active ingredient.
• Medicinal cannabis - Changes to sponsor requirements for supplying unapproved medicinal cannabis products in Australia, 22 November 2021
  Guiding you through your requirements as a sponsor of an unapproved medicinal cannabis product
• Medicinal cannabis - Changes to Special Access Scheme (SAS) and Authorised Prescriber applications, 22 November 2021
  Presentation explaining how medical practitioners can apply to access certain medicinal cannabis medicines via the Authorised Prescriber Established History of use pathway
• ICH-E2C(R2) guideline and PBRER template: concept, principles and regulators’ expectations, 18 November 2021
  A presentation by the TGA for the International Society of Pharamacovigilance (ISoP) Annual Meeting 2021 – Post conference course III.
• TGO93 testing and regulation of medicinal cannabis, 18 November 2021
  A presentation by the TGA for the 3rd International Conference on Food Analysis.
• Unique Device Identification Webinar #6 - 2021 Wrap-up and Q & A, 16 November 2021
  A presentation on the current status of the work to establish the Australian UDI system, and questions and answers.
• Regulation of products with tradition of use at the Food/Cosmetic-Medicine interfaces, 16 November 2021
  A regulatory perspective on the Food-Medicine and Cosmetic-Medicine interfaces, including a description of the criteria and tools used to categorise products at the interface.
• Adverse event reports of hip prostheses and prediction of prostheses with higher than anticipated rates of revision, 11 November 2021
  A presentation by the TGA for the International Congress of Arthroplasty Registries.
• Relying on combined global, regional and country information in pharmacovigilance, 10 November 2021
  A presentation by the TGA for the International Society of Pharmacovigilance Annual Meeting.

October 2021

• Meeting your obligations - Supplying medicinal cannabis in Australia, 21 October 2021
  SME Assist has now published its online workshop - Meeting Your Obligations - Supplying medicinal cannabis in Australia
• Cracking the code: Developing requirements for data matrix codes on medicines, 20 October 2021
  A presentation on Cracking the code: Developing requirements for data matrix codes on medicines by Tony Manderson at the RACI PSG Conference
• Nicotine vaping products, the UK smoking cessation experience, 20 October 2021
  A presentation on Practical and clinical experience in the practice of smoking cessation treatments in the UK
• Webinar 2: Application for consent to import, supply, or export a medical device non-compliant with the Essential Principles, 20 October 2021
  The TGA is modernising this process to move from a standalone paper-based form to an online form
• Application for consent to import, supply, or export a medical device non-compliant with the Essential Principles, 19 October 2021
  The TGA is modernising this process to move from a standalone paper-based form to an online form
• Unique Device Identification Webinar #5, 19 October 2021
  A presentation on the role of a UDI Issuing Agency, including project update and Q&A
• Nicotine vaping products, the NZ smoking cessation experience, 15 October 2021
  The role nicotine vaping products can play in a person's journey to quit
• Pharmacovigilance - a regulator's perspective, 13 October 2021
  This presentation delivered on behalf of the TGA to the students at the University Technology of Sydney as part of the Master of Pharmacy course

September 2021

• Good Manufacturing Practice inspections during the pandemic – an Australian perspective, 22 September 2021
  Presentation from TGA for the Vl all Russia Good Manufacturing Practice (GMP) Conference
• The role of a UDI Issuing Agency, 21 September 2021
  Information on the creation of UDIs and the role of an Issuing Agency
• Engaging with the TGA, 8 September 2021
  Engaging with the TGA on the topic of medical device regulation, including Software as a Medical Device (SaMD), the inclusion process, resources available for sponsors etc.
• An introduction to regulation of medical devices in Australia, 6 September 2021
  Presentation from TGA Lecture at Biomedical engineering Department.

August 2021

• Challenges and considerations on the journey to a global UDI system, 17 August 2021
  A presentation and Q&A on UDI from a perspective of a global medical technology company.

July 2021

• TGA Transformation Stakeholder Engagement Forums, 29 July 2021
  The TGA is embarking on a transformation program to change and improve the way we deliver services to our stakeholders.
• Considerations for the Australian UDI, 20 July 2021
  Further considerations for the Australian UDI, including global alignment, GMDN and data elements.

June 2021

• Medical device regulatory lifecycle, 25 June 2021
  Presentation given by the TGA for a Queensland Cardiovascular Research Network Webinar.
• Unique Device Identification, 15 June 2021
  An introduction to the Australian Unique Device Identification system, including Q&A.
• 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.