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Education priorities 2018-19

29 October 2018

The TGA is committed to delivering a range of educational materials for sponsors, health professionals and consumers in 2018-19. Many of our priority areas for education relate to reforms implemented following the Expert Panel Review of Medicines and Medical Devices Regulation (MMDR).

Below is information on our high priority education programs for 2018-19.

On this page: Advertising of therapeutic goods | Priority and provisional pathways | Listed Assessed pathway | Claimer | SME Assist | Permitted indications - From November 2018 | Reporting adverse events campaign - March 2019 | Manufacturing quality | Medical devices

Advertising of therapeutic goods

A number of changes to the regulation of advertising of therapeutic goods are being implemented between 2018 and 2020 following the Expert Panel Review of Medicines and Medical Devices Regulation (MMDR), including enhanced sanctions and penalties and a streamlined complaints handling system.

What we did for advertisers

What we did for consumers

Advertising continues to be a high priority for education resources with further plans for 2018-19, including detailed guidance, fact sheets, and a number of face-to-face training sessions in major capital cities.

Priority and provisional pathways

Part of our response to the MMDR includes the introduction of the priority review and provisional approval pathways. The provisional approval pathway allows time-limited registration of certain promising new medicines on the Australian Register of Therapeutic Goods (ARTG) without all supporting data. The priority review pathway involves faster assessment of vital and life-saving prescription medicines for which a complete data dossier is available.

What we are doing for health professionals

  • New web page
  • Webinar
  • Article in health professional journal/newsletter
  • Social media posts
  • E-Learning module

What we are doing for consumers

  • New webpage
  • Fact sheets: Is my provisionally approved medicine safe?, The difference between standard approval, priority review and provisional approval
  • Videos
  • Social media posts

Listed Assessed pathway

In response to the MMDR, the TGA is implementing a third pathway for sponsors of listed medicines to enter products in the ARTG. The AUST L(A) pathway sits between the current listed (lower risk) and registered (higher risk) pathways.

What we are doing for sponsors

What we are doing for health professionals

  • Web information
  • In-pharmacy materials
  • Social media posts

What we are doing for consumers

  • Web information: How complementary medicines are regulated, How to read medicine labels, What AUST L(A) means
  • Fact sheets
  • Social media posts
  • In-pharmacy materials

Claimer

Listed assessed and registered complementary medicines which have undergone successful pre-market assessment by the TGA will have the option to publish a 'claimer' that the product has been assessed for efficacy.

What we are doing for sponsors

  • Web information
  • Guidance document
  • Fact sheets
  • Webinar

What we are doing for consumers

  • Web information: What is the listed-assessed medicine claimer and what does it mean?
  • Fact sheets
  • Social media posts

SME Assist

We provide support services and education for small and medium enterprises in the therapeutic goods industry. This includes face to face workshops, online content, interactive tools and a dedicated email and phone service. A number of activities are planned for 2018-19 to continue supporting SMEs.

What we are doing for sponsors

  • Targeting start-up enterprises
  • Providing more educational support for researchers
  • Expanding reach through webinars and social media

Permitted indications - From November 2018

What we will do for sponsors

  • Web information: What is the new process to list a medicine on the ARTG using permitted indications and what is the transition arrangement?
  • Guidance document
  • E-Learning module
  • Webinars
  • Fact sheet
  • Letters

Reporting adverse events campaign - March 2019

Encouraging the public to report adverse events (unexpected side effects) is a significant and ongoing patient safety focus for the TGA. In addition to other education activities, we will be undertaking a larger scale campaign in 2019 to reach consumers in GP clinics and pharmacies.

What we will do for consumers

  • GP waiting room videos: Report adverse events to your doctor or the TGA
  • Digital screens displayed in pharmacies: Report unexpected side effects to your doctor or the TGA
  • GP brochures/pamphlets for doctor surgeries: How to report adverse events
  • Social media post reminders

Manufacturing quality

The TGA is adopting version 13 of the Pharmaceutical Inspection Cooperation Scheme (PICS) and will continue providing education to industry on this Scheme and Good Manufacturing Practice (GMP).

What we will do for manufacturers

  • Webinars and industry forums
  • Continuing GMP Industry Working Group
  • Guidance documents relating to v13 of PICS

Medical devices

The TGA is committed to increasing consumer awareness of medical devices, including their purpose and possible risks. We are also working to help health professionals understand how they can access certain unapproved medical devices for their patients through the Special Access Scheme.

What we will be doing for consumers:

  • Introducing the 'patient implant card' system which will be provided to patients who receive implantable medical devices
  • Increasing awareness through social media
  • Updating web content

What we will be doing for health professionals:

  • Updated Q&As on the TGA website
  • Tailored web content for accessing medical devices through the Special Access Scheme
  • Social media

These are just our high priority education areas and we'll continue to develop education resources on other topics. If you have any questions or feedback on this information please contact tga.education@tga.gov.au.